National Health Service
Model engineering specifications
STANDARD REFERENCES
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BRITISH, EUROPEAN AND INTERNATIONAL STANDARDS
OTHER REGULATIONS, GUIDANCE AND CODES OF PRACTICE
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3
GENERAL
1
02
1.0 SCOPE
2.0 CHANGES TO SPECIFICATION
3.0 WARRANTY PERIOD
4.0 MANUFACTURERS QUALITY SYSTEM
5.0 REGULATORY REQUIREMENTS
6.0 THE PROCESS
7.0 ACCEPTABLE PROCESSES
8.0 WASHER DISINFECTOR PERFORMANCE
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TECHNICAL
1
03
01 OPERATING ENVIRONMENT
02 CHAMBER OPERATIONAL LIFE
03 WASHER DISINFECTOR CONSTRUCTION
04 MATERIALS OF CONSTRUCTION
05 SAFETY DEVICES AND SAFETY FEATURES
06 FRAME AND PANELS/FASCIA
07 CHAMBERS/CABINETS (TYPE 1 AND TYPE 2)
08 MULTI/SEQUENTIAL CHAMBERS/CABINETS INCLUDING TUNNEL TYPE (TYPE 2)
09 DOOR(S)
10 CONTROL OF DOORS OF A DOUBLE-ENDED WASHER-DISINFECTOR
11 MANUALLY OPERATED DOORS
12 INTERNAL DOORS AND ACCESS PORTS
13 AIR COMPRESSORS
14 AIR QUALITY
15 INTEGRAL CALORIFIERS/HEAT EXCHANGERS
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16 PIPEWORK AND FITTINGS.
17 STEAM SUPPLY PIPEWORK
18 WATER TANKS
19 HEATING SOURCES
20 TEST TEES
21 INSTRUMENTATION – GENERAL
22 TEMPERATURE INDICATORS
23 MEