Product Catalogue
gke Steri-Record® und gke Clean-Record®
Supporting your needs
Process challenge devices,
chemical indicators and accessories
for cleaning and sterilization processes
Product Catalogue
Product Catalog
Bowie-Dick-Simulation Test
Batch- and Process Monitoring System
Documentation System
steam, ethylene oxide, formaldehyde
®
®
peroxide sterilization
® ®
andand hydrogen
Clean-Record
Processprocesses
Steri-Record®
gke Steri-Record
und
gkegke
Steri-Record
Clean-Record
und gke Clean-
Challenge
Chemical
Indicators
and accessories
Cleaning
processes
Process Devices,
challenge
devices,
Process
challenge
devices,
for
cleaningindicators
and sterilisation
chemical
chemical
andprocesses
accessories
indicators and accessorie
10-002 EN V15 01/2012
Seite 1 von 24
for cleaning and sterilization
for cleaning
processes
and sterilization proce
• Bowie-Dick-Simulation Test • Batch and Process Monitoring System • Documentation System
• Steam, ethylene oxide, formaldehyde and hydrogen peroxide sterilisation processes • Cleaning processes
Sterilisation Assurance: Raising the Bar
Sterilisation of reusable medical devices is
the culmination of the decontamination
process. In principle, this should mean
that there are no viable microbiological
entities present, but also no residues
from the process, such as chemicals or
endotoxins, that could affect the next
patient on which a device is used.
How do we know that a device has
been sterilised? This article explores the
development of sterilisation validation
processes over the years, and looks at
current available options for best practice.
Meeting target temperatures, pressures,
and exposure time, and proof of the
presence of steam, has, for some time,
been taken as an initial indicator that a
cycle will have been effective in an empty
chamber in a steam steriliser. Measuring
temperature and pressure will be irrelevant
in a low temperature steriliser where the
sterilant is hydrogen peroxide, for example
in a plasma steriliser, and there will be a
need to show that there was an effective
dose of the sterilising chemical.
Bowie-Dick
The next development in sterilisation
assurance standards was the introduction
of Bowie-Dick tests, where a chemical
indicator is placed in the centre of a pack of
strips or at the end of a coiled tube device
(to mimic placement in the centre of a 7kg
cotton pack). Each day this is placed into
a steriliser to confirm that its operating
conditions can penetrate the test pack.
However, each different device behaves
differently within a load, and each
load behaves differently inside a given
chamber. A daily Bowie-Dick test in
an unloaded machine will provide no
assurance for these situations.
Another challenge is to
see what is happening at
the centre of a load: there
are test strips that can be
placed in the load, which can
be checked when the pack is
opened, but if the sterilisation
process had not been effective,
this will only be discovered at the
point of use. Rejecting an instrument
pack at this point could jeopardise a
surgical intervention.
2
The ideal test would be to have a biological
indicator present in every load in every
cycle, to show that the conditions have
been able to destroy the biological entity.
The disadvantage is that it takes time, from
several hours onwards, to show that the
entity will not grow, and thus be detected.
To overcome this, chemists have devised
a number of clever chemical indicators
which react differentially to temperature,
pressure, chemicals, etc to provide
evidence that cycle conditions have
reached deep into sterilisation loads,
and that the chemical changes detected
are parallel with biological kill rates for
specified microbes.
Medical device simulators
The answer to this problem has been
the development of medical device
simulators (MDS) which are designed
and validated to simulate the worst case
scenario for a specified medical device,
and can be placed in the steriliser next
to the pack containing the genuine
device. The MDS’s test strip can be
checked at the end of the cycle.
Batch Monitoring Systems and beyond
The next level of progress has been the
development of batch monitoring
systems (BMS) which are designed
and validated to test the worst case
situations for different specific load
configurations.
This means that each cycle can have
a means of validating the likely
efficacy of that cycle, with that
load, and that configuration.
A new standard was published in 2011 for
the test methods to prove the equivalence
between instruments and their MDS and
load configurations, and their BMS.
German company, GKE, has been at the
forefront in developing Process Challenge
Devices and Batch Monitoring Systems,
and these are now available in the UK
from BES Decon in Bristol.
As the sterilisation assurance standards bars
are raised, the next development will be a
sensitive test system using a biologically
based indicator, where the effectiveness
of the sterilisation process can be assessed
and recorded quantitatively. This system will
be on the market within the next couple of
years. Meanwhile, how high have you set
your safety bar?
Contents
1.0 Chemical Indicators to monitor steam sterilisation processes
4
1.1 Bowie-Dick-Simulation Test
4
1.2 Process Monitoring System (PMS)
7
1.2.1 Hollow load test for small and large sterilisers
8
1.2.2 High demand hollow PMS
10
1.2.4 Load related BMS
14
1.2.5/6 Chemical indicator strips for BMS (steam)
14
1.3 Pack Monitoring Indicators for steam sterilisation processes
16
1.3.1 Class 4 indicators
16
1.3.2 Class 5 indicators
16
1.3.3 Class 6 indicators
17
1.4 Process indicators for steam sterilisation processes
18
1.4.1 Double self-adhesive labels for printers with cutting device
18
1.4.2 Double self-adhesive labels for printers with split
19
1.4.4 Container label
21
1.4.5 Container seal
21
1.4.6.Autoclave tape
21
2.0 Indicators for ethylene oxide sterilisation processes
22
3.0 Indicators for formaldehyde sterilisation processes
23
4.0 Indicators for hydrogen peroxide sterilisation processes
24
5.0 Documentation System
26
5.1 Hand labelling devices
28
5.2 Single self-adhesive 3-line labels
28
5.3 Double self-adhesive 3-line labels
28
5.4 3-line eco documentation labels
29
6.0 Cleaning Indicators and Process Challenge Devices (PCDs)
31
6.1 Cleaning indicators for WDs
31
6.2 PCDs and cleaning indicator holder
31
6.3 Cleaning indicators for ultrasonic cleaning baths
32
3
1.
Chemical indicators to monitor steam sterilization processes
1.1
Bowie-Dick-Simulation Test
1.0 inChemical
to cheking
monitor
steam
sterilisation
process
used
vacuum steam Indicators
sterilization processes
leaks, non
condensable
gases (NCG) and/or
insufficient air removal and therefore sufficient steam penetration. The BDS indicator strip is placed into the BDStest device and sterilized in an empty chamber at 121°C, 15 min or 134°C, 3.5 min (BD-test program). Please
1.1 Bowie-Dick-Simulation Test
refer to the gke-colour reference chart for interpretation.
It is used in vacuum steam sterilisation processes checking leaks, non condensable gases (NCG)
insufficient
removal, and therefore insufficient steam penetration. The BDS indicator
1.1.1 and/or
Process
challengeairdevices
strip is placed into the BDS test device and sterilised in an empty chamber at 121°C, 15 min or
PENETRATION
AIR REMOVAL
134°C, 3.5 min (BD-testSTEAM
program).
Please refer to gke-colour reference chart (pg5)
for interpretation.
European Versions
1.1.1 ProcessEU-Version
Challenge Devices
Simulating 7 kg cotton pack according to
EN ISO 11140-4 and hollow load test
STEAM PENETRATION
according to EN 867-5
Art-Nr.
211-151 Compact-PCD® (blue)
EU-Version
Art-Nr. 211-150 Start-up kit, consisting of a
Simulating 7kg
cotton pack
(EN ISO 11140-4)
® (blue)
Compact-PCD
and
100 BDS-indicator strips
American Version
EU-Version
Simulationg 7 kg cotton pack
according to EN ISO 11140-4
STEAM PENETRATION
Art-Nr.
211-121 Compact-PCD® (purple)
EU-Version
Art-Nr. 211-120 Start-up kit, consisting of a
Simulating 7kg cotton®pack (EN ISO 11140-4)
Compact-PCD (purple) and
and hollow100
load
test (EN 867-5)
BDS-indicator
strips
USA-Version
Simulating 4 kg cotton pack
according to ISO 11140-5
AIR REMOVAL
Art-Nr.
211-131 Compact-PCD® (light blue)
USA-Version
Art-Nr. 211-120 Start-up kit, consisting of a
SimulatingCompact-PCD
4kg cotton® (light
packblue)
(ISO 11140-5)
and
100 BDS-indicator strips
Steri-Record® Bowie-Dick-Simulation
1.1.2 BDS-indicator strips
PCD
consists
of an external highly durable case containing
Application
are equal for all versions and are included in all BDS start-upThe
kits
and
refill packs.
an internal stainless steel tube connected to a capsule holding
The
Steri-Record® Bowie-Dick-Simulation (BDS) Test is used
the indicator. The highly durable PCD can be used for several
daily after start up as a functionality check (type test, no sterility
thousand applications. There is only one indicator strip required
test) for steam sterilisers. It has to be carried out in an empty
for each test. The same indicator strip is used in all three BDS
steriliser chamber. The BDS test is no substitution for routine
before sterilization
after successful sterilization
versions and is self- adhesive for attachment to daily records.
monitoring. For routine monitoring, class 5 or 6 indicators in each
load or Batch Monitoring Systems (BMS) validated according to
Refill packs Performance characteristics
the load configuration should be used.
standards EN 285 and AAMI/ANSI ST79 describe
Art.-No.
Product code The steriliser
Quantity
three different
type tests which have been developed by
Table top sterilisers meeting 211-111
EN 13060 type B do not require a
100
Bowie-Dick Test, but a hollow211-112
load type test prescribed
in
EN
867-5.
C-S-BDS-SV1
250
However some steriliser manufacturers
1. American 500
BD-Test
211-115 request the daily use of
®
a BDS-test during start-up. The Compact-PCD (colour: blue)
Air removal test meeting AAMI/ANSI ST79 (4kg test pack) and
validated to the test method of ISO 11140-1 + 5.
combines the BD- and hollow load test in one test.
Product description
All three
Steri-Record® BDS-Tests are class 2 indicators
ISO 11140-1 consisting of a “specific test load”
710-002meeting
EN V15EN01/2012
Process Challenge Device (PCD) and an “indicator system”
(indicator strip) inside.
4
2. European BD-Test
Air removal and steam penetration test validated to the test method
of EN ISO 11140-1 + 4 with reference
to the
7kg test
Seite
5 von
24 pack in EN 285.
3. Hollow load test
Described in EN 867-5 required as an additional type test in EN 285.
All
BDS-tests are class 2 indicators as described in EN ISO
11140-1.
offers three different BDS-Tests with the following
performance characteristics. The table below shows the conformity
of the
-BDS Tests.
GKE BDS-Tests
BD-Test EN285
(7kg test pack)
Hollow Load test
EN 867-5
Compact-PCD®
(colour blue)
8
8
Compact-PCD®
(colour purple)
8
Compact-PCD®
(colour light blue)
BD-Test AAMI/ANSI ST79
(4kg test pack)
8
All the above mentioned BDS-Tests can be used in BD test programs
at 134°C, 1-3.5 min or 121°C, 15-30 min. If these BD-cycles are not
available, a normal cycle of 134°C for up to 9 min may be used.
Benefits
• The innovative patented “multi-stage” design of the Compact-PCD®,
colour blue, simulates the porous Bowie-Dick cotton pack and
the Helix-Test.
• To be used in 134°C and 121°C-Bowie-Dick-Test programs listed
in EN 285 and EN ISO 11140-3. The test may also be used in
old sterilisers without Bowie-Dick Test programs, and longer
sterilisation times, without losing sensitivity.
• Simple application - the chemical indicator may be easily
removed and evaluated on completion of each cycle.
• Easy interpretation of the results due to the precise colour
change.
• Continuous reproducibility of the results.
Operation description
A
BD indicator strip has to be placed into the PTFE holder
of the Compact-PCD® and the cap has to be tightened. The test
device should be placed close to the bottom and near the door
of the chamber on a stainless steel tray into an empty steriliser
chamber. This test can be used in Bowie-Dick-Test programs at
132-134°C (270- 273°F); 1 - 3.5 min or 121°C (250 °F); 15 min.
If this BD-cycle is not available, a normal cycle of 132-134°C
for up to 9 min may be used without losing sensitivity. If all six
bars of the chemical indicator turn from yellow to black it is
an indication of sufficient steam penetration inside the PCD.
A positive result confirms that the steriliser is working to the
steriliser specifications.
• The graduated colour change of the indicator bars indicates
the magnitude of air removal and steam penetration inside the
steriliser and absence of non-condensable gases in the steam.
• Environmentally friendly, no unnecessary waste.
• Indicator strips can be disposed with household waste.
• The indicator colour chemistry is a nonreversible chemical
reaction and remains colour-fast over time.
• All chemical indicators are protected from bleeding by
a polymer binder and surface coating.
Sufficient temperature, time,
and steam penetration
• Cost-effective due to re-use of the PCD.
Insufficient air removal and
steam penetration
• The screw-cap consists of a highly thermal resistant material
and stainless steel sandwich construction that protects hands
from high temperatures.
Temperature achieved, but no
air removal, and no steam
penetration
• self-adhesive labels simplify recording with the
Steri-Record® documentation system (p 26).
Insufficient temperature, no air
removal, and no steam penetration
Steriliser program requirements
Depending on the steriliser BD-test program, the correct BDS-Test
has to be selected.
5
Ordering information
Each start-up kit contains one Compact-PCD® and 100 indicator strips, as well as a documentation
sheet to be copied before daily use. Test devices are available separately as well. The indicator
strips are available as refill packs and contain a sealing kit for the screw cap.
1.1.1.1. Air removal and steam penetration test validated to the test method of EN ISO 11140-4 + 1
Class 2 with reference to the 7kg test pack in EN 285, and the hollow load test exceeding the
requirements of EN 867-5
Order No.
Product Code
Quantity
Content
Application
211-150
Chemo-D-BDS-1-C-H-EU
Start-up kit
1 + 100
Compact-PCD® (colour: blue)
indicator strips
1
Compact-PCD® (colour: blue)
BDS air-removal and steam-penetration
test for hollow and solid instruments
and also porous loads.
211-151
Chemo-D-BDS-PCD-C-H-EU
1.1.1.2. Air removal and steam penetration test validated to the test method of EN ISO 11140-4 + 1
Class 2 with reference to the 7kg test pack in EN 285
Order No.
Product Code
Quantity
Content
Application
211-120
Chemo-D-BDS-1-C-P-EU
Start-up kit
1 + 100
Compact-PCD® (colour: purple)
indicator strips
1
Compact-PCD® (colour: purple)
BDS air-removal and steam-penetration
test for porous loads and solid
instruments (not recommended for
hollow instruments)
211-121
Chemo-D-BDS-PCD-C-P-EU
1.1.1.3. Air removal test meeting AAMI/ANSI ST79 (4kg test pack) and validated according to the test
method of ISO 11140-5 + 1 Class 2
Order No.
Product Code
Quantity
Content
211-130
Chemo-D-BDS-1-C-USA
1 + 100
Compact-PCD® (colour: light
blue) indicator strips
1
Compact-PCD® (colour: light
blue)
211-131
Chemo-D-BDS-PCD-C-USA
Application
BDS air-removal test for porous loads
1.1.2. BDS indicator strips
Indicator strip refill packs for all above mentioned BDS-Tests
Order No.
Product Code
211-111
211-112
211-115
6
Quantity
Content
Application
Integrating indicator strips,
1 seal kit
Refill pack with integrating indicator
strips for all gke BDS tests.
100
Chemo-D-BDS
250
500
STEAM
1.2 Process Monitoring System (PMS)
STEAM
1.2used inProcess
Monitoring
System
(PMS)sterilant penetration, leaks and/or non condensable gases (NCG)
To be
all sterilisation
processes to monitor
air removal,
in
each
EO
1.2 Process
(PMS)
tobMonitoring
e used in allSystem
sterilization
processes to monitor air removal, sterilant penetration, leaks
and/or non condensable gases (NCG) in each batch. The indicator strip is placed into the
tob e used
all sterilization
processes
monitor
airThe
removal,
sterilant
penetration,
leaks
batch. The indicator
strip isinplaced
into the process
challengetodevice
(PCD).
test device
is sterilised
together with
the load. Please refer
EO
process
challenge
device
(PCD).
The
test
device
is
sterilized
together
with
the
load.
FORM
and/or
nonforcondensable
to the
colour
charts
interpretation.gases (NCG) in each batch. The indicator strip is placed into the
STEAM
1.2 Please
Process to
Monitoring
System
(PMS)
-colour
charts
interpretation.
the gke
processrefer
challenge
device
(PCD).
Thefortest
device is sterilized together with the load.
FORM
tob e used in all sterilization processes to monitor air removal, sterilant penetration, leaks VH2O2
EO
Please
refer
to
the
gke
-colour
charts
for
interpretation.
1.2.1 Process
challenge
devices (Hollow
load test)
(for details see
pg 8-9)
and/or
non
condensable
gases (NCG)
in each
1.2.1 Process
challenge
devices
(Hollow
loadbatch.
test) The indicator strip is placed into the VH2O2
process challenge device (PCD). The test device is sterilized together with the load.
FORM
1.2.1 Process
challenge devices (Hollow load test)
Please refer to the gke-colour charts for interpretation.
VH2O2
1.2.1 Process challenge devices (Hollow load test)
Art.-No.
Content
Art.-No.
Content
211-253
Art.-No.
Content
211-254
Art.-No.
Content
Order No.
Content
Start-up kit, consisting of 1 Compact-
Order No.
Content
Start-up
kit, consisting of 1 Compact-PCD,
PCD,
round andof100
indicator strips
Start-up
kit, consisting
1 Compact-PCD,
Start-up
kit, consisting
of 1 Compact200-020
Compact-PCD,
colour:
211-253round,1and
100 indicator strips gren, round
211-253
oval and
100 indicator
211-254Start-up
Start-up
kit, consisting
1strips
Compact-PCD,
kit, consisting
of 1ofCompact-PCD,
200-024
1oval,
Compact-PCD,
colour:
green,
211-254
and 100 indicator strips oval
PCD, round and 100 indicator strips
oval and 100 indicator strips
Compact-PCD,Content
colour: green,
11Compact-PCD,
colour:
green,oval
oval
Start-up kit, consisting of 1 CompactStart-up kit, consisting of 1 Compact-PCD,
1.2.2211-253
ProcessPCD,
challenge
devices (Hollow load test211-254
according to EN
867-5)
round and 100 indicator strips
oval and 100 indicator strips
200-020
1 Compact-PCD,
gren,(Hollow
roundtest load
1 (for
Compact-PCD,
colour:
1.2.2
Process
challenge
devices
test200-024
according
EN
867-5)
1.2.2
Process
challenge
devicescolour:
(Hollow
load
described
in EN 867-5)to
details
see pg
10-11)green, oval
200-020
1 Compact-PCD,
colour:Content
green, round
Art.-No.
200-020
1 Compact-PCD,
colour:
gren, round
200-024
Art.-No.
200-024
1.2.2 Process challenge devices (Hollow load test according to EN 867-5)
Art.-No.
Content
Start-up kit, consisting of 1 CompactArt.-No.
Content
Order 211-263
No. Content
PCD, round and 100 indicator strips
Start-up kit, consisting of 1 Compact200-021
1 Compact-PCD,
colour:
orange, round
211-263
211-263
Start-up
kit, consisting
1 Compact-PCD,
PCD,
round andof100
indicator strips
round,
and
100
indicator
strips
Art.-No. 1 Compact-PCD, colour:
Contentorange, round
200-021
200-021
1
Compact-PCD,
colour:
orange,Process
round
Start-up
kit,
consisting
of 1 Compact1.2.3211-263
High-Demand-Hollow
Monitoring
PCD, round and 100 indicator strips
1.2.3200-021
High-Demand-Hollow
Process
Monitoring
1 Compact-PCD, colour:
orange, round
Art.-No.
Content
Start-up kit, consisting of 1 Compact-PCD,
211-264
Art.-No.
Content
Order No. Content
oval and 100 indicator strips
Start-up kit, consisting of 1 Compact-PCD,
200-026
Compact-PCD,
colour:oforange,
oval
211-264
211-264 1 Start-up
kit, consisting
1strips
Compact-PCD,
oval and
100 indicator
oval,
and
100
indicator
strips
Art.-No.
200-026
1 Compact-PCD, Content
colour: orange, oval
200-026
1 Compact-PCD,
colour:
oval
Start-up
kit, consisting
oforange,
1 Compact-PCD,
System
(HDH-PMS)
211-264
oval and 100 indicator strips
System
200-026 (HDH-PMS)
1 Compact-PCD, colour: orange, oval
1.2.3 High-Demand-Hollow Process Monitoring System (HDH-PMS) (for details see pg 12-13)
1.2.3 High-Demand-Hollow Process Monitoring System (HDH-PMS)
Art.-No.
200-029
Art.-No.
200-029
Art.-No.
200-029
Content
1Order
Compact-PCD,
colour: red, round
No. Content
Content
1200-026
Compact-PCD,
colour: red, colour:
round red, round
1 Compact-PCD,
Content
1 Compact-PCD, colour: red, round
710-002 EN V15 01/2012
Seite 6 von 24
710-002 EN V15 01/2012
Seite 6 von 24 7
®®
STEAM
1.2.1 Steri-Record
Steri-Record
Batch Monitoring
Monitoring System
(BMS)
Batch
System
(BMS)
for complex hollow and solid instruments and porous loads
for steam sterilization processes
STEAM
For simple hollow and solid instruments and porous loads
Application
Application
®
® monitoring systems (BMS) are
The
Steri-Record
batch
The
Steri-Record
batch monitoring systems
used
for
routine
monitoring
in steammonitoring
sterilisation processes
in
(BMS) are used for routine
of steam
each cycle to
detect insufficient
air removal,
leaks,
and/or
non
sterilisation
processes
in each cycle
to detect
insufficient
aircondensable
removal, leaks,
and/orinnon
condensable
(NCG)
gases (NCG)
steam.
Monitoringgases
temperature
inand
steam.
Monitoring
temperature
and
pressure
alone
does
pressure alone does not provide sufficient information
to
not provide sufficient information to prove steam
prove steam penetration. This BMS simulates the penetration
penetration. This BMS simulates the penetration
requirements ofofsimple
hollowhollow
devices,minimal
tubes, porous
loads,
requirements
complex
invasive
and solid(MIS)
instruments.
surgical
instruments, tubes, solid instruments,
and porous loads.
Performance characteristics
Performance
characteristics
BMS
is a class 2 indicator EN ISO 11140-1,
The
The
BMS of
is a aclass
2 indicator
(ENload”
ISO 11140-1),
consisting
of
consisting
“specific
test
(Process
Challenge
- PCD)
and “indicator
(indicator
strip).
aDevice
“specific test
load” (Process
Challengesystem”
Device - PCD)
and “indicator
The BMS is a hollow load test as described in EN
system”
strip). Bothhas
PCDs
are calibrated
with
the Bowie-Dick
867-5.(indicator
This standard
been
modified
into
the new
standard
ISObiological
11140-6
and inside
is covered
by EN
test
pack (EN EN
285) with
indicators
as a reference
using
285 (large sterilisers) and EN ISO 13060 (small sterilisers
the test method described in the German draft Standard DIN 58921.
type B) and fulfils the requirements in terms of air
However,
thisand
BMS is
less demanding
regarding
air removal
andbeen
steam
removal
steam
penetration.
This
test has
validated
by
an
accredited
laboratory
to
EN
ISO
17025
penetration than the hollow load test described in EN 867-5.
(a test report is available on request).
Product description
Product
description
®
The
Steri-Record® Compact-PCD
consists of an external
The
Steri-Record® Compact-PCD® (process chalplastic casing with an internal stainless steel tube and capsule
lenge device) consists of an external plastic casing with
thestainless
indicator. steel
Two BMS
with theholding
same the
anholding
internal
tubeversions
and capsule
performance
characteristics
indicator.
Two
PCDs withare
theavailable*:
same performance characteristics are available*:
Compact-PCD® ®with
a round
cross section
a stainless
� •Compact-PCD
with
a round
cross and
section
and a
steel bracket.
can be putItvertically
a loading
rack on
or placed
stainless
steelIt bracket.
can be on
put
vertically
a
loading
rackon
orthe
placed
horizontally on the bracket.
horizontally
bracket.
Compact-PCD® ®with
an an
ovaloval
crosscross
section
whichwhich
can be can
placed
� •Compact-PCD
with
section
horizontally
on the flat side
of the
typePCD.
of construction
be
placed horizontally
on the
flatPCD.
sideThis
of the
This
type
construction
a flat the
height
cm allows
with of
a flat
height of 2.5with
cm allows
PCDof
to2.5
be used
in table-top
the
PCD to
sterilisers
. be used in table-top sterilizers .
Operation
description
Operation
description
One
ofof
twotwo
indicator
stripsstrips
have to
depending
on the
One
indicator
hasbetoselected
be selected
according
to
the
program
used:
program used:
1. 134°C, 3.5 min or 121°C, 15 min (standard cycle) or
134°C,
18 min
(prion
1.2.134°C,
3.5 min
or 121°C,
15cycle)
min (standard cycle) or
all four
of thecycle)
chemical indicator turn from yellow
2.If134°C,
18 bars
min (prion
(standard cycle)/pink (prion cycle) to black it is an
indication of sufficient steam penetration inside the PCD.
If all four bars of the chemical indicator turn from yellow standard
This result ensures air removal and steam pene- tration
cycle)/pink
cycle)load
to black,
it is an
indication
of sufficient
into the(prion
whole
under
the
conditions
the steam
load
penetration
inside the PCD. This result confirms air removal and steam
configuration.
penetration into the whole load where the PCD is representing the
load configuration.
Both versions are re-usable and can be used for a
Both versionsnumber
are re-usable
and can be cycles.
used for a considerable
considerable
of sterilization
number of sterilisation cycles.
* The performance characteristics are identical in the test cycles required by
the standard. There can be small differences if using cycles that differ from
* the
The test
performance
cycles.characteristics are identical in the test cycles required by
the standard. There can be small differences if using cycles that differ from
the test cycles.
Sufficient
temperature,
time,
and
steam
Sufficient temperature,
time, and
steam
penetration
penetration
Insufficient
air removal
and steam
Insufficient air removal
and steam penetration
penetration
Temperature
achieved,
but
no air
Temperature achieved
but no air
removal
and no
removal
and no steam penetration
steam penetration
Insufficient temperature,
and no airand
removal
Insufficient
temperature,
noandair
no steam penetration
removal,
and no steam penetration
Colour change of standard indicator strips
8
Benefits
• Indicator strips for standard and prion sterilisation cycles are
available.
• Only the use of a BMS allows the monitoring of sterility inside
simple hollow instruments, tubes, and porous goods, which
is not provided by recording pressure, temperature, and steam
quality in the chamber and/or using exposed indicator strips.
• Cost effective, due to multiple use. Only one indicator strip is
required for each sterilisation process instead of one in each pack.
• All information relevant to the process is supplied on completion
of the process so that the user can release the batch without
opening the pack to check the internal packaging indicator.
• Easy interpretation of the results due to precise colour change.
• Reproducibility of the results
• Environmentally friendly: no unnecessary waste.
• The graduated colour change of the indicator bars confirms
the magnitude of air removal and steam penetration inside the
steriliser and the absence of non- condensable gases in the steam.
• The indicator colour chemistry is a non reversible chemical reaction
and remains colour-fast over time.
• All
chemical indicators are protected from bleeding by a
polymer binder and surface coating and can be disposed with
household waste.
•
self-adhesive labels simplify recording with the
Steri-Record®
documentation system.
• Choice between two versions of Compact-PCD® - ideal handling
for each chamber size and load.
• The screw-cap consists of a highly thermal resistant material and
stainless steel sandwich construction that protects hands from
high temperatures. The chemical indicator may be easily
removed and evaluated on completion of each cycle.
• The Compact-PCD® can be used for a considerable number of
cycles. All important parts are made of stainless steel or thermal
resistant polymers.
Ordering information
Each start-up kit contains a Compact-PCD® and 100 indicator strips for standard steam sterilisation
processes as well as a documentation sheet to be copied before daily use. All test devices are also
available separately. The indicator strips are available as refill packs for standard and prion steam
sterilisation processes and also contain a sealing kit for the screw cap.
Order No
Product code
211-253
Chemo-D-CH-1-C
211-254
Chemo-D-CH-1-OC
200-020
Chemo-D-CH-PCD-C
200-024
Chemo-D-CH-PCD-OC
Quantity
1+100
1
211-252
Chemo-D-CH-2,5
250
211-255
Chemo-D-CH-5
500
211-211
Chemo-D-CH-PP-1
100
211-212
Chemo-D-CH-PP-2,5
250
211-215
Chemo-D-CH-PP-5
500
Content
Stated Value
Compact-PCD® round cross
section (colour: green),
indicator strips
Compact-PCD oval cross
section (colour: green),
indicator strips
®
134°C, 3.5 min
121°C, 15 min
Compact-PCD® round cross
section (colour: green)
Application
Monitoring simple hollow devices,
porous loads and solid instruments
in steam sterilisation processes
Compact-PCD® oval cross
section (colour: green)
Refill pack indicator strips,
+1 sealing kit
134°C, 3.5 min
121°C, 15 min
Indicator strips for all BMS to be
used in standard cycles
134°C, 18 min
Indicator strips for all BMS to be
used in prion cycles
9
®
Steri-Record
Monitoring
System
(BMS)
STEAM
1.2.2
Steri-Record®Batch
Batch Monitoring
System
(BMS)
for complex hollow and solid instruments and porous loads
for steam sterilization processes
STEAM
For complex hollow and solid instruments and porous loads for steam sterilisation processes
Application
Application
®
® monitoring systems (BMS) are
The
Steri-Record
batch
The
Steri-Record
batch monitoring systems
used for are
routine
monitoring
of steammonitoring
sterilisation processes
in
(BMS)
used
for routine
of steam
sterilisation
in each cycle
to detect
insuffieach cycle toprocesses
detect insufficient
air removal,
leaks,
and/orcient
non
air
removal, leaks,
and/orinnon
condensable
(NCG)
condensable
gases (NCG)
steam.
Monitoring gases
temperature
in steam. Monitoring temperature and pressure alone does
and pressure alone does not provide sufficient information to
not provide sufficient information to prove steam
prove steam penetration.
BMS simulates
penetration
penetration.
This BMSThissimulates
the the
penetration
requirements
of
complex
hollow
minimal
invasive
surgical
requirements of complex hollow minimal invasive
surgical
(MIS) instruments,
solid and
instruments,
(MIS) instruments,
tubes, solid tubes,
instruments,
porous loads.
and porous loads.
Performance
characteristics
Performance
characteristics
The
is a class
EN ISO 11140-1,
consisting
of a
is 2
a indicator
class 2 indicator
EN ISO
11140-1,
The BMSBMS
consisting
of a(Process
“specific
test load”
Challenge
“specific
test load”
Challenge
Device(Process
- PCD) and
“indicator
Device - PCD) and “indicator system” (indicator strip).
system” (indicator strip). The BMS is a hollow load test as described in EN
The BMS is a hollow load test as described in EN
867-5.
This This
standard
has beenhas
modified
the new standard
EN ISO
867-5.
standard
beeninto
modified
into the
new
standard
EN
ISO
11140-6
and
is
covered
by
EN
11140-6 and is covered by EN 285 (large sterilisers) and EN ISO 13060
285 (large sterilisers) and EN ISO 13060 (small sterilisers
(small
typefulfils
B) and fulfils
requirements in
of airof
removal
typesterilisers
B) and
the the
requirements
interms
terms
air
removal
and steam
This test
has
been
and
steam penetration.
Thispenetration.
test has been validated
by an
accredited
validatedto by
an accredited
to ENon
ISO
17025
laboratory
EN ISO
17025 (a testlaboratory
report is available
request).
(a test report is available on request).
Product description
Product
description
®
The
Steri-Record® Compact-PCD
(process challenge device)
The
Steri-Record® Compact-PCD® (process chalconsists of an external plastic casing with an internal stainless
lenge device) consists of an external plastic casing with
tube and
capsulesteel
holding
theand
indicator.
Twoholding
PCDs with
ansteel
internal
stainless
tube
capsule
thethe
same performance
characteristics
are available*:
indicator.
Two PCDs
with the same
performance characteristics are available*:
Operation
description
Operation
description
One
indicator
to be selected
according
One
of of
twotwo
indicator
stripsstrips
has tohas
be selected
according
to the
to the program
used:
program
used:
®
Compact-PCD® with
a round
cross section
a stainless
�• Compact-PCD
with
a round
cross and
section
and a
stainless
steel
bracket.
can beon
put
vertically
a
steel bracket.
It can
be putItvertically
a loading
rack on
or placed
loading
rackonorthe
placed
horizontally on the bracket.
horizontally
bracket.
®
Compact-PCD® with
an an
ovaloval
crosscross
section
which which
can be placed
�• Compact-PCD
with
section
can
be
placed horizontally
onofthe
side
theof
PCD.
This
horizontally
on the flat side
theflat
PCD.
Thisoftype
construction
type
offlat
construction
a flatthe
height
of be
2.5used
cmin
allows
with a
height of 2.5with
cm allows
PCD to
table-top
the PCD to be used in table-top sterilizers .
sterilisers.
Both versions are re-usable and can be used for a
Both versionsnumber
are re-usable
and can be used
for a considerable
considerable
of sterilization
cycles.
number of sterilisation cycles.
* The performance characteristics are identical in the test cycles required by
the standard. There can be small differences if using cycles that differ from
the test cycles.
* The performance characteristics are identical in the test cycles required by
the standard. There can be small differences if using cycles that differ from
the test cycles.
1. 134°C, 3.5 min or 121°C, 15 min (standard cycle) or
134°C,
18 min
(prion
1.2.
134°C,
3.5 min
or 121°C,
15cycle)
min (standard cycle) or
all four
bars(prion
of thecycle)
chemical indicator turn from yellow
2.If134°C,
18 min
(standard cycle)/pink (prion cycle) to black it is an
indication of sufficient steam penetration inside the PCD.
IfThis
all four
bars of
the chemical
indicator
turn
from yellow
result
ensures
air removal
and
steam
pene- tration
(standard
(prion under
cycle) tothe
blackconditions
it is an indication
of
into thecycle)/pink
whole load
the load
configuration.
sufficient
steam penetration inside the PCD. This result ensures
air removal and steam penetration into the whole load under
the conditions the load configuration.
Sufficient
temperature,
time,
and
steam
Sufficient temperature,
time, and
steam
penetration
penetration
Insufficient
air removal
and steam
Insufficient air removal
and steam penetration
penetration
Temperature
achieved,
but
no air
Temperature achieved
but no air
removal
and no
removal
and no steam penetration
steam penetration
Insufficient temperature,
and no airand
removal
Insufficient
temperature,
noandair
no steam penetration
removal,
and no steam penetration
Colour change of standard indicator strips
10
Benefits
• Indicator strips for standard and prion sterilisation cycles are
available.
• Only the use of a BMS allows the monitoring of sterility inside
complex hollow instruments, tubes, and porous goods, which
is not provided by recording pressure, temperature, and steam
quality in the chamber and/or using exposed indicator strips.
• Cost effective due to multiple use. Only one indicator strip is
required for each sterilisation process instead of one in each pack.
• All information relevant to release the process is supplied on
completion of the process so that the user can release the batch
without opening the pack for the internal packaging indicator.
• Easy interpretation of the results due to precise colour change.
• Reproducibility of the results.
• Environmentally friendly: no unnecessary waste.
• The graduated colour change of the indicator bars confirms
the magnitude of air removal and steam penetration inside the
steriliser and the absence of non- condensable gases in the steam.
• The indicator colour chemistry is a non-reversible chemical
reaction and remains colour-fast over time.
• All
chemical indicators are protected from bleeding by a
polymer binder and surface coating and can be disposed off
with household waste.
•
self-adhesive labels simplify recording with the
Steri-Record® documentation system.
• Choice from two Compact-PCD® versions - ideal handling for all
chamber sizes and loads.
• The screw-cap consists of a highly thermal resistant material
and stainless steel sandwich construction that protects hands
from high temperatures. The indicator may be easily removed
and evaluated on completion of each cycle.
• The Compact-PCD® can be used for a large number of cycles.
All important parts are made of stainless steel or thermal
resistant polymers.
Ordering information
Each start-up kit contains a Compact-PCD® and 100 indicator strips for standard steam sterilisation
processes as well as a documentation sheet to be copied before daily use. All test devices are also
available separately. The indicator strips are available as refill packs for standard and prion steam
sterilization processes and also contain a sealing kit for the screw cap.
Order No
Product code
Quantity
211-263
Chemo-D-CH-1-C-HA
211-264
Chemo-D-CH-1-OC-HA
200-021
Chemo-D-CH-PCDC-HA
200-026
Chemo-D-CH-PCDOC-HA
211-252
Chemo-D-CH-2,5
250
211-255
Chemo-D-CH-5
500
1+100
1
211-211
Chemo-D-CH-PP-1
100
211-212
Chemo-D-CH-PP-2,5
250
211-215
Chemo-D-CH-PP-5
500
Content
Compact-PCD®
round cross section
(colour: orange),
indicator strips
Compact-PCD®
oval cross section
(colour: orange),
indicator strips
Stated Value
Application
134°C, 3.5 min
121°C, 15 min
Monitoring complex
hollow and solid
instruments and
porous loads in
steam sterilisation
processes based on
EN 867-5 hollow
load test
134°C, 3.5 min
121°C, 15 min
Indicator strips for
all BMS to be used
in standard cycles
134°C, 18 min
Indicator strips for
all BMS to be used
in prion cycles
Compact-PCD®
round cross section
(colour: orange)
Compact-PCD®
oval cross section
(colour: orange)
Refill pack of
indicator strips,
+1 sealing kit
11
1.2.3
Steri-Record® Batch Monitoring System
STEAM
For extremely complex instruments and tubes
Application
The
Steri-Record® High Demand Hollow Batch Monitoring System
(HDH-BMS) is used for routine monitoring procedures in steam,
ethylene oxide, formaldehyde, or hydrogen peroxide sterilisation
processes to detect insufficient air removal, leaks in all processes,
and non condensable gases (NCG) in the steam. The HDH-BMS is
designed to monitor the penetration characteristics at the most
difficult positions inside the sterilisation load, inside instruments.
Monitoring temperature and pressure alone does not provide
sufficient information to prove sterilant penetration. The HDH-BMS
simulates the penetration requirements of extremely complex
hollow minimal invasive surgical (MIS) instruments, tubes, solid
instruments, and porous loads.
Product description
The
Steri-Record® HDH-BMS consists of a process challenge
device (PCD) consisting of an external red plastic case with an
internal stainless steel tube and capsule holding the indicator.
The PCD can be put vertically on a loading rack or placed
horizontally on its bracket. It is re-usable for several thousand
sterilisation cycles. offers appropriately biological and chemical
indicators for the sterilisation processes mentioned above.
Performance characteristics
The HDH-BMS is a class 2 indicator (EN ISO 11140-1), consisting
of a “specific test load” (Process Challenge Device - PCD) and
12
“indicator system” (indicator strip) covering extremely high test
requirements.
The
-HDH-BMS is used for routine monitoring of extremely
complex instruments or long tubes, where the hollow load test
(EN 867-5) is not sufficient. The HDH test requires a steriliser
with extremely high air removal and penetration characteristics.
The technical-team supports you by comparing the requirements
of a test system with the load configuration.
The standards for large sterilisers (EN 285) as well as for small
table-top sterilisers (EN 13060, class B) require a hollow load test
as described in EN 867-5, as a type test*. This type test with its
high requirements for sterilisers concerning air removal and steam
penetration is quite often used as an adequate batch monitoring
system. The HDH-BMS considerably surpasses this requirement.
EN 867-5 describes a test cycle with 9 injections of steam to 950
mbar. In this test cycle the hollow load test will be successfully
penetrated, if a vacuum of 450 mbar is reached in between each
steam pulse.
To penetrate the
-HDH BMS successfully in the same test
cycle a vacuum of under 210 mbar is necessary.
* A hollow load test to EN 867-5 is available using the Compact-PCD®, orange. Order No. 200-021
(round construction) or order No. 200-026 (oval construction) devices.
this data is only available under laboratory conditions using a
reproducible process in a test steriliser designed to meet EN ISO
18472. All other parameters that affect the air removal and
steam penetration are strictly defined in such a program and
must remain unchanged in all test cycles. Under real sterilisation
conditions the differences in performance between the type test
in EN 867-5 and the HDH-BMS may change considerably because
day-to-day programs differ from the above mentioned test cycle.
Usually fewer, but deeper, vacuum cycles are used.
Benefits
• The HDH-BMS considerably surpasses the requirements of the
hollow load test of EN 867-5. Therefore the test is suitable to
monitor the sterility of extremely complex hollow instruments.
• The PCD is usable in steam, ethylene oxide, formaldehyde,
and hydrogen peroxide sterilisation processes with the correct
indicator strip.
• Easy interpretation of the results due to precise colour change.
• Reproducibility of the results.
• Cost effective due to multiple use. Only one indicator strip is
required for each sterilisation process instead of one in each pack.
• Only the use of a BMS allows the monitoring of sterility inside
extremely complex hollow instruments, tubes and porous goods,
which is not provided by recording pressure, temperature, and
steam quality in the chamber and/or using exposed indicator strips.
• All information relevant to the process is supplied on completion
of the process so that the user can release the batch without
opening the packs.
• Environmentally friendly: no unnecessary waste.
• The graduated colour change of the indicator bars confirms the
magnitude of air removal and penetration inside the steriliser.
• The indicator colour chemistry is a non reversible chemical
reaction and remains colour-fast over time.
•
self-adhesive labels simplify recording with the
Steri-Record® documentation system.
• All
chemical indicators are protected from bleeding by a
polymer binder and surface coating and can be disposed with
household waste.
• The screw-cap consists of a highly thermal resistant material
and stainless steel sandwich construction that protects hands
from high tem- peratures. The chemical indicator may be easily
removed and evaluated on completion of each cycle.
• The Compact-PCD® can be used for a considerable number of
cycles. All important parts are made of stainless steel or thermal
resistant polymers.
Order information
The process challenge device (PCD) is available separately. The indicator strips are available as refill packs
for standard and prion steam sterilisation processes and also contain a sealing kit for the screw cap.
Order No
Product Code
200-029
Chemo-D-CH-PCD-C-HDH 1
211-252
211-255
Chemo-D-CH
211-211
211-212
Qty.
250
500
Content
Application/Sterilization process
Compact-PCD® round
construction (red)
Batch monitoring system for extremely
complex instruments
Refill pack of indicators
+1 sealing kit
Steam (Standard program) Stated Value (SV) =
134°C, 3.5, 121°C, 15 min
100
Chemo-D-CH-PP
211-215
250
Steam (Prion program) SV = 134°C, 18 min
500
212-202
Chemo-E-CH
250
Ethylene oxide
213-203
Chemo-F-CH
250
Formaldehyde
214-203
Chemo-W-CH
250
Hydrogen peroxide/Plasma
13
1.2.4 Load validated process challenge devices
1.2.4 Load validated process challenge devices
Ophthalmic Instrument
Loads
1.2.4 Load Validated Process Challenge
Devices
Ophthalmic Instrument
Loads
(p15)
1.2.4
1.2.4 Load
Loadvalidated
validatedprocess
processchallenge
challengedevices
devices
(p15)
1.2.4
Load
validated
process
challenge
devices
Dental Instrument Loads
Dental Instrument Loads
Ophthalmic Instrument Loads
Ophthalmic Instrument Loads
(p15)
(p15)
Art.-No.
Content
Start-up
kit,
consisting
of
Ophthalmic Instrument
Loads
1 Compact-PCD, white
211-291
(Ophthal-BMS) and
Order No. Content
indicator
strips
211-291
Start-up100
kit, consisting
of 1
Compact-PCD,
200-091
1white
Compact-PCD,
white
(Ophthal-BMS) & colour:
100 indicator
strips
Dental Instrument
STEAM Loads
Dental Instrument Loads
STEAM
STEAM
STEAM
Tattoo Equipment Loads
Tattoo Equipment Loads
Art.-No.
Content
Art.-No.
Content
Start-up
kit,
consisting
of
Start-up
kit,
consisting of
Dental Instrument Loads
Tattoo Equipment Loads
1 Compact-PCD, yellow
1 Compact-PCD, black
211-281
211-271
Order No. and
Content
Order No. and
Content
(Tattoo-BMS)
Order No. Content (Dental-BMS)
Order No. Content
Order
No. strips
Content
Order
No. strips
Content
Start-up
kit,
consisting
of
Start-up
kit,
consis
100
indicator
100
indicator
211-281
Start-up kit, consisting of 1 Compact-PCD,
211-271
Start-up kit, consisting of 1 Compact-PCD,
Start-up
kit, consisting
of 1(Tattoo-BMS)
Start-up
kit, consis
1strips
Compact-PCD,
white
1 Compact-PCD,
yello
200-081 yellow
1 Compact-PCD,
colour:
yellow
200-071
Compact-PCD,
colour:
black
(Dental-BMS) & 100
indicator
black
& 100 indicator
strips
211-291
211-281 1 Compact-PCD, yello
1 (Ophthal-BMS)
Compact-PCD,
white
and
BMS) and
200-091
1 Compact-PCD, colour: white
200-081
1 Compact-PCD,
colour: yellow
200-071
1 Compact-PCD,
colour: black
211-291
211-281
(Ophthal-BMS)
and
BMS) andst
100
indicator strips
100 indicator
Order No.
Content
Order No.
Content
Order
No.
Content
100 indicator
strips
100 indicator
st
200-091
colour:
200-081
colo
Order No.
Content
Order No.
Content 1 Compact-PCD,
Order
No.white
Content 1 Compact-PCD,
Start-up kit, consisting of
Start-up
kit, consisting
of
Start-up
kit, consisting
of
200-091
1
Compact-PCD,
colour:
white
200-081
1
Compact-PCD,
colo
Start-up
kit, consisting
Start-up kit, consisting
of
Start-up
kit, consisting
1 Compact-PCD,
whiteof
Compact-PCD,
yellow (Dental1 Compact-PCD,
blackof
1.2.5
PMS-indicator
strips
for 11standard
steam
sterilization
processes
to be used
in
211-291 BMS-1 and
211-281
211-271
Compact-PCD,
white
Compact-PCD,
yellow
(Dental1
Compact-PCD,
black
(Ophthal-BMS) and
BMS) and
(Tattoo-BMS) and
211-291
211-281
211-271
(Ophthal-BMS)
and
BMS)
and
(Tattoo-BMS)
and
100 15
indicator
100 indicator strips
100-tests,
indicatorStated
strips
Value (SV) = 121°C,
minstrips
or 134°C, 3 min. and are
all gke
100 indicator strips
100 indicator strips
100 indicator strips
200-091
1 Compact-PCD, colour: white
200-081
1 Compact-PCD,
colour:
yellow
200-071
1
Compact-PCD,
colour:
black
1.2.5 colour:
BMS-yellow
and PMS-indicator
strips forcolour:
standard
200-091 induded
1 Compact-PCD,
whitekits and
200-081
200-071
1 Compact-PCD,
black steam
in all colour:
start-up
refill1 Compact-PCD,
packs.
1.2.5 BMS- and PMS-indicator strips for standard steam
all gke-tests,
StatedforValue
1.2.5 BMS- and PMS-indicator strips for standard steam sterilisation
processes
use in(SV)
all = 121°C,
-tests, 15 min o
all gke-tests, Stated Value (SV) = 121°C, 15 min o
in all
kits
and
Stated Value (SV) = 121°C, 15 min or 134°C, 3 min (induded
in start-up
all start-up
kits
andrefill
refillpacks).
packs).
in allsterilisation
start-up kitsprocesses
and refill packs).
1.2.5 BMSBMS- and
and PMS-indicator
PMS-indicator strips
strips for
for standard
standard steam
steam
for use
use in
in
1.2.5
sterilisation processes
for
all
gke-tests,
-tests, Stated
Stated Value
Value (SV)
(SV) == 121°C,
121°C, 15
15 min
min or
or 134°C,
134°C, 33 min
min (induded
(induded
Refillall
Packs
gke
beforekits
sterilization
after successful sterilization
in all
all start-up
start-up
and refill
packs).
in
packs).
Order No.
Product Code kits and refill
Quantity
211-252
C-S-PM-SV1
211-255
250
Art.-No.
211-252
211-255
500
Before sterilisation
Refill packs
Product code
Before sterilisation
Before sterilisation
Quantity
Refill packs
250
C-S-PM-SV1After successful sterilisation
Refill packs
500
Product code
Before sterilisation
After successful Art.-No.
sterilisation
Before sterilisation
After successful 211-252
sterilisation
Art.-No.
Product code
C-S-PM-SV1
211-252
211-255
C-S-PM-SV1
Refill packs
Refill packs
211-255to be used in
1.2.6 BMS- and PMS-indicator strips for prion
steam sterilization processes
Art.-No.
Product code
Quantity
Art.-No.
Product18
code
Quantity
Value (SV) = 134°C,
min
all gke-tets, Stated
211-252
250
1.2.6 BMS and PMS-indicator
strips for prionC-S-PM-SV1
steam
sterilisation
processes
for use instrips
all
-tests,
1.2.6
BMS and
PMS-indicator
for
prion steam ster
211-252
250
C-S-PM-SV1
211-255
500
1.2.6
BMS
and
PMS-indicator
strips
for
prion steam ster
211-255
500
Stated Value (SV) = 134°C, 18 min
gke-tets, Stated Value (SV) = 134°C, 18 min
gke-tets, Stated Value (SV) = 134°C, 18 min
1.2.6 BMS
BMS and PMS-indicator
PMS-indicator strips
strips for
for prion
prion steam
steam sterilisation
sterilisation processes
processes for
for use
use in
in all
all
1.2.6
Refill Packsand before
sterilization
after successful sterilization
gke-tets,
-tets, Stated
Stated
Value (SV)
(SV) == 134°C,
134°C, 18
18 min
min
gke
Value
Order No.
Product Code
Quantity
211-211
211-212
211-215
C-S-PM-SV2
250
Art.-No. 500
211-211
211-212
Before sterilisation
Before sterilisation
211-215
710-002 EN V15 01/2012
14
100
Order No.
Order No.
211-211
211-211
211-212
211-212
211-215
211-215
Refill packsBefore sterilisation
Before sterilisation
Before sterilisation
Product code
Quantity
Refill packs
100
Refill packs
sterilisation
C-S-PM-SV2After successful250
No.
Product code
After successful Order
sterilisation
After successful
sterilisation
500
Order No.
Product code
211-211
211-211
211-212
C-S-PM-SV2
Refill packs
Refill packs
211-212
C-S-PM-SV2
211-215
Product code
Quantity
211-215
Product code
Quantity
100
Seite 7 von 24
100
C-S-PM-SV2
250
C-S-PM-SV2
250
500
500
1.2.4 Steri-Record® Ophthal-BMS
Steri-Record® Ophthal-BMS
STEAM
Batch Monitoring System (BMS) for ophthalmology instruments in STEAM
Batch Monitoring System (BMS) for ophthalmology instruments in steam sterilisation processes
steam sterilisation processes
nnovative design
Innovative
design
A BMS
using the
advanced international
A BMS using the advanced international patented “multi-stage”
patented “multi-stage” technology
technology connecting different lengths and volumes simulates
connecting
different lengths and volumes
the
steam
penetration
characteristics of ophthalmology
simulates the
steam penetration
characteristics of ophthalmology
Cost-effective and environmentally friendly
Performance characteristics
Application
In contrast to conventional
systems the chemical
Cost-effective
and environmentally
friendlyindicator strip is
®
The
Steri-Record batch monitoring systems
BMS The
is aindicator
class 2 isindicator
EN ISO
11140-1,
theThe
only consumable.
self-adhesive
and can
be
consisting
of a “specific
test load”
(Process indicator
Challengestrip is
to conventional
systems
the chemical
(BMS) are used for routine monitoring of steam In contrast
adhered
on
a
documentation
sheet
after
sterilisation.
Device
- PCD) and
(indicator
strip).
consumable.
The“indicator
indicator system”
is self-adhesive
and
can be
sterilisation processes in each cycle to detect insuffi- cient the only
The BMS is a hollow load test as described in EN
air removal, leaks, and/or non condensable gases (NCG) adhered
on a This
documentation
sheet
after
sterilisation.
867-5.
standard has
been
modified
into the new
in steam. Monitoring temperature and pressure alone does
standard EN ISO 11140-6 and is covered by EN

Img.:
Steri-Record
Ophthal-BMS
not provide sufficient information
to prove
steam
285 (large sterilisers) and EN ISO 13060 (small sterilisers
type B) and fulfils the requirements in terms of air
penetration. This BMS simulates the penetration
removal and steam penetration. This test has been
requirements
of
complex
hollow
minimal
invasive
Application
Application
validated by an accredited laboratory to EN ISO 17025
surgical
(MIS) instruments, tubes, solid instruments, The successful
sterilisation
instrument
does not only
depend
sterilisation
processes
dueof
to an
inappropriate
construction
which
This Ophthal-BMS is used for routine monitoring of typical
(a test report
is available
on request).
and porous loads.
This Ophthal-BMS
is used for routine monitoring of typical
efficiency
of the
steriliserinside
program,
butareas
alsoand
on the
construction
steam
penetration
sealed
therefore
ophthalmologic loads in each cycle. The device is designed to on theprevents
Operation There
description
ophthalmologic
loads
in each cycle. The device is designed to
of theresults
instrument.
instruments
on cannot
the market
which cannot
Product
description
in non-sterility.are
These
instruments
be reprocessed
verify steam
penetration inside all typical ophthalmologic
verify steam penetration inside
all
typical
ophthalmologic
One ofwith
twothe
indicator
strips has
to be
selected according
®
®
be
sterilised
most
efficient
steam
sterilisation
processes
in steam sterilisation processes. Therefore it is required that the due
instruments.
The instruments
must be clean and
disinfected
The
Steri-Record
Compact-PCD
(process
chalto the program used:
instruments. The instruments must be clean and disinfected before
prevents
penetration
instruments construction
are validated which
according
to EN steam
ISO 17664
and a inside
beforedevice)
the sterilisation
The directions
for use of
lenge
consistsprocedure.
of an external
plastic casing
with to inappropriate
the sterilisation
procedure.
The tube
directions
for use of the
1.
134°C,
3.5 min or
121°C,
15 min (standard
or
areas
andistherefore
results
non-sterility.
Thesecycle)
instruments
anthe
internal
stainless
andsterilisation
capsule holding
the sealedverification
available from
theinmanufacturer.
manufacturer
shallsteel
specify
steam
processes.
2.
134°C,
18
min
(prion
cycle)
manufacturer
shall
specify
steam
sterilisation
processes.
indicator. Two PCDs with the same performance char- cannot be reprocessed in steam sterilisation processes. Therefore it
If all that
four the
barsinstruments
of the chemical
indicatoraccording
turn from to
yellow
acteristics are available*:
is required
are validated
EN ISO
Performance
Characteristics
Operational
description
Performance
Characteristics
(standard
cycle)/pink
(prion
cycle)
to
black
it
is an
®
17664
and
a
verification
is
available
from
the
manufacturer.
� Compact-PCD
with
a round
cross tube
section
and
a
Ifindication
all four barsofofsufficient
the chemical
indicator
turn from
yellow
black
load configuration
contains
a maximum
length
of 50cm.
steam
penetration
inside
thetoPCD.
The load The
configuration
contains
a maximum
tube
of
50 cm.
stainless
steel
bracket.
It can be
putlength
vertically
onsterilise.
a
This
result
ensures
air
removal
and
steam
penetration
it
is
an
indication
of
sufficient
steam
penetration
inside
the
PCD.
Long
lumened
devices
are
extremely
difficult
to
clean
and
Operational description
Long tubes
are extremely
critical
goods to on
be the
cleaned
and
loading
rack or placed
horizontally
bracket.
intoresult
the wholeairload
under
the conditions
the the
load
removal
and steam
penetration
into
In
most
cases
they
are
treated
as
disposables.
Assuming
that
to black
from yellow
turn
indicator
of the chemical
four barsensures
If allThis
sterilized as well. In most ®cases they are treated as disposables.
configuration.
� tubes
Compact-PCD
with
an
oval
cross
section
which
can
load underofthe
conditions
that the
PCD is representing
of more than 50 cm length are used as disposables and notit iswhole
inside thethePCD.
penetration
steam
sufficient
an indication
be
placed
horizontally
on the
of the
This
Assumingre-sterilised,
that
tubescomplex
of more
than
50 flat
cm side
length
arePCD.
used
configuration.
hollow
instruments
e.g. phaco
handas
pieces Thisload
ensures air removal and steam penetration into the whole
result
type
ofnot
construction
withcomplex
a flat height
of 2.5
cm allows
disposables
and
re-sterilised,
hollow
instruments
are
the
most
difficult
goods
to
be
sterilised.
These
instruments
load under the condition that the PCD is representing the load
the
PCD
to are
be used
in table-top
sterilizers
.sterilised.
e.g. phacohave
hand
pieces
the
most
difficult
goods
to
be
been used as a reference to configure the specification of configuration.
Sufficient
temperature,
time,
and
steam
These instruments
haveare
beenre-usable
used as aand
reference
to used
configure
Sufficient temperature,
time, and
steam
penetration
Both
canthebe
for
a
the versions
Ophthal-BMS.
As a test method
validation
procedure
penetration
the specification
of the
As a test method
considerable
number
ofOphthal-BMS.
cycles.
according to DIN
58921
issterilization
applied.
Insufficient
air removal
and
steam
penetration
Insufficient air removal
and
steam
penetration
steam
and
time,
Sufficient temperature,
the validation procedure according to DIN 58921 is applied.
* The performance characteristics are identical in the test cycles required by
The
successful
sterilisation
an instrument
doesthat
notdiffer
onlyfrom
depend
the standard.
There
can be small of
differences
if using cycles
the test cycles.
on the efficiency of the steriliser program, but also on the
construction of the instrument. There are instruments on the
market which cannot be sterilised with the most efficient steam
Ordering information
penetration
penetration
steam
andbut
air removal
Insufficient
Temperature
achieved,
no air
Temperature achieved
but no air
removal
and no
removal
and no steam penetration
steam penetration
Temperature achieved, but no air removal and no
Insufficient temperature,
and no airand
removal
Insufficient
temperature,
noandair
penetration
steam
no steam penetration
removal,
and no steam penetration
Insufficient temperature, no air removal and no
Colour change of standard indicator
penetration
steam strips
Each start-up kit contains one Compact-PCD® Ophthal-BMS and 100 indicator strips as well as a documentation
Order
No. before daily
Product
Code
Content
sheet to be
copied
use.
Test devices are available separately
as well. The indi- catorApplication
strips are available
as refill packs
without
test
devices
since
the
test
devices
can
be
used
for
thousands
of
sterilization
cycles. Sealing
®
211-291
Chemo-D-BMS-1-Ophthal Startup kit
1 Compact-PCD Ophthal-BMS
rings for the screw cap are included in each refill pack.
(colour: white), 100 indicator strips Monitoring ophthalmologic loads
200-091
Order No.
Chemo-D-BMS-Ophthal
Product
Code
211-252
Chemo-D-BMS-1-Ophthal
211-291
Startup kit Chemo-D-CH
211-255
200-091 Chemo-D-BMS-Ophthal
211-252
Chemo-D-CH
211-255
in steam sterilisation processes
1 Compact-PCD® Ophthal-BMS
Content
Application
(colour: white)
indicator strips,
1 Compact-PCD ® 250
Ophthal-BMS
2 sealing kits
Refill pack with indicator strips for
Monitoring
(colour: white),
the Ophthal-BMS
500
integrating
indicator
strips,
ophthalmologic
loads in
100 indicator strips
2 sealing kits
steam
1 Compact-PCD ® Ophthal-BMS
sterilization processes
(colour: white)
250 indicator strips,
2 sealing kits
500 integrating indicator strips,
2 sealing kits
Refill pack with
indicator strips for the
Ophthal-BMS
15
1.3 Pack monitoring indicators for steam sterilisation processes
STEAM
ring indicators
for
steam
sterilisation
processes
Pack monitoring indicators are used inside packs to monitor all relevant parameters of steam
STEAM
indicators are used inside packs to monitor all relevant parameters of steam sterilisation
sterilisation
This
typeand
of porous
indicator
should
only be used
solid and porous goods are sterilised.
type of indicator
should processes.
only be used
if solid
goods
are sterilised.
Pack ifmonitoring
Pack monitoring
only
provide
sterility information
at located.
the position
STEAMwhere
provide sterility
information atindicators
the position
inside
the chamber
where they are
The inside the chamber
1.3
Pack
monitoring
indicators
for
steam
sterilisation
processes
e packs isthey
absolutely
necessary
sterilisation processes
without
forced air removal
areifused
are located.
Theif application
inside packs
is absolutely
necessary
sterilisation processes without
Pack
monitoring
indicators
areused.
usedAllinside
packsindicators
to monitor
allthe
relevant
parameters of steam sterilisation
or a Process
Monitoring
System
cannot
be
gke
steam
fulfil
requirements
forced
air removal
are
used
andshould
a BDS-Test
a Process
Monitoring
System
used.
All
processes.
type
of 11140-1.
indicator
only beor
used
if solid and
porous goods
are cannot
sterilised.bePack
monitoring
indicators as
describedThis
in EN
ISO
steam
indicators
fulfil the
requirements
4, 5 or inside
6 indicators
as described
in EN
11140-1.
indicators
only provide
sterility
information of
at class
the position
the chamber
where they
areISO
located.
The
application
insidefor
packs
is absolutely
necessary
if sterilisation processes without forced air removal are used
monitoring
indicators
steam
sterilisation
processes
and a BDS-Test or a Process Monitoring System cannot be used. All gke steam indicators fulfil the requirements
of class 4, 5 or 6 indicators as described in EN ISO 11140-1.
Class
4 pack
monitoring
indicatorsfor
for steam
steam sterilisation
1.3.1 1.3.1
Class
4 pack
monitoring
indicators
sterilisationprocesses
processes
Order No.: 211-403, C-S-P-4-SV1 (available as a pack with 3,200 labels on indicator cards)
e sterilisation
After successful sterilisation
Order No.: 211-403, C-S-P-4-SV1
Beforeassterilisation
(available
a pack with 3,200 labels on indicator cards)
Before sterilisation
After successful sterilisation
After successful sterilisation
Order No.: 211-403,
C-S-P-4-SV1
monitoring indicators for steam sterilisation
processes
(available as a pack with 3,200 labels on indicator cards)
1.3.2 Class 5 pack monitoring indicators for steam sterilisation processes
Label dimension: 14 x 65 mm
1.3.2 Class 5 pack monitoring indicators for steam sterilisation processes
Label
dimension:
14 x 65 mm
Order No.
Product Code
Quantity
211-224
C-S-P-5-SV1
400
211-225
800
211-226
3200
Label
dimension:
14 x 65 mm
Before sterilisation
After successful sterilisation
Before sterilisation
Order No.
211-224
211-225
211-226
16
After successful sterilisation
Product code
Quantity
400
Before
sterilisation
C-S-P-5-SV1
800
3200
Order No.
211-224
211-225
211-226
Product code
C-S-P-5-SV1
After successful sterilisation
Quantity
400
800
3200
Labels with Class 5 indicators for steam sterilisation processes
Order
211 -230/
OrderNo:
No.:
211 -235
-230/ -235
Product
code:
C-S-P-5-78x48-SA-SV1
Product
code:
C-S-P-5-78x48-SA-SV1
Order No.:
211 -230/ -235
Label
dimension:
48 x 78
Label
dimension:
48mm
x 78 mm
Product
code:
C-S-P-5-78x48-SA-SV1
Quantity:
500
or
1,000
roll
Quantity:
500
orlabels
1,000onlabels
on roll
Label dimension: 48 x 78 mm
Quantity:
500 or 1,000 labels on roll
OrderNo:
No.:
Order
Product
Product
code:
Order No.:code:
Label
dimension:
dimension:
Product
code:
Quantity:
Quantity:
dimension:
Quantity:
211 -222
-220/ -222
211 -220/
C-S-P-5-58x35-SV1
C-S-P-5-58x35-SV1
Label
211 -220/ -222 Label
58 x 35
mm
58 x 35 mm
C-S-P-5-58x35-SV1
Label
200 labels
zig-zag folded
200
labels
zig-zag folded
58
x
35
mm
or 1,000
roll on roll
or labels
1,000onlabels
200 labels zig-zag folded
or 1,000 labels on roll
1.3.3 1.3.3
ClassClass
6 pack
monitoring
indicators
processes
6 pack
monitoring
indicatorsfor
forsteam
steamsterilisation
sterilisation processes
Label6dimension:
23 x 66 mm indicators for steam sterilisation processes
.3.3 Class
pack monitoring
For standard steam sterilisation processes
SV = 121°C,
min and 134°C,
3 min
For standard
steam15sterilisation
processes
For
steam
sterilisation
processes
SV standard
= 121°C,
15 min
and 134°C,
3 min
SV = 121°C, 15 min and 134°C, 3 min
For prion steam sterilisation
SV sterilisation
= 134°C, 18 min
Forprocesses
prion steam
Forprocesses
prion steam SV
sterilisation
processes
= 134°C,
18 min
SV = 134°C, 18 min
Label
dimension:
Label
23 x 66 mm
dimension:
23 x 66 mm
Before
After
successful
sterilisation
Before
After
Product
Code
successful
sterilisation
Order No.
211-241
211-242
211-243
Order No.
211-241
Order
No.
211-242
211-241
211-243
211-242
211-238
211-243
211-239
211-238
211-240
211-239
C-S-P-6-SV1 (Standard)
211-240
Before
After
successful
sterilisation
Before
After
Quantity
2000
500
250
Product code
Product
Code
successful
sterilisation
Order No.
211-238
Product code
C-S-P-6-SV1 (Standard)211-240
211-239
C-S-P-6-SV1 (Standard)
C-S-P-6-SV2 (Prion)
C-S-P-6-SV2 (Prion)
Quantity
C-S-P-6-SV2 (Prion)
2,000
Quantity
2,000500
500250
2502,000
2,000500
500250
Quantity
2000
500
250
250
17
1.4 Process
indicators forfor
steam
sterilisation
processes
1.4 Process
Indicators
Steam
Sterilisation
Process
1.4
Process
indicators
for steam
Usage
and colour
changesterilisation processes
STEAM
STEAM
STEAM
Usage and colour
change
Process
indicators are adhered to each sterilisation package and change their colour during the sterilisation
to
provide
indicate
if (attached)
the pack has to
passed
sterilisation package
process or and
not. Process
do notduring
give
ProcessUsage
indicators
are
adhered
eachthe
sterilisation
changeindicators
their colour
and colour
change
information about the quality of the sterilisation process.
Process indicators
sterilisationhas
package
and change
during the
sterilisation
the sterilisation
processare
to adhered
indicatetoifeach
the package
been exposed
totheir
the colour
sterilisation
process.
to
provide
indicate
if
the
pack
has
passed
the
sterilisation
process
or
not.
Process
indicators
do
not give
Process indicators
do not
give
information
about
the
quality After
of the
label
can
The label
can be
adhered
to sterilisation
packs
or pouches.
thesterilisation
pack has been process.
opened forThe
medical
treatment,
information
about
the
quality
of
the
sterilisation
process.
label can be packs
transferred
to the patient
documentation.
Due been
to the different
(alignment)
of the splits the
be adhered tothe
sterilisation
or pouches.
After
the pack has
openedlayout
for medical
treatment,
labels
can
be
separated
according
to
their
usage.
This
allows
specific
information
or
barcodes
to
be
documented
the label
transferred
to
the
patientpacks
documentation.
Due
topack
thehas
different
layout
(alignment)
Thecan
labelbe
can
be
adhered
to
sterilisation
or
pouches.
After
the
been
opened
for
medical
treatment,
separately in two different locations.
of the the
splits
thecan
labels
can be separated
according
to their
usage.
allows
specific
information
or the
label
be transferred
to the patient
documentation.
Due
to theThis
different
layout
(alignment)
of the splits
gke
process
indicators
for
steam
sterilisation
change
their
colour
from
blue
to
brown/black
as
shown:
All
labels
be separated according
to their
usage.
This allows
specificAll
information
or barcodes
to befor
documented
barcodes
to can
be documented
separately
in two
different
locations.
process
indicators
steam
separately
in twotheir
different
locations.
sterilisation
change
colour
from blue to brown/black as shown:
Before
sterilisation
sterilisation
sterilisation
change After
their colour
from blue to brown/black as shown:
All gke process indicators for steam
Before
sterilisation
After sterilisation
1.4.1. Double-adhesiveBefore
endless
label with steam
on roll with 3” core for printers with
sterilisation
Afterindicator
sterilisation
a cutting device (7 cm x 70 m)
After the information is printed and the label is cut to the required length it can be stuck to sterilisation packs or
pouches. After the pack has been opened for medical treatment, the label can be transferred to the patient
1.4.1.
Double-adhesive
endless
steam
indicator
withfor
3” printers
core forwith
printers
with
1.4.1. Double-adhesive
endless
label
with with
steam
indicator
on roll on
withroll
3” core
a cutting
documentation,
picture
B. label
adevice
cutting
device
(7 Order
cm xNo:70211-390,
m) C-S-L-1-70-DA
(7cm
x 70m)
the information
is printed
the
is cut length
to theitrequired
length
it can be stuck
topouches.
sterilisation packs or
After theAfter
information
is printed and
the labeland
is cut
to label
the required
can be stuck
to sterilisation
packs or
Afteropened
the pack
has been
opened
for can
medical
treatment,
thepatient
labeldocumentation,
can be transferred
After thepouches.
pack has been
for medical
treatment,
the label
be transferred
to the
picture to
B. the patient
documentation, picture B.
Picture A
Picture A
Picture A
Picture B
Picture
B
Picture B
Order No.: 211-390, C-S-L-1-70-DA
Order No.: 211-390, C-S-L-1-70-DA
18
labels
Printer
1.4.2.
labels
Printer
1.4.2.
labels
labels
Printer
Printer
1.4.2.
1.4.2.
1.4.2.
Printer
labels
Other
label.
each
between
aa perforation
have
and
aa 33aa””3core
with
rolls
on
Other
available
are
label.
each
labels
between
self-adhesive
Other
Other
perforation
double
label.
label.
Theo
have
each
each
core
3core
between
between
with
rolls
perforation
aa perforation
on
have
have
and
and
available
are
”” core
labels
with
with
rolls
rolls
on
self-adhesive
available
available
double
areare
Theo
labels
self-adhesive
self-adhesive
double
double
The
double
self-adhesivelabels
labels
are
available
on on
rolls
with
a 3”
core and
have
aand
perforation
between
each
label. Other
cores
and
number
Theo
Theo
demand.
on
manufactured
be
can
roll
per
label
of
number
and
cores
demand.
on
manufactured
be
can
roll
demand.
demand.
per
onon
label
ofbelabel
number
manufactured
manufactured
bedemand.
be
and
can
can
cores
rollroll
of
label
per
roll of
can
manufactured
on
Two different
label
sizes of 35 x 58 and 35 x 78 mm (800 labels per roll) are available
perper
label
of
number
number
and
and
cores
cores
labels
Printer
1.4.2.
labels
Printer
1.4.2.
with
options of
either no split (corner split), middle split, or bottom split.
Other
label.
each
between
perforation
aare
have
and
no
3a”(800
either
a(800
of
options
rolls
on
with
Other
available
are35
label.
roll)
each
labels
per
between
self-adhesive
mm
perforation
double
78
a are
xxrolls
35
Theo
have
and
and
no
58
xxavailable
core
”labels
3core
either
of
of
with
sizes
options
label
on
with
different
available
nono
Two
are
are
either
either
roll)
of
of
labels
per
options
options
labels
with
with
self-adhesive
(800
mm
78
available
available
are
35
Theo double
roll)
roll)
and
per
per
58
35
labels
labels
ofavailable
(800
sizes
mm
mm
label
78
78
xxwith
35
35
different
and
and
58
Two
xx 58
35
35
of
of
sizes
sizes
label
label
different
different
Two
Two
demand.
manufactured
be
can
rollroll
per
label
ofsplit),
number
and
cores
split.
bottom
or
demand.
split,
middle
manufactured
(corner
can
split
per
label
of
number
and
cores
split.onon
bottom
or
split,
middle
split),
split.
split.
(corner
bottom
bottom
split
orbeor
split,
split,
middle
middle
split),
split),
(corner
(corner
split
split
with options of either no
available
areare
roll)
perper
labels
(800
mm
x 78
3535
and
x 58
3535
of of
sizes
label
different
available with options of either no
Two
roll)
labels
(800
mm
x 78
and
x 58
sizes
label
different
Two
split
Corner
1.4.2.1.
split
Corner
1.4.2.1.
split
split
Corner
Corner
1.4.2.1.
1.4.2.1.
middle split, or bottom split.
1.4.2.1. Corner split
split),
(corner
split
split), middle split, or bottom split.
(corner
split
1.4.2.1.
split
Cornersplit
1.4.2.1. Corner
Corner
Split
CornerCornerCornerCornerOrder No: 211-342, C-S-L-1-60x40-SC-DA
C-DA
C-S-L-1-60x40-S
211-342,
No.:
Order
C-DA
C-S-L-1-60x40-S
211-342,
No.:
C-DA
C-DA
Order
C-S-L-1-60x40-S
C-S-L-1-60x40-S
211-342,
211-342,
No.:
No.:
Order
Order
Order No.: 211-342, C-S-L-1-60x40-SC-DA
SplitSplit
Split
Split
CornerCornerSplit
Split
C-S-L-1-60x40-SC-DA
No.: 211-342,
Order
split
Centre
1.4.2.2.
split
Centre
1.4.2.2.
split
split
Centre
Centre
1.4.2.2.
1.4.2.2.
1.4.2.2. Centre split
Order No: 211-346,
C-S-L-1-80x40-SC-DA
211-346, C-S-L-1-80x40-SC-DA
Order No.:
C-DA
C-S-L-1-80x40-S
211-346,
No.:
C-DA
C-DA
Order
C-S-L-1-80x40-S
C-S-L-1-80x40-S
211-346,
211-346,
No.:
No.:
Order
Order
C-DA
C-S-L-1-80x40-S
211-346,
No.:
Order
C-DA
C-S-L-1-80x40-S
211-346,
No.:
Order
1.4.2.2.
split
Centresplit
1.4.2.2. Centre
Split
Center
Centre
Split
Split
Center
Split
Split
Center
Center
Split
Center
Split
Center
Order No.: 211-347, C-S-L-1-80x40-SM-DA
M-DA
C-S-L-1-60x40-S
211-343,
No.:
Order
M-DA
Order
No:
211-343,
C-S-L-1-60x40-SM-DA
C-S-L-1-60x40-S
211-343,
No.:
M-DA
M-DA
Order
C-S-L-1-60x40-S
C-S-L-1-60x40-S
211-343,
211-343,
No.:
No.:
Order
Order
SM-DA
C-S-L-1-80x40211-347,
No.:
Order
SM-DA
SM-DA
C-S-L-1-80x40C-S-L-1-80x40211-347,
211-347,
No.:
No.:
Order
Order
Order No: 211-347,
C-S-L-1-80x40-SM-DA
(10mm)
Split
Bottom
1.4.2.3.
M-DA
C-S-L-1-60x40-S
211-343,
No.:
Order
(10mm)
Split
Bottom
1.4.2.3.
(10mm)
(10mm)
Split
Split
M-DA
Bottom
Bottom
C-S-L-1-60x40-S
1.4.2.3.
1.4.2.3.
211-343,
No.:
Order
SM-DA
C-S-L-1-80x40211-347,
No.:
Order
SM-DA
C-S-L-1-80x40211-347,
No.:
Order
1.4.2.3.Bottom
Bottom
Split
(10mm)
1.4.2.3.
(10mm)
Split(10mm)
BottomSplit
1.4.2.3.
SplitSplit
Split
Split
fromfrom
10 mm
mm
10
from
from
mmmm
10 10
bottom
bottom
bottom
bottom
U-DA
C-S-L-1-60x40-S
211-344,
No.:
Order
U-DA
C-S-L-1-60x40-S
211-344,
No.:
U-DA
U-DA
Order
C-S-L-1-60x40-S
C-S-L-1-60x40-S
211-344,
211-344,
No.:
No.:
Order
Order
U-DA
C-S-L-1-60x40-S
211-344,
No.:
Order
Order
No:
211-344,
C-S-L-1-60x40-SU-DA
U-DA
C-S-L-1-60x40-S
211-344,
No.:
Order
Split 10mm
Split
Split
from
bottom
from
mm
10 10
from
mm
bottom
bottom
SU-DA
C-S-L-1-80x40211-348,
No.:
Order
SU-DA
C-S-L-1-80x40211-348,
No.:
Order
SU-DA
SU-DA
C-S-L-1-80x40C-S-L-1-80x40211-348,
211-348,
No.:
No.:
Order
Order
SU-DA
C-S-L-1-80x40211-348,
No.:
Order
C-S-L-1-80x40-SU-DA
211-348,
No.:
Order
Order No: 211-348,
C-S-L-1-80x40-SU-DA
19
.2.4. Bottom
split
mm)
1.4.2.4.
(16 mm) Order No: 211-373 C-S-L-1-80x50-W-SU-DA
4.2.4.
BottomBottom
split(16
(16split
mm)
The
double
self-adhesive
label sized
x 78 48
mmxare
a roll withon
a 3”
corewith
and a
750
have a horizontal split
double
self-adhesive
label48
sized
78available
mm areon
available
a roll
3”labels.
core The
andlabels
750 labels.
4.2.4. Theo
Bottom
split
(16
mm)
Theo
double
self-adhesive
label sized 48 x 78 mm are available on a roll with a 3” core and 750 labels.
16
mm
from
the
bottom
of
the
label.
The
labels
have
a horizontallabel
split 16 mm48from
bottom
of the label.
Theo
double
self-adhesive
x 78the
mm
are available
on a roll with a 3” core and 750 labels.
The
labels
have
a horizontal splitsized
16 mm from
the
bottom
of the label.
The labels have a horizontal split 16 mm from the bottom of the label.
Art.-No.: 211-373
Art.-No.: 211-373
C-S-L-1-80x50-W-SU-DA
Art.-No.: 211-373
C-S-L-1-80x50-W-SU-DA
C-S-L-1-80x50-W-SU-DA
Split 16mm
Split 16 mm
Splitbottom
16 mm
from bottom
from
from
Split bottom
16 mm
from bottom
.2.5. Getinge
4.2.5.
Getingedocumentation
documentationsystem
systemlabel
label
This
perforated
double
self-adhesive
label
(56 xlabel
102 mm) on
a roll withC-S-L-1-SL-DDOC
a 3” core and three
4.2.5. 1.4.2.5.
Getinge
documentation
system
label
Getinge
documentation
system
This perforated double self-adhesive label
(56 x 102 Order
mm) No:
on 211-370
a roll with a 3” core and three
segments/splits
for
computerized
documentation
the
Getinge
documentation
This
double
self-adhesive
label
(56
x 102
mm)
on abe
rollused
with
3”
and
segments/splits
computerised
Thisperforated
perforated
double
self-adhesive
label
(56
x can
102
mm)
on awith
awith
rollcore
with
a three
3” core
and three forsystem.
segments/splits
for
computerized
documentation
can
be
used
the
Getinge
documentation
system.
documentation
canfor
be used
with the Getinge
documentation
segments/splits
computerized
documentation
cansystem.
be used with the Getinge documentation system.
Art.-No.: 211-370
Art.-No.: 211-370
C-S-L-1-SL-DDOC
Art.-No.: 211-370
C-S-L-1-SL-DDOC
C-S-L-1-SL-DDOC
Horizontal split
Horizontal split
Horizontal
split
Horizontal
split
Vertical Split
Vertical Split
Vertical Split
.3. Single
4.3.
Singleself-adhesive
self-adhesivedata
datalabel
label
labels
(48
x 78 mm) are
available
onlabel
a roll with aNo:3“211-382
core (1,000
labels/roll) with perforation between each
4.3. Theo
Single
self-adhesive
data
label
1.4.3.
Single
data
C-S-L-1-80x50-WF-SA
Theo
labels
(48 x 78self-adhesive
mm) are
available
on a rollOrder
with a 3“ core (1,000
labels/roll) with perforation between each
label.
labels(48
(48xx 78
78 mm)
on on
a roll
a 3“ core
labels/roll)
with perforation
between each
label. each
TheoThe
labels
mm)are
areavailable
available
a with
roll with
a 3“(1,000
core (1,000
labels/roll)
with perforation
between
label.
label.
Art.-No.: 211-382
Art.-No.: 211-382
C-S-L-1-80x50-WF-SA
Art.-No.: 211-382
C-S-L-1-80x50-WF-SA
C-S-L-1-80x50-WF-SA
20
.4. Self-adhesive container label
The self-adhesive container labels (60 x 38 mm) are available on a roll with a 3“ core (1,000 labels/roll) with
ve
label
4.4.container
Self-adhesive
container
label
perforations
between
each label.
Before use the label can be written on manually or by a printer and then put
sive
container
labels
(60container
xor38applied
mm)labels
are
available
a roll
with
3“ core
labels/roll)
Thepacks,
self-adhesive
(60 x 38on
mm)
are
available
on a(1,000
roll with
a 3“ corewith
(1,000
labels/roll)
with
er label
into
pouches,
to containers
which
have
toasterilised.
After
sterilisation
they
are stuck
onto the
etween
each
label.
Before
use
the
label
can
be
written
on
manually
or
by
a
printer
and
then
put
perforations
between
each
label.
Before
use
the
labelC-S-L-1-CL-40x60-SA
can be written
r labels
(60
xdocumentation
38Self-adhesive
mm)
are available
on
a rolllabel
with Order
a 3“
core
(1,000
labels/roll)
with on manually or by a printer and then put
1.4.4.
container
No:
211-341,
patient
sheet.
uches,
or
applied
to
containers
which
have
to
sterilised.
After
sterilisation
they
aresterilisation
stuck
the
The
self-adhesive
container
labels
(60 on
xto38containers
mm) are available
ahave
roll with
3“ core
labels/roll)
withonto
perforations
between
each
label. into
Before
use the
label
canorbeapplied
written
manually
or by
a on
printer
and
put(1,000
packs,
pouches,
which
toathen
sterilised.
After
they are
stuck
onto the
label.
Before
use
the
label
can
be
written
on
manually
or
by
a
printer
and
then
put
into
packs,
pouches,
or
applied
to
containers
which
entation
sheet.
plied
topatient
containers
which have to sheet.
sterilised. After sterilisation they are stuck onto the
documentation
et.
have to sterilised. After sterilisation they are stuck onto the patient documentation sheet.
Order No.: 211-341, C-S-L-1-CL-40x60-SA
Order No.: 211-341, C-S-L-1-CL-40x60-SA
Order No.: 211-341, C-S-L-1-CL-40x60-SA
.5. 22)
Container seal (see page Order
22) No.: 211-341, C-S-L-1-CL-40x60-SA
age
adhesive
seal with
a process
indicator
rocessThe
indicator
can secure
containers
and has
space tocan
sticksecure
a 3-linecontainers
label (see and has space to stick a 3-line label (see
1.4.5.
Container
seal Order
No: 211-362,
C-S-L-1-CS
eal (see
page
22)
4.5.
Container
seal
(see
page
22)
section
5, pp26 ff)with a process indicator can secure containers and has space to stick a 3-line label
Theprocess
adhesive seal
seal with
indicator
secureindicator
containers
has space
to stick
3-line
labelto(see
Theaadhesive
seal with can
a process
canand
secure
containers
anda has
space
stick a 3-line label (see
6 ff) section 5, pp26 ff)
Art.-No.: 211-362, C-S-L-1-CS
Art.-No.: 211-362, C-S-L-1-CS
ss indicator to seal packs,
in rolls of211-362,
50 m length
and 19 mm
width. C-S-L-1-CS
Art.-No.:
C-S-L-1-CS
Art.-No.:
211-362,
.6. Autoclave tape
Adhesive tape with a process indicator to seal packs, in rolls of 50 m length and 19 mm width.
ape Autoclave
1.4.6. Autoclave
4.6.
tape tape Order No.: 211-351, C-S-L-1-AT
Adhesiveindicator
tape with a to
toin
seal
packs,
in50
rolls
oflength
50 m length
width.
with aAdhesive
process
sealindicator
packs,
rolls
m
19
tape
with process
a process
indicator
toofseal
packs,
in and
rollsand
of19mm
50mm
mwidth.
length and 19 mm width.
on
After passing through sterilisation process
Order No.: 211-351, C-S-L-1-AT
Before sterilisation
Before sterilisation
re sterilisation
Before sterilisation
After passing through sterilisation process
After passing through sterilisation process
After passing
through
sterilisation
process
After
passing through
sterilisation process
Order
No.: 211-351,
C-S-L-1-AT
Order No.: 211-351,Order
C-S-L-1-AT
No.: 211-351, C-S-L-1-AT
21
2.0
2.0
Chemical
indicators
to
ethylene
oxide
(EO)
processes
2.0
Chemical
indicators
to monitor
ethylene
(EO) sterilisation
processes EO
Chemical
indicators
to monitor
monitor
ethylene
oxideoxide
(EO) sterilisation
sterilisation
processes
EO
EO
02.0
Chemical
indicators
todevice
to
monitor
monitor
ethylene
ethylene
oxide
oxide
(EO)
(EO)
sterilisation
sterilisation
processes
processes
P
challenge
(PCD)
2.1
Process
rocessindicators
challenge
device
(PCD)
2.1 Chemical
2.1
Process
challenge device
(PCD)
Used
in
sterilisation
indicator
oxide (EO)
Used sterilisation
in ethylene
ethylene oxide
oxideprocesses
sterilisation processes
processes to
to monitor
monitor the
the efficiency
efficiency of
of EO-gas
EO-gas in
in each
each batch.
batch. The
The
indicator
EO
EO
Used in ethylene oxide sterilisation processes to monitor the efficiency of EO-gas in each batch. The indicator strip is placed into
the
Pstrip
rocess
challenge
challenge
device
device
(PCD)
(PCD)
12.1 Process
is
placed
into
the
PCD.
The
test
device
is
sterilized
together
with
other
packages
and
containers.
strip
is
placed
into
the
PCD.
The
test
device
is
sterilized
together
with
other
packages
and
containers.
PCD. The test device is sterilised together with other packages and containers.
EOto monitor
Used
Used
in ethylene
in ethylene
oxide
oxide
sterilisation
sterilisation
processes
processes
to monitor
thethe
efficiency
efficiency
of EO-gas
of EO-gas
in each
in each
batch.
batch.
TheThe
indicator
indicator
strip
strip
is placed
is placed
into
thethe
PCD.
TheThe
testtest
device
device
is sterilized
is sterilized
together
together
withwith
other
other
packages
packages
andand
containers.
containers.
onitor the
efficiency
ofinto
EO-gas
inPCD.
each
batch.
The
indicator
ilized together with other packages and containers.
Order No.
Product code
Quantity
Quantity
11 ++ 200
200
(Start-up
kit,of
consisting
212-250
C-E-PM-HPCD-KIT
1+200 (Start up kit
consiting
1 PCD
212-250
C-E-PM-HPCD-KIT
(Start-up
kit,
consisting
Order
Order
No.
No.
Product
Product
code
code
Quantity
Quantity
212-250
C-E-PM-HPCD-KIT
of 1 PCD and
and 200 indicator strips
of 1 PCD and
200
1 +indicator
1200
+ 200strips)
200 indicator strips)
200-028
C-E-PM-HPCD
1 (Single PCD)
(Start-up
(Start-up
kit,
consisting
kit, consisting
200-028
C-E-PM-HPCD
11 (single
PCD)
212-250
212-250
C-E-PM-HPCD-KIT
200-028 C-E-PM-HPCD-KIT
C-E-PM-HPCD
(single PCD)
Order
ProductQuantity
code
Order
No. No.
Product Code
Order No.
212-250
200-028
2.2
2.2
Product code
C-E-PM-HPCD-KIT
C-E-PM-HPCD
Quantity
1 + 200
(Start-up kit, consisting
of 1 PCD and
200 indicator strips)
200-028
200-028
C-E-PM-HPCD
C-E-PM-HPCD
of 1 of
PCD
1 PCD
and and
200 200
indicator
indicator
strips)
strips)
1 (single
1 (single
PCD)PCD)
1 (single PCD)
Indicator
Indicator strips
strips for
for ethylene
ethylene oxide
oxide sterilisation
sterilisation processes
processes
2.2 Indicator strips for ethylene oxide sterilisation processes
The indicator strips can be used in the PCD above. A successful sterilisation is indicated by a colour change
change
22.2 Indicator
Indicator
forfor
ethylene
ethylene
oxide
oxide
sterilisation
sterilisation
processes
processes
from
to
green.
from blue
bluestrips
tostrips
green.
The
The
indicator
indicator
strips
strips
cancan
be be
used
used
in the
in the
PCD
PCD
above.
above.
A successful
A successful
sterilisation
sterilisation
is indicated
is indicated
by by
a colour
a colour
change
change
sation
processes
from
from
blue
blue
to green.
to green.is indicated by a colour change
. A successful
sterilisation
Theindicator
indicator
strips
used
the APCD
above.
A successful
sterilisation
is indicated
a colour
The
strips
can becan
usedbe
in the
PCDin
above.
successful
sterilisation
is indicated
by a colour change
from blueby
to green.
Order No.
Before sterilisation
Before
Before sterilisation
sterilisation
Before
Before
sterilisation
sterilisation
After successful sterilisation Order
Order No.
No.
After successful sterilisation
212-202
After
212-202
After
Product Code
Quantity
successful
C-E-PM sterilisation
250
successful
sterilisation
Refill
Refill packs
packs After
After
successful
successful
sterilisation
sterilisation
Product code
Product
code
Refill
Refill
packs
packs
C-E-PM
Quantity
Quantity
250
250
Quantity
Quantity
250250
212-202
C-E-PM
Order
Order
No.No.
Product
Product
code
code
2.3 Self-adhesive package monitoring indicator
212-202
212-202
C-E-PM
C-E-PM
2.3
Self-adhesive
package
monitoring
indicator
Self-adhesive
package
monitoring
indicator
No: 212-206,
C-E-P-5-58x35-W-SV3
(Label dimension:
58x35mm available as package with 200 labels - Zig Zag Folded)
ct2.3
code Order
Quantity
-PM
250
packs
32.3 Self-adhesive
Self-adhesive
package
package
monitoring
monitoring
indicator
indicator
ator
Order No: 212-206, C-E-P-5-58x35-W-SV3
Label dimension: 58 x 35 mm
Order
Order No:
No: 212-206,
212-206, C-E-P-5-58x35-W-SV3
C-E-P-5-58x35-W-SV3
Label
dimension:
Label dimension: 58
58 xx 35
35 mm
mm
Order
Order
No:No:
212-206,
212-206,
C-E-P-5-58x35-W-SV3
C-E-P-5-58x35-W-SV3
Available
package
with
(zig-zag-folded)
Label
Label
dimension:
dimension:
58labels
58
x 35
x 35
mm
mm
Available as
as
package
with 200
200
labels
(zig-zag-folded)
Available
Available
as as
package
package
with
with
200200
labels
labels
(zig-zag-folded)
(zig-zag-folded)
lass
monitoring
indicators
2.4
Cpackage
lass 44 package
package
monitoring
indicators for
for ethylene
ethylene oxide
oxide sterilisation
sterilisation processes
processes
2.4 asC
ailable
with 200 labels
(zig-zag-folded)
2.4 Class 4 package monitoring indicators for ethylene oxide sterilisation processes
C-E-P-4-SV3
(available indicators
as package
with 3,200
labels
on indicator
cards)sterilisation
COrder
lass
4No:package
4212-360,
package
monitoring
monitoring
indicators
forfor
ethylene
ethylene
oxide
oxide
sterilisation
processes
processes
42.4 Class
or ethylene oxide sterilisation processes
Before
Before sterilisation
sterilisation
Before sterilisation
After
After successful
successful sterilisation
sterilisation
After successful sterilisation
Before
Before
sterilisation
sterilisation Order
After
After
successful
successful
sterilisation
sterilisation
Order No:
No: 212-360,
212-360, C-E-P-4-SV3
C-E-P-4-SV3
(available
as
package
with
3,200
labels
on
indicator
cards)
(available
as package with 3,200 labels on indicator cards)
After successful
sterilisation
Order
Order
No:No:
212-360,
212-360,
C-E-P-4-SV3
C-E-P-4-SV3
22
(available
(available
as as
package
package
withwith
3,200
3,200
labels
labels
on on
indicator
indicator
cards)
cards)
360, C-E-P-4-SV3
3.0 Chemical indicators to monitor formaldehyde sterilisation processes
3.0
Chemical
indicators
to
formaldehyde
sterilisation
processes
to monitor
formaldehyde
sterilisation
processes
0indicators
3.0Chemical
Chemical
indicators
indicators
to monitor
tomonitor
monitor
formaldehyde
formaldehyde
sterilisation
sterilisation
processes
processes
3.0 Chemical indicators to monitor formaldehyde sterilisation processes
FORM
FORM
3.1
Process
challengedevice
device (PCD)
(PCD)
FORM
FORM
P
rocess
challenge
3.1
FORM
(PCD)
Pdevice
rocess
challenge
challenge
device
device
(PCD)
(PCD) (consisting of a plastic Helix-PCD to EN 867-5 and 200 indicator
1hallenge
3.1Process
Start-up
pack:
Order No:
213-260
C-F-PM-HPCD-KIT
strips)
Process
challenge
device
(PCD)
3.1UsedUsed
ininLTSF-sterilizers
totosufficient
test
formaldehyde
penetration.
The
strip
the
test
F-sterilizers
test
sufficient
formaldehyde
penetration.
The indicator
stripThe
is placed
in the
test
de-isisplaced
Used
intoLTSF-sterilizers
LTSF-sterilizers
to test
testsufficient
sufficient
formaldehyde
formaldehyde
penetration.
penetration.
indicator
Theindicator
indicator
strip
isstrip
placed
placed
in theinintest
thedetestdede-
FORM
Used in LTSF-sterilisers to test sufficient formaldehyde penetration. The indicator strip is placed in the test device. The test device is
Used
in LTSF-sterilizers
to testpackages
sufficient
formaldehyde
penetration.
The indicator strip is placed in the test deThe
test
device
isissterilized
together
with
other
packages
and
st device
sterilized
together
with
other
and
containers.
sterilised
together
with
other
packages
and with
containers.
vice.isvice.
vice.
The
test
The
device
test
device
is sterilized
sterilized
together
together
other
with
other
packages
packages
and containers.
andcontainers.
containers.
vice. The test device is sterilized together with other packages and containers.
Start-up
Start-up pack: Start-up
Start-up
pack:pack:
pack:
Start-up
pack:
Order
No:
C-F-PM-HPCD-KIT
Order No: 213-260
C-F-PM-HPCD-KIT
Order
Order
No: 213-260
No:213-260
213-260
C-F-PM-HPCD-KIT
C-F-PM-HPCD-KIT
Order
No: 213-260
C-F-PM-HPCD-KIT
(consisting
plastic
Helix-PCD
EN
(consisting of a plastic
Helix-PCD
867-5
and 200
(consisting
(consisting
of a of
plastic
oftoaaEN
plastic
Helix-PCD
Helix-PCD
to ENto
to867-5
EN867-5
867-5
and and
200
and200
200
(consisting
of
a
plastic
Helix-PCD
to
EN
867-5
and
200
indicator
strips)
indicator strips) indicator
indicator
strips)
strips)
indicator strips)
strips
for
sterilisation
processes
strips
forIndicator
formaldehyde
sterilisation
processes
2 3.2
3.2Indicator
Indicator
strips
strips
for formaldehyde
forformaldehyde
formaldehyde
sterilisation
sterilisation
processes
processes
3.2The
Indicator
for
formaldehyde
sterilisation
processes
indicator
strips
can
be
used
ininPCD
the
above.A
successful
isisindicated
r strips
canThe
be Indicator
used
in strips
the
PCD
above.A
successful
sterilization
process
is sterilization
indicated
byprocess
a colour
3.2
strips
for
sterilisation
processes
indicator
The
indicator
strips
strips
can
be
can
used
beformaldehyde
used
in the
thePCD
PCD
above.A
above.A
successful
successful
sterilization
sterilization
process
process
is indicated
indicated
by a by
colour
byaacolour
colour
Theindicator
indicator
strips
can
be in
used
in the
PCDA above.A
sterilization
process
is indicated
a yellow
colourto brown.
yellow
to
The
be
used
the PCD
above.
successful successful
sterilisation process
is indicated
by a colour
change by
from
yellow
to change
brown.
change
change
fromfrom
yellow
fromstrips
yellow
tocan
brown.
tobrown.
brown.
change from yellow to brown.
Before sterilisation
After successful sterilisation
Before
sterilisation
After
successful
sterilisation
Before sterilisation
After successful After
sterilisation
Before
Before
sterilisation
sterilisation
After
successful
successful
sterilisation
sterilisation
Before
sterilisation
After
successful
sterilisation
Order
No.:
213-203,
C-F-PM
(refill
pack
with
250
indicators)
Order No.: 213-203,
C-F-PM
(refill213-203,
pack
with
250
indicators)
Order
Order
No.: 213-203,
No.:
C-F-PM
C-F-PM
(refill
(refill
packpack
with 250
withindicators)
250 indicators)
Order No.: 213-203, C-F-PM (refill pack with 250 indicators)
3.3 Self-adhesive
package
monitoring
indicator
3.3 Self-adhesive
package
monitoring
indicator
monitoring
indicator
3sive
3.3package
Self-adhesive
Self-adhesive
package
package
monitoring
monitoring
indicator
indicator
No.:
213-206,
C-F-P-5-58x35-W-SV4
(Label
dimension:
58 x 35 mm, available as a pack with 200 labels zig-zag folded)
3.3 Order
Self-adhesive
package monitoring
indicator
Order
C-F-P-5-58x35-W-SV4
Order No.: 213-206,
C-F-P-5-58x35-W-SV4
Order
Order
No.: No.:
213-206,
No.:213-206,
213-206,
C-F-P-5-58x35-W-SV4
C-F-P-5-58x35-W-SV4
Order
213-206,
C-F-P-5-58x35-W-SV4
dimension:
Label dimension:
58 Label
xNo.:
35
mm
Label
Label
dimension:
dimension:
58 x 58
35
58xmm
x35
35mm
mm
Label dimension: 58 x 35 mm
Available
pack
200
(zig-zag
folded)
Available as a pack
with
200
folded)
Available
Available
aslabels
a as
pack
asaa(zig-zag
pack
withwith
200
with
labels
200labels
labels
(zig-zag
(zig-zag
folded)
folded)
Available as a pack with 200 labels (zig-zag folded)
Double-adhesive
endless
labels
indicator
on
3”
core
for
dhesive
endless
labelsendless
with
indicator
on with
roll
with
a on
3” core
forwith
printers
4 3.4
3.4Double-adhesive
Double-adhesive
endless
labels
labels
with
with
indicator
indicator
roll
on roll
with
roll
with
a 3”aacore
3”with
core
for aprinters
for printers
printers
withwith
with
a aa
3.4
Double-adhesive
endless
withindicator
indicator
3” for
core
for printers
with a
cutting
device
(7
70
m)
3.4
endless
labels with
onon
rollroll
withwith
a 3” acore
printers
with a cutting
7 cm
xdevice
70
m)Double-adhesive
utting
cutting
device
(7 cm
(7 cm
xcm
70xxm)
70
m) labels
cutting
device
(7
cm
x
70
m)
device
(7cm
x
70m)
Order
No:
213-390,
C-F-L-1-70-DA
After
the
information
is
printed
and
the
label
is
cut
to
the
required
length
by
the
printer
it
can
be
stuck
to
sterilisation
rmation
is printed
and
the label
isiscut
to the
required
length
bytorequired
the
it can
stuck
sterilisation
After
After
the information
the
information
is printed
printed
and
the
and
label
the label
is cut
istocut
the
theprinter
required
length
length
bybethe
byprinter
thetoprinter
it canitbe
can
stuck
be stuck
to sterilisation
to sterilisation
After
the
is is
printed
and
thehas
labellabel
is cutis
tocut
thetorequired
length length
by the printer
itprinter
can
be itcan
stuck
to
packs
orthe
pouches.
After
the
information
printed
and
the
the
required
by the
can
besterilisation
stuck to sterilisation
packs
ororinformation
pouches.
After
the
pack
opened
for
the
label
be
onto
uches.packs
After
thepouches.
pack
hasAfter
been
opened
for
medical
treatment,
the
label
cantreatment,
be transferred
onto
the
packs
or
pouches.
After
the
pack
thefor
pack
has
been
hasbeen
been
opened
opened
for
medical
formedical
medical
treatment,
treatment,
theonto
label
the
label
can
be
can
transferred
betransferred
transferred
onto
the
onto
the
After
theor
pack
has been
opened
medical
treatment,
the label
can
be
transferred
the
patient
documentation.
The
chemical
packs
pouches.
After
the
pack
has
been
opened
for
medical
treatment,
the
label
can
be
transferred
onto
the
patient
documentation.
The
chemical
indicator
provides
the
information
as
to
whether
the
pack
has
passed
the
mentation.
The
chemical
indicator
provides
the information
asthe
to whether
the as
pack
hastopassed
patient
patient
documentation.
documentation.
The chemical
The
chemical
indicator
indicator
provides
provides
information
the the
information
to as
whether
whether
the the
pack
the pack
has passed
has passed
the the
indicator
provides
the information
as to whether
the pack
has passed
sterilisationasprocess.
patient
documentation.
The
chemical
indicator
provides
the
information
to
whether
the pack has passed the
sterilisation
process.
process.
sterilisation
sterilisation
process.
process.
sterilisation process.
Order
C-F-L-1-70-DA
Order No.: 213-390,
C-F-L-1-70-DA
Order
Order
No.: No.:
213-390,
No.:213-390,
213-390,
C-F-L-1-70-DA
C-F-L-1-70-DA
Order No.: 213-390, C-F-L-1-70-DA
23
4.0
4.0
Chemical indicators to monitor hydrogen peroxide (H 2O2
plasma
processes (H O )/
4.0
Chemical
to monitor
hydrogen
peroxide
Chemical
indicatorsindicators
to monitor hydrogen
peroxide
(Hsterilisation
2O2)/
2 hydrogen
2
No cellulose carriers (paper) should beVH2O2
used for
peroxide ster
plasma
sterilisation
processes
plasma sterilisation processes decomposes H O into oxygen and water. Therefore aVH202
plastic carrier is
2 2
No cellulose carriers (paper) should be used for hydrogen peroxide sterilisation processes as cellulose
decomposes H2O2 into oxygen and water. Therefore
plastic
carrier
is used.
4.1 aperoxide
Testset
and
Process challenge devices (PCD)
4.0 Chemical indicators
to monitor hydrogen
(H
2O2)/
VH2O2
Used in hydrogen
sterilisation
processes.
The indicator strip is
No cellulose carriers (paper) should be used for hydrogen
peroxideperoxide
sterilisation
processes
as cellulose
4.1peroxide
Testset
and
Process
challenge
devices
(PCD)
plasma
sterilisation
processes
gen
(H
O
)/
2 2
device
is
sterilised
together
with
other
packages
and
containers.
VH2O2
into oxygen
water.
a plastic
carrier
used.
decomposes
H2Operoxide
2 (paper)
Used
in hydrogen
sterilisation
The indicator
stripsterilisation
is
placedisinprocesses
the test device.
The test
No cellulose
carriers
shouldand
beprocesses.
used
forTherefore
hydrogen
peroxide
as cellulose
is sterilisation
sterilised
with and
other
packages
and containers.
decomposes
H2O2together
into
oxygen
water.
Therefore
a plastic carrier is used.
hydrogen device
peroxide
processes
as
cellulose
4.1
Testset
and
Process challenge
(PCD)
efore
carrier
isindicators
used.
4.1a plastic
Testset
and
Process
devices
(PCD)
4.0
Chemical
tochallenge
monitordevices
hydrogen
peroxide (H O )/
Order No. Product code
Tube
2
214-015
C-V-HPCD-TS-6
Length
Order
No. Product
code 2in the
Quality
Diameter
Used in hydrogen peroxide sterilisation processes. The
indicator
strip is placed
test
device. The test
deviceVH2O2
is sterilised
together
Used
in
hydrogen
peroxide
sterilisation
processes.
The
indicator
strip
is placed
device. The214-225
test
C-V-HPCD-2-25
[mm]in the test[cm]
plasma
sterilisation
processes
s (PCD) with
other packages and containers.
214-015
C-V-HPCD-TS-6
Various
Various
6+50
214-325
device
is sterilised
with
other
and containers.
No
cellulose
(paper)
should
be packages
used
for
hydrogen
peroxide sterilisation2 processes as
cellulose214-350 C-V-HPCD-3-25
es. The indicator
strip
iscarriers
placedtogether
in the test
device.
The test
214-225
C-V-HPCD-2-25
25
C-V-HPCD-3-50
decomposes H2O2 into oxygen and water. Therefore
a plastic
carrier is used. 3 Tube 2 5
and containers.
214-325
C-V-HPCD-3-25
214-425
C-V-HPCD-4-25
Order
No.
code
(mm) Length
Tube Length
(cm) Quantity
Order
No. Product
Product
code Tube Diameter
Quality
Diameter
214-350
C-V-HPCD-3-50
3
5
0
214-475
C-V-HPCD-4-75
Tube
[cm]
4.1 Testset and Process
challenge
devices
(PCD)
214-425
C-V-HPCD-4-25 Various [mm]
4
2Various
5
214-5256+50C-V-HPCD-5-25
214-015
C-V-HPCD-TS-6
Length
er No. Product code
Quality
Diameter
214-015 C-V-HPCD-4-75
C-V-HPCD-TS-6
Various
214-475
4 in the test Various
75
1test
214-550
C-V-HPCD-5-50
Used in hydrogen [mm]
peroxide sterilisation
processes.
The
indicator
strip 2is placed
device.
The6+50
[cm]
214-225
C-V-HPCD-2-25
25
1
214-225
C-V-HPCD-2-25
2
25
214-525
C-V-HPCD-5-25
5
2
5
214-575
C-V-HPCD-5-75
4-015 C-V-HPCD-TS-6
6+50 214-325
device is sterilisedVarious
together withVarious
other packages
and containers.
C-V-HPCD-3-25 3
205
214-325
214-550 C-V-HPCD-3-25
C-V-HPCD-5-50
53
525
214-510 C-V-HPCD-5-100
4-225
C-V-HPCD-2-25
2
25
214-350 C-V-HPCD-5-75
C-V-HPCD-3-50
550
214-575
53 Tube
750
100
214-350
C-V-HPCD-3-50 3
4-325
C-V-HPCD-3-25
3
25
214-425
C-V-HPCD-4-25
4 hydrogen
2 peroxide
5
Length
Order
No. C-V-HPCD-5-100
Product
code stripsDiameter
Qualitysterilization proce
4.2
Indicator
for
214-510
5
4-350
C-V-HPCD-3-50
3
50
214-425
25
214-475 C-V-HPCD-4-25
C-V-HPCD-4-75 4
4
75
1
[cm]
[mm]
100
4-425
C-V-HPCD-4-25
4
25
The
indicator
strips
can
be
used
in
the
PCDs
above.
Please refer to the
214-525
C-V-HPCD-5-25
5
2
5
214-015
C-V-HPCD-TS-6
Various
Various
6+50
214-475
C-V-HPCD-4-75
4
75
4.2 C-V-HPCD-4-75
Indicator strips 4for hydrogen
sterilization
processes
4-475
7 5 peroxide
1 214-550
C-V-HPCD-5-50
50
interpretation.5
214-225 C-V-HPCD-5-25
C-V-HPCD-2-25
25
25
214-525
25 chart for
4-525
C-V-HPCD-5-25
The indicator strips 5can be used 2in5the PCDs
above.
refer to the gke35colour reference
214-575 Please
C-V-HPCD-5-75
214-325
C-V-HPCD-3-25
2755
4-550
C-V-HPCD-5-50
5
50
Order No.: 214-203,
C-V-PM
(Refill
214-550
5
50
214-510 C-V-HPCD-5-50
C-V-HPCD-5-100
interpretation.
214-350
C-V-HPCD-3-50
35
5 0pack with 250 indicators)
4-575
C-V-HPCD-5-75
5
75
100
214-425 C-V-HPCD-5-75
C-V-HPCD-4-25 5
4
25
214-575
75
4-510
air removal, insufficient
Order
No.: 214-203,
C-V-PM
(Refill pack
with
250
indicators)
4.2 C-V-HPCD-5-100
Indicator
strips5 for
hydrogen
peroxide
sterilization
processes4Insufficient
214-475
C-V-HPCD-4-75
75
1
O
penetration
H
214-510 C-V-HPCD-5-100 5
100
2 2
100
214-525
C-V-HPCD-5-25
5
2
5
The indicator
strips can
be used
in the PCDs
above. Please refer to the gke colour reference chart for
sterilization
processes
Insufficient
air removal,
insufficient
214-550
C-V-HPCD-5-50
5Insufficient temperature,
5 0 no air
O
penetration
H
2
2
ove. Pleaseinterpretation.
refer to the gke colour reference chart for214-575 C-V-HPCD-5-75
5removal, and no H72O52 penetration
Insufficient temperature, no air 214-510
C-V-HPCD-5-100
5Sufficient air removal and H2O2
Order
No.: 214-203,
C-V-PM
(Refill pack
with 250 indicators)
package monitoring indicator
4.2
Indicator
stripsremoval,
for hydrogen
penetration
and no H2O2peroxide
100 4.3 Self-adhesive
penetration
Examples
ofprocesses
HNo.:
O indicator
strips colour
change
sterilisation
processes
Order
214-206,
C-V-P-58x35-W
(Label dimension: 58 x 35 mm
Indicator strips
for
hydrogen
peroxide
sterilization
2504.2
indicators)
Insufficient
removal,
Sufficient
air air
removal
andinsufficient
H 2 O2
H2O
Available
as
package
with
200
labels
zig-zag
folded)
Order
No.:
214-203,
C-V-PM
(Refill
pack
with
250
indicators)
penetration
2 penetration
The
indicator strips can be used in the PCDs above. Please refer to the gke colour reference
chart
for
Examples of H O indicator strips colour change
The
indicator strips can beInsufficient
used in the
PCDs
above.
Please
refer
temperature,
no
air
4.3 Self-adhesive package monitoring indicator
interpretation.
2
2
4.3
to the
2
2
colour reference
chart for
removal,
and interpretation.
no H2O2 penetration
Order
No.: 214-203,
C-V-PM
(Refill
pack with
250 indicators)
Self-adhesive
package
Sufficient monitoring
air removal and H2Oindicator
2
Order No.: 21
Label dim
penetration
Insufficient
air removal, insufficient
Examples of H2O2 indicator strips colour
changeair removal,
Insufficient
insufficient H O penetration
H2O2 penetration
4.3
dicator
2
2
Order No.: 214-206, C-V-P-58x35-W
Self-adhesive package monitoring indicator Label dimension: 58 x 35 mm
Insufficient temperature,
no air removal,
Insufficient
temperature,
no air and no
H2O2 penetration
removal,
and no H2O2 penetration
Sufficient
removal
H 2 O2
O2 penetration
Sufficient air air
removal
and H2and
penetration
Available as pa
(zig-
Available as package with 200 labels
Order No.:
214-206,
C-V-P-58x35-W
(zig-zag
folded)
Label dimension: 58 x 35 mm
Examples of H2O2 indicator strips colour change
Order No.: 214-206, C-V-P-58x35-W
4.4 Self-adhesive package monitoring indicator, without mar
Self-adhesive
package
monitoring
indicator
Label dimension: 58 x 35 mm
4.4 Self-adhesive
packagemonitoring
monitoring indicator,
indicator, without
printing
option
Available
as package
with 200
labels
Self-adhesive
package
withoutmarking
marking
printing
option
gke Steri-Record C-V-P
(zig-zag
folded)
Hydrogenperoxide/Plasma
Available as package with 200 labels
Packing Indicator
VH2O2
gke Steri-Record
C-V-P
gke Steri-Record C-V-P
VH2O2 No.: 214-206,
Order
C-V-P-58x35-W
(zig-zag folded)
Hydrogenperoxide/Plasma
Hydrogenperoxide/Plasma
Label dimension:
58 x 35 mm
Packing Indicator
Packing Indicator
Order No.VH2O2
Product Code
Quantity
VH2O2
4.4 Self-adhesive
package
monitoring indicator,
without marking
printing
Before sterilisation option
After
214-221
C-V-P
400
Before
sterilisation
Available
as
package
with
200
labels
cator, without marking
printing
option
Beforegke
sterilisation
After
successful
gke Steri-Record
C-V-P
Steri-Record C-V-P
Ordersterilisation
No.800
Product Code
214-222
(zig-zag
folded)
4.3
4.4
®
®
®
®
®
VH2O2
4.4
Order No.
Hydrogenperoxide/Plasma
214-221
Packing
Indicator
214-223 VH2O2
Product Code
214-221
Quantity
214-222
400
214-223 option
Self-adhesive package monitoring indicator,
without marking
printing
C-V-P
214-222
Before sterilisation
After800
successful sterilisation
After successful sterilisation
3,200
214-223
gke Steri-Record C-V-P
gke Steri-Record
C-V-P
After successful
sterilisation
VH2O2
duct Code 24VH2O2
C-V-P
Hydrogenperoxide/Plasma
®
gke Steri-Record
C-V-P
Packing Indicator
Hydrogenperoxide/Plasma
3200
Packing Indicator
®
Order No.
Hydrogenperoxide/Plasma
Indicator
214-221
QuantityPacking
214-222
400
214-223
Before
800 sterilisation
Product Code
C-V-P
®
Quantity
Hydrogenperoxide/Plasma
400 Packing Indicator
800
3,200
After successful
sterilisation
VH2O2
C-V-P
8
3
h hydrogen peroxide process indicator for printers
5 Labels
withwith
hydrogen
peroxide
process
for
printers
4.5labels
Labels
with
hydrogen
peroxide
process
indicator
for
printers
elf-adhesive
a class
1 process
indicator
to ENindicator
ISO
11140-1
are
available on a roll with
double
self-adhesive
labels
with
1 process
indicator
to EN ISO
11140-1
available
a roll with on
a 3“acore
be used in
The
double
self-adhesive
labels
witha aclass
class
1After
process
to EN
ISO are
11140-1
areoncan
available
roll to
with
be used
inThe
printers
with
or without
a cutting
device.
the indicator
information
is printed
the
label
printers
with
or
without
a
cutting
device.
After
the
information
is
printed
the
label
can
be
adhered
to
sterilisation
packs
or
pouches.
a 3“ corepacks
to beorused
in printers
or without
a cutting
device. treatment
After the information
is be
printed the label can
o sterilisation
pouches.
After with
the pack
is opened
for medical
the label can
After
the
pack
is
opened
for
medical
treatment
the
label
can
be
transferred
to
the
patient
documentation.
The
chemical
indicator
be adhered
to sterilisation
or pouches.
the pack
is opened for
treatment
o the patient
documentation.
Thepacks
chemical
indicatorAfter
provides
the information
asmedical
to whether
the the label can be
provides the information as to whether the pack passed the hydrogen peroxide sterilisation process.
transferred
to the sterilisation
patient documentation.
the hydrogen
peroxide
process. The chemical indicator provides the information as to whether the
pack passed the hydrogen peroxide sterilisation process.
bels to be used in printers with a cutting device (7 cm x 60 m)
5.1.
Endless
labels
be used
in and
printers
with
a cuttingpacks
device
(7 cm x 60 m)
be printed
and cut
to theto
required
length
be stuck
to sterilisation
or pouches.
The label can be printed and cut to the required length and be stuck to sterilisation packs or pouches.
4.5.1 Endless labels to be used in printers with a cutting device (7cm x 60m) Order No: 214-390, C-V-L-1-70-DA
The label can be printed and cut to the required length and be stuck to sterilisation packs or pouches.
Order No.: 214-390, C-V-L-1-70-DA
Order No.: 214-390, C-V-L-1-70-DA
els to be used in printers without a cutting device
5.2labels
Single
labels
to be
used
in(16
printers
a cutting
device
ed
(48 x 78
mm) with
centre
Split
mm fromwithout
the bottom
of the label)
can be printed with all
4.5.2
Single
labels
to
bemm)
usedwith
in printers
without
afrom
cutting
deviceofOrder
No: 214-373, C-V-L-1-80x50-SU-DA
The
perforated
labels
(48
x
78
centre
Split
(16
mm
the
bottom
can be printed with all
mation andThe
adhered
to sterilisation packs or pouches. After the pack has been openedthe
forlabel)
medical
perforated labels (48 x 78 mm) with centre Split (16 mm from the bottom of the label) can be printed with all relevant information
to sterilisation
packs The
or pouches.
the pack
has been
e labelrelevant
can
beinformation
transferredand
to adhered
the patient
documentation.
chemicalAfter
indicator
provides
theopened for medical
and adhered to sterilisation packs or pouches. After the pack has been opened for medical treatment, the label can be transferred to the
treatment,
the
label
can
be
transferred
to
the
patient
documentation.
The
chemical
indicator
provides the
s to whether
the package
passed
sterilisation
process.
patient
documentation.
Thethe
chemical
indicator
provides the information as to whether the package passed the sterilisation process.
information as to whether the package passed the sterilisation process.
Order No.: 214-373, C-V-L-1-80x50-SU-DA
Order No.: 214-373, C-V-L-1-80x50-SU-DA
Split 16 mm from button
Split 16mm
Split 16 mm from button
from bottom
25
5.0 GKE Steri-Record® Documentation System
For steam, ethylene oxide, formaldehyde and hydrogen peroxide/plasma sterilisation processes
Application
The
Steri-Record® Documentation system is used for patientrelated traceability of all medical sterilisation processes. The
documentation sheet contains all the necessary information to
release a sterilisation batch. For any one steriliser and any one
day, one documentation sheet is used. Using a
labelling
device the documentation sheet and each sterile packing can
be labelled with a self-adhesive label that contains the following
information: production and expiry date, responsible person,
content of the pack, steriliser, and batch number (see figure
“recommended label content” next page). All packs in the batch
and the documentation sheets have the same label content and
batch number.
After opening the sterile pack in the operating room the label
can be peeled off and stuck to the patient and/or operationrelated documentation. The content of the label allows patient
related tracing back to the batch-related documentation in the
sterilisation department. In the case of a nosocomial infection the
sterilisation data is available to exclude the infection being caused
by non-sterile instruments.
Labels without or with an indicator for steam sterilisation
processes are available in four colours: red, green, blue, or yellow.
Different colours allow staff to differentiate sterile goods from
different production periods, enabling a correct First In/First Out
(FIFO) storage handling system.
26
Product description
The
documentation system consists of the following
components:
• Hand-labeler containing three printing lines with 12 digits each,
available in the following two versions:
• The whole first line can print alphanumeric digits (Doku Labeler-A).
• The first three digits of the first line can print alphanumeric
digits, the remaining ones print numbers (Doku-Labeler-N).
The remaining two printing lines allow production and expiry
date documentation.
• Selection of self-adhesive and double self adhesive labels with
or without class 1 process indicators to EN ISO 11140-1 for
steam, ethylene oxide, formaldehyde,or hydrogen peroxide/
plasma sterilisation processes. Some versions are available in
four different background colours.
• Documentation sheet to stick indicator strips from PCDs and
the labels (see documentation sheet above).
Labels for the following sterilisation processes:
Sterilisation
process
Indicator colour
(without penetration)
Indicator colour
(after penetration)
Steam
Labels
forfor
thethe
following
sterilisation
processes:
Labels
following
sterilisation
processes:
Ethylene
Sterilisation
oxide Indicator colour
process
(without penetration)
FormaldeSteamhyde
Hydrogen
Ethylene
peroxide
oxide
Indicator colour
(after penetration)
blau
FormaldeBackground information
hyde
The European Medical Device Directive (MDD)
Hydrogen
blau
requires that reprocessing
of medical devices uses
peroxide
appropriate
validated
procedures
and
documentation of the results of the validation
Background
information
processinformation
and routine monitoring. The quality
Background
management
standard
for medical
devices
(EN
The
European
Medical
DeviceDevice
Directive
(MDD)
requires
thatISO
The European Medical
Directive
(MDD)
13485)
and
the
validation
standards
of all
reprocessing
of reprocessing
medical devicesofuses
appropriate
validated
requires that
medical
devices
uses
sterilization
processes
(e.g.
EN
ISO
14937,
EN
procedures
and documentation
results of the validation
appropriate
validated of the
procedures
and ISO
17665-1
etc.)
require
monitoring
and
documentation
documentation
the results
of themanagement
validation
process
and routineofmonitoring.
The quality
of all
relevant
sterilisation
processThe
parameters.
This
process
routine
quality
standard
forand
medical
devicesmonitoring.
(EN ISO 13485)
and the
validation
documentation
is
required
for
the
production
management
forprocesses
medical(e.g.
devices
(EN
ISO ENorISO
standards
of allstandard
sterilisation
EN ISO
14937,
reprocessing
of
all
medical
devices
independent
of
13485) etc.)
andrequire
the monitoring
validation
of ofall
17665-1
and standards
documentation
all
where
they
are
sterilised.
For
each
individual
load
sterilization
processes
(e.g.
EN ISO 14937,
EN ISO ais
relevant
sterilisation
process
parameters.
This documentation
batch
number
is
required
associated
with
all relevant
17665-1 etc.) require monitoring and documentation
required
for the production
or reprocessing
ofprocess.
all medical devices
parameters
used
in
the
sterilisation
of all relevant sterilisation process parameters. This
If a steriliser with two doors is used and one door
opens in the storage room, labels without process
indicators can be used under the condition that the
door opens only after the steriliser program has
checked the correct
process conditions.
Steri-Record® documentation labels with process indicators
If aaresteriliser
with two doors is used and one door
available for different sterilisation processes (see above colour
opens in the storage room, labels without process
chart) and make the use of an additional process indicator
indicators
can be used under the condition that the
Benefits
(e.g.
an autoclave tape) redundant.
door
opens
only after the steriliser program has
� Easy
print ofprocess
identical
labels with minimum time
checked
the correct
conditions.
and effort.
If a steriliser
with two doors is used and one door opens in the
storage
room, labels
without process
can be used under
� Eliminates
mistakes
in batchindicators
numbers.
the condition that the door opens only after the steriliser program
Benefits
� checked
Easy trace
back system
without additional effort.
has
the correct
process conditions.
� Easy
printself-adhesive
of identical labels
minimum
time
� The
labelwith
offers
patient-related
and effort.
documentation without additional paperwork.
Benefits
Easy print of
identicalin
labels
with
minimum time and effort.
� •Eliminates
mistakes
batch
numbers.
� Innovative
product
design
and manufacturing
• Eliminates
mistakes
in batch
numbers. indicator.
process
provides
a
cost-effective
� Easy trace back system without additional effort.
• Easy trace back system without additional effort.
� Easy
interpretation
ofoffers
the
results
duedocumentation
to precise
� •The
self-adhesive
label
patient-related
The
self-adhesive
label
offers
patient-related
colour
change.
documentation
without
additional paperwork.
without additional
paperwork.
� No need
for additional
indicators
using
Innovative
product
design
andprocess
manufacturing
process
provides
� •Innovative
product
design
and
manufacturing
labels
withindicator.
an
indicator.
a cost-effective
process
provides
a cost-effective
indicator.
• Easy
interpretation
of the
results
due to precise
colour change.
� The
expiry date
marked
different
� Easy
interpretation
ofcan
the be
results
due using
to precise
• No need
for
additional
process
indicators
using
labels
with an
background
colour
change. label colours.
indicator.
� need
Lessfor
time
wasted inprocess
the CSSDand/orusing
theatres.
� No
additional
indicators
�
independent of where they are sterilised. For each individual
documentation is required for the production or
load aItbatch
numberthat
required
associated
with to
all be
relevant
is required
all sterile
packsindependent
have
labelled
reprocessing
of allismedical
devices
of
�
parameters
used
in
the
sterilisation
process.
It
is
required
with
a
class
1
process
indicator
according
to
EN
ISOall
where they are sterilised. For each individual load
athat
toto
ensure
that
the apacks
passed
the �
sterile
packs
have
be labelled
with
class
process
indicator
batch11140-1
number
is
required
associated
with1have
all
relevant
sterilisation
process
and
can
be
differentiated
from
according
to EN
ISOin11140-1
to ensure that
the packs have
parameters
used
the sterilisation
process.
packs.
passednon-sterilised
the sterilisation
process and can be differentiated from
�
® packs have to be labelled
non-sterilised
packs.
It is required
that all sterile
Steri-Record
documentation labels with
with process
a class 1 process
indicator
EN ISO
indicators
are according
available tofor
different
11140-1
to
ensure
that
the
packs
have
passed
the and
sterilisation processes (see above colour chart)
sterilisation
process
and
can
be
differentiated
from
make the use of an additional process indicator (e.g.
non-sterilised
packs.
an autoclave
tape) redundant.
• The expiry date can be marked using different background label
labels
with
an indicator.
� The
label
contains a specified class 1 chemical
colours.
to
ISO
11140-1.
•The
Lessindicator
time
wasted
in
the
and/or
theatres.
expiry date EN
can
beCSSDmarked
using
different
•background
The
label
contains
a
specified
class
1
chemical
indicator to
label
colours.
� Environmentally friendly, all
chemical
EN ISO
11140-1.
protected
Less indicators
time wastedarein the
CSSD-from
and/orbleeding
theatres. by a
• Environmentally
friendly,
chemical
polymer binder
andallsurface
coatingindicators
and canare
be
The
label
contains
a
specified
class
1
chemical
protected
from
bleeding
by
a
polymer
binder
and surface
disposed with normal waste.
indicator
to EN
11140-1.
coating and
can ISO
be disposed
with household waste.
� The indicator colour chemistry is a non•Environmentally
The indicator colourfriendly,
chemistryall
is a nonreversible chemical
reversible chemical reaction. Thechemical
indicator strip
reaction.
The
indicator
strip
can
be a documented
indicators
protected from
by proof
ayearsfor
can beare
a documented
proofbleeding
for several
several
years
without
changing
back
to
its
original
colour.
polymer binder and surface coating and can be
without changing back to its original colour.
disposed with normal waste.
� The indicator colour chemistry is a nonreversible chemical reaction. The indicator strip
can be a documented proof for several years
without changing back to its original colour.
Steri-Record® documentation labels with
process indicators are available for different
sterilisation processes (see above colour chart) and
make the use of an additional process indicator (e.g.
Initials of responsible person
an autoclave tape) redundant.
Steriliser no.
Batch no.
Package content
EM 01 02 11
Steri-Record®
2011-03-19


2011-06-19
Initials of responsible
person
Process indicator
Steriliser no.
Production date
Batch no.
Package content
Expiry date
EM Label
01 without
02 11indicators
Steri-Record
®
2011-03-19


2011-06-19
Sterilisation process
Indicator colour change


Steri-Record®
Label with
indicators
Sterilisation
process
Process indicator
Recommended
label documentation
Indicator colour change
Production date
Expiry date
Label without indicators


Steri-Record®
Label with indicators
Recommended label documentation
27
5.1
gke offers two different versions:
Hand labelling device
N=
numeric version: The first line contains three al
characters to print the responsible person’s init
as nine numeric characters to print the steriliser
number.
5.1 Hand labelling device
A=
alphanumeric version: The first line contains 12
gke
offers two different versions:
5.1
5.1 Hand
Hand labelling
labelling device
device
offers two different versions:
characters
print words
and/or
N==numeric
numeric
first linethree
contains
threetoalphanumeric
N
version:version:
The first The
line contains
alphanumeric
characters
to print
the numbers.
characters
to
print
the
responsible
person’s
initials
as
well
responsible person’s initials as well as nine numeric characters to print the steriliser
and batch
number.
as nine
numeric characters to print the steriliser and batch
A = alphanumeric
version: The first line contains 12 alphanumeric characters to print number.
gke
offers
two
versions:
gke
offers
two different
differentversion:
versions:
and/or
numbers.
A =words
alphanumeric
The first line contains 12 alphanumeric
N
=
numeric
version:
The
first
line
contains
three
The Nlines
contain
the
following
information:
= should
numeric
version:
The
first
contains
three alphanumeric
alphanumeric
characters to print wordsline
and/or
numbers.
characters
to
print
the
responsible
person’s
initials
characters to print the responsible
person’s initials as
as well
well
Person responsible
as
nine
numeric
characters
to
print
the
steriliser
and
batch
Steriliser
no.
as nine numeric characters to print the steriliser and batch
Batch no.
number.
number.
Package content
AA ==
alphanumeric
alphanumeric version:
version: The
The first
first line
line contains
contains 12
12 alphanumeric
alphanumeric
characters
to
print
words
and/or
numbers.
Sterilisation process
EM characters
01 02 11to print words and/or numbers.
The lines should contain the following information:
gke-Steri-Record®
Person responsible
2Steriliser
010-1
no.0 - 2 5
 Batch
 no.  
2 0 1 1content
-01-25
Package
Process indicator
Indicator colour change
Production date


gke-Steri-Record®
Expiry date
The
contain the
following information:
The lines
lines should
should
Sterilisation process
EM
01contain
02 11the following information:
®
Labeler with
three printing
lines
and
12
digits
each
Person
responsible
Process
indicator
gke-Steri-Record
Person
responsible
5.2 3-line single self-adhesive documentation labels
5.2
Steriliser no.
2010-10-25
Steriliser no.
colour change
Production
date
Available
with or
without steamIndicator
process
indicators. Each roll contains 1,000 labels (no ink roll
Batch
Batch no.
no.
2011-01-25
Without indicator
Order No.  
Product
 Code

240-850
5.2.1
Doku-Labeler-N
EM
02
EM 01
01 Doku-Labeler-A
02 11
11
240-840
®
gke
gke-Steri-Record
-Steri-Record®
Quantity
Package
content
Package
content
Expiry
date
Description1st

 line layout
gke-Steri-Record®
Three alphanumeric digits and nine numeric digits
Sterilisation
Sterilisation process
process
1
12 alphanumeric digits
Process
Process indicator
indicator
Production
Production date
date
3-line22single
documentation labels Indicator
00 11 00 -- 11self-adhesive
00 -- 22 55
Indicator colour
colour change
change
 
  steam process indicators. Each roll contains
 
 (no ink roll included).
Available
with or without
labels

 1,000 
®
22 00 11 11 -- 00 11 -- 22 55
Expiry
Expiry date
date
5.2 3-line single self-adhesive documentation labels
gke
gke-Steri-Record
-Steri-Record®
5.2.1 Available
Without
indicator
with or without steam process indicators. Each roll contains 1,000 labels (no ink roll included).
5.2
5.2
3-line
labels
3-line single
single self-adhesive
self-adhesive documentation
documentation
Order No.: 230-864labels
Available
Available with
with or
or without
without steam
steam process
process indicators.
indicators. Each
Each roll
roll contains
contains 1,000
1,000 labels
labels (no
(no ink
ink roll
roll included).
included).
5.2.1 Without indicator
5.2.1
Without
indicator
No.: 230-864
5.2.1 Order
Without
indicator
5.2.2 With indicator for steam sterilisation processes
Order No.: 230-864
5.2.2 With indicator for steam sterilisation processes
Order
Order No.:
No.: 230-864
230-864
Order No.: 230-871
-872
-873
5.2.2
With
indicator
for
sterilisation
processes
indicator
for steam
sterilisation
processes
5.2.2 5.2.2
With With
indicator
for steam
steam
sterilisation
processes
Order No.: 230-871
Order No: 230-871
Order
Order No.:
No.: 230-871
230-871
28
-872
-872
-872
-872
-873
-873
-873
-873
-874
-874
-874
-874
formaldehy
de sterilisation
processes
sterilisation
(colour:
(plasma) properties
red) and
peroxide
sterilisation
hydrogen
(plasma)
hydrogen
andwith
red) peroxide
peroxide
(colour:
andn hydrogen
processes
red)
(plasma)
(colour:
sterilisation
sterilisation
processes
formaldehyde
sterilisation
purple),
ple),
adhesion
advanced
labels
documentatio
self-adhesive
double
3-lineEach
5.3 formaldehyde
(colour:
green).
pack
contains
4 pack
or 124 contains
rolls
an ink roll.
with
each
750
roll. Before
labels
ink and
labels
an
with
each
rolls
each
oron12
and
750
anand
with
inkindicators.
rolls4or
roll.
12pack
or
green).
contains
pack
(colour:
Each
process
cess (colour:
the pack is opened
process
other750
oflabels
top
to the
directly
stuckEach
be
may
label
The green).
in the operation room the label is taken off and stuck to the patient documentation. It is available in 4 colours
ithout
indicator
5.3.1
indicator
Without
(colour:
3.15.3
indicator
processes
Without
oxide sterilisation
for ethylene
with a process indicator
indicators anddocumentation
process
steam
the
for
3-line
double
self-adhesive
labels
with advanced
adhesion
properties
sterilisation
(plasma)
peroxide
hydrogen
(colour:
processes
formaldehyde
purple),
The label
may be stucksterilisation
directly to the
pack or on
top ofred)
otherand
process
indicators.
Before
the pack is opened
roll.
ink
an
and
each
labels
750
with
rolls
12
4 orstuck to the patient documentation. It is available in 4 colours
contains
Each
(colour: green).
process
in the operation
room the
labelpack
is taken
off and
for the steam process indicators and with a process indicator for ethylene oxide sterilisation processes (colour:
5.3 3-line double
self-adhesive documentation labels with advanced adhesion properties
5.3.1
indicator
Without
purple),
formaldehyde
sterilisation processes (colour: red) and hydrogen peroxide (plasma) sterilisation
The label may be stuck directly to the pack or on top of other process indicators. Before the pack is opened in the operation room the
process
(colour:
green).
pack contains
4 or 12
rolls
with 750
labels for
each
anprocess
ink roll.
label is taken
off and
stuck toEach
the patient
documentation.
It is
available
in 4 colours
the and
steam
indicators and with a process
indicator for ethylene oxide sterilisation processes (colour: purple), formaldehyde sterilisation processes (colour: red) and hydrogen
5.3.1
peroxide
(plasma) sterilisation
Without
indicatorprocess (colour: green). Each pack contains 4 or 12 rolls with 750 labels each and an ink roll.
o.: 240-861
-862 -862
5.3.1No.:
Without
indicator
240-861
240-861
No.:Order
rder
-864
-863 (12
-863 (12 rolls) -864 -864
rolls)
(12 rolls)
-863
-853 (4-853
-853 (4 rolls)
rolls)
(4 rolls)
-862
-864
(12 rolls)
-863
-862
Order No.: 240-861
With
indicator
sterilisati
on processe
s processes
sterilisation
processes
steam
for
sterilisation
indicator
ansteam
for steam
Withfor
5.3.2
an indicator
With
3.2 an
-853 (4 rolls)
Order No.: 240-861
Order No: 240-861
-862
-862
-863 (12 rolls)
-863 (12 rolls)
-853 (4 rolls)
-864
-853 (4 rolls)
processes
sterilisation
steam
for
indicator
an
With
5.3.2
5.3.2 With an indicator for steam sterilisation processes
5.3.2
With
an-872
indicator
steam sterilisation
No.:
240-871
-873 (12-873
-873 (12 rolls) -874 -874
rolls)
rolls)
(12processes
-872 for -872
240-871
No.:
240-871
No.:Order
Order
-883 (4-883
-883 (4 rolls)
rolls)(4 rolls)
Order
No:No.:
240-871
240-871
Order
-872
-872
-873-873
(12 rolls)
(12 rolls)
-883-883
(4 rolls)
(4 rolls)
-874
-874
With
indicator
foranother
on processe
s
processes
sterilisation
processes
other
for
sterilisation
indicator
otherfor
for sterilisati
With
5.3.3
an indicator
With
3.3 an
5.3.3
With an indicator
other sterilisation processes
Order No.: 240-871
-872
-864
-873 (12 rolls)
-883 (4 rolls)
-874
-874
5.3.3 With an indicator for other sterilisation processes
5.3.3
With
an indicator
for
other
sterilisation
processes
:der
242-875
(12 rolls)
Order
No.:
244-871
No.:
243-873
rolls) (12 rolls)
(12
244-871
rolls)
No.:Order
rolls)
Order
243-873
No.:(12
rolls)
Order
Order
No.:
243-873
No.:
rolls)
244-871
Order
242-875
(12
rolls)
242-875
No.:Order
Order
No:
244-871
(12rolls)
rolls)(12
Order
No:
243-873
(12
rolls) (12
OrderNo.:
No:(12
242-875
(12(12
rolls)
42-885242-885
(2 rolls)(2242-885
rolls) (2 rolls)
(2244-881
(2 rolls)
244-881
(2 rolls)
rolls)
(2243-883
244-881
rolls) 243-883243-883
(2 rolls)
rolls) (2(2rolls)
244-881
(2 rolls)
243-883
(2 rolls)
242-885
thyleneethylene
oxide oxide
peroxide
hydrogen
formaldehy
peroxide
de
hydrogen
formaldehyde
hydrogen
formaldehyde
hydrogen
peroxide
formaldehyde
ethylene oxide
oxide
peroxide
ethylene
Double self-adhesive 3-line eco-labels
with standard adhesive quality, with or without an indicator, no conformity declaration, and no test reports
Order No.: 244-871 (12 rolls)
5.4
self-adhesive
eco-labels
Order
rolls) 3-line
(12 labels,
242-875
No.:
available.Order
EachDouble
roll contains
750
without
ink
roll. No.: 243-873 (12 rolls)
With standard
adhesive
no conformity
available.
(2 rolls)
244-881
(2 rolls)declaration, and no test reports
243-883
rolls) with or without an indicator,
(2 quality,
242-885
Each roll contains
750
labels,
without
ink
roll.
hydrogen peroxide
formaldehyde
ethylene oxide
Order No.: 242-875 (12 rolls)
242-885 (2 rolls)
ethylene oxide
Order No: 000-863
Order No.: 000-863
without indicator
without indicator
Order No.: 243-873 (12 rolls)
243-883 (2 rolls)
formaldehyde
Order No: 000-873
Order No.: 000-873
Steam
steam
Order No.: 244-871 (12 rolls)
244-881 (2 rolls)
hydrogen peroxide
Order No: 000-875
Order No.: 000-875
ethylene oxide
ethylene oxide
29
Combination of different labels together with 3-line labels
Self-adhesive 3-line labels without or with process indicator
Each package contains 12 rolls of 1000 self-adhesive labels.
Order No.
Product Code
Colour
Sterilisation process
230-864
Doku-1-L-12-Y
Yellow
Without indicator for all processes
230-871
Doku-1-L-D-12-G
Green
230-872
Doku-1-L-D-12-B
Blue
230-873
Doku-1-L-D-12-R
Red
230-874
Doku-1-L-D-12-Y
Yellow
232-875
Doku-1-L-E-12-P
Purple
Steam
Ethylene oxide
Double self-adhesive 3-line labels without or with process indicator
Each package contains rolls of 750 double self adhesive labels with one ink roll.
Order No.
Product Code
No. of rolls/pack Colour
4
Red
240-853
Doku-L-4-R
240-861
Doku-L-12-G
Green
240-862
Doku-L-12-B
Blue
240-863
Doku-L-12-R
Red
240-864
Doku-L-12-Y
240-871
Doku-L-D-12-G
240-872
Doku-L-D-12-B
Blue
240-873
Doku-L-D-12-R
Red
240-874
Doku-L-D-12-Y
240-883
Doku-L-D-4-R
4
242-875
Doku-L-E-12-P
12
242-885
Doku-L-E-2-P
2
243-873
Doku-L-F-12-R
12
243-883
Doku-L-F-2-R
2
244-871
Doku-L-W-12-G
12
244-881
Doku-L-W-2-G
2
30
12
Sterilisation process
Without indicator for all processes
Yellow
Green
Steam
Yellow
Red
Purple
Ethylene oxide
Red
Formaldehyde
Green
Hydrogen peroxide
Cleaning Indicators and Process Challenge Devices (PCDs)
6.0 Cleaning
Cleaning Indicators
and Process
ChallengeChallenge
Devices (PCDs)
6.0
Indicators
and Process
Devices (PCDs)
Cleaning
indicators
for Washer/Disinfectors
6.1 Cleaning
indicators
for Washer/Disinfectors(Wds)
(Wds)
Refill6.1
packs
withpacks
self-adhesive
cleaning
indicators
for
andmonitoring
monitoring
of cleaning
processes,
Cleaning
indicators
for Washer/Disinfectors
(WDS)
Refill
with self-adhesive
cleaning
indicators
for validation
validation and
of cleaning
processes,
on
Refill packs with self-adhesive cleaning indicators for validation and monitoring of cleaning processes, on cards with 16 double-sided
cards
with 16 double-sided
indicators
each.
indicators can
be
as double-sided
indicators
in the gke
cardsindicators
with 16
double-sided
indicators
each.
TheTheindicators
can
beused
used
as double-sided
indicators
in the g
each. The indicators can be used as double-sided indicators in the
holder or in the Hollow Flow-PCD. They can be stuck
or in theFlow-PCD.
Hollow
stuck
documentation.
holder
or inholder
the Hollow
TheyThey
cancan
be be
stuck
totodocumentation.
6.0
Indicators
andFlow-PCD.
Process
Challenge
Devices
(PCDs)
to Cleaning
documentation.
6.1
Order No.
Cleaning indicators for Washer/Disinfectors (Wds)
Order No.
Colour
Quantity
Product code
Colour
Introduction
packQuantity
with
Order No. Product code Colour
Quantity
Refill packs with self-adhesive cleaning indicators for validation
on
800-004 and monitoring
W-WA-L1-4 of cleaning processes,
Level
1-4
Introduction
pack wi
cleaning
indicators
800-004
W-WA-L1-4
Introduction
pack
cards with 16 double-sided indicators each. The indicators
can be used as
double-sided indicators in the gkeLevel 1-4
800-004
W-WA-L1-4
with Level160
1-4
810-101
cleaning indicators
holder or in the Hollow Flow-PCD. They can be stuck to documentation.
810-102
480
W-WA-L1
yellow cleaning indicators
810-101
160
810-103
960
810-101
W-WA-L1
Yellow
160
Order810-102
No.
Product code
Colour
Quantity 160
810-201
480
W-WA-L1
yellow
810-102
480
Introduction
pack
with
810-202
W-WA-L2
green
480
810-103
960
810-103
960 1-4
800-004810-203
W-WA-L1-4
Level
960
810-201
160
810-201
W-WA-L2
Greencleaning
160indicators
810-301
160
810-202
W-WA-L2
green
480
810-101810-302
160 480
W-WA-L3
blue
810-202
480
810-102
480 960
W-WA-L1
yellow
810-203
960
810-303
810-203
960
810-103
960
810-401
160
810-301
160
810-301
W-WA-L3
Blue
160
810-201810-402
160 480
W-WA-L4
red
810-302
W-WA-L3
blue
480
810-302
480
810-202810-403
W-WA-L2
green
480 960
810-303
960
810-203
960 64
810-900
810-303
960
green/
810-301
160 160
810-401
160
810-901
810-401
W-WA-L4
160
W-WA-MLCblueRed
blue/
810-302
W-WA-L3
480
810-902
480
810-402
W-WA-L4 red
red
480
810-402
480
810-303810-903
960 960
810-403
960
960
810-401 810-403
160
810-900
64
810-402
W-WA-L4
810-900
W-WA-MLC red Green/ green/
64480
6.2 Process challenge devices (PCD) 810-403
6.2.2
Holder for cleaning indicators
960
810-901
160
blue/red 160
810-901
W-WA-MLC
blue/ 64
To be used with cleaning indicators for WDs. 810-900
810-902
480
green/
red480
810-901 810-902
160
810-903
960
W-WA-MLC
blue/
810-903
960
6.2.1 Hollow Flow PCD
Process
challenge
(PCD)
6.2 Process
challengedevices
devices (PCD)
6.2
Product code
devices
(PCD)
To Process
be used withchallenge
cleaning indicators
for WDs.
810-902
810-903
480
960
red
6.2.2 Holder for cleaning indicators
To be used with cleaning indicators for WDs. 6.2.2 Holder for cleaning indicators
To be used with cleaning indicators for WDs.
6.2.1
Hollow
Flow
PCD
1 6.2.1
Hollow
Flow
PCD
Hollow
Flow
PCD
6.2.2 Holder for cleaning indicators
Order No. Product code
800-100
800-111
W-HO
W-HF-PCD
Order No. Product code
Order No. Product Code
Description
800-100
W-HO
Description
Holder
for cleaning indicators
Hollow Flow-PCD with 3 different
adapters of 2, 3, and 4 mm split
width as well as 2 LL-adapters and
a 0.5 m silicone tube
Description
HolderNo. Product Code Description
Order
for cleaning indicators
800-100
Hollow Flow-PCD
with 3 different
W-HO
Order
No. Product
code
Description
adapters of 2, 3, and 4 mm split Hollow Flow-PCD with 3 different
4 mm split
width as well as 2W-HO
LL-adapters adapters of 2, 3, andHolder
800-111 W-HF-PCD
710-002 EN V15 01/2012800-100
and a 0.5 m silicone tube
width as well
2 LL-adapters
and
forascleaning
indicators
800-111
W-HF-PCD
a 0.5 m silicone tube
800-111
W-HF-PCD
Holder for cleaning indicators
Hollow Flow-PCD with 3 different
adapters of 2, 3, and 4 mm split
width as well as 2 LL-adapters and
a 0.5 m silicone tube
Seite 22 von 24
31
6.3 Cleaning Indicators for ultrasonic cleaning baths
Refill packs with self-adhesive cleaning indicators to test ultrasonic cleaning baths, on cards with 4 indicators each. The indicators are
6.3 Cleaning Indicators for ultrasonic cleaning baths
placed horizontally or vertically in the liquid volume to check the cleaning efficacy inside the bath.
Refill packs with self-adhesive cleaning indicators to test ultrasonic cleaning baths, on cards with 4 indicators
each. The indicators are placed horizontally or vertically in the liquid volume to check the cleaning efficacy
inside the bath.
Order No.
Product code
800-014
Order No.
W-WA-L1-4
Product code
800-014
810-111
810-111
810-112
810-112
810-113
810-113
W-U-L1-4
W-WA-L1
810-211
810-211
810-212
810-212
810-213
810-213
810-311
810-312
810-311
810-313
810-312
810-411
810-313
810-412
810-413
810-411
W-U-L1
W-WA-L2
W-U-L2
W-U-L3
W-WA-L3
W-U-L4
W-WA-L4
BES Decon - a division of BES Rehab Ltd
131 South Liberty Lane Ashton Vale, Bristol, BS3 2SZ. UK
T: 0845 1300 237 F: 0845 1300 238
info@besdecon.net www.besdecon.net
© 2012 BES Rehab Ltd
Quantity
Introduction pack
Quantity
with Level 1-4
Introduction pack with
cleaning indicators
Level 1-4
Yellow cleaning
40
indicators
40
120
yellow
120
240 240
40
Green
40
green
120
120
240
240
40
blue
120
Blue
40
240
120
40
240 120
red
240
Red
40
Colour
810-412
120
810-413
240
BES Decon Details logo etc
Supporting your needs
Colour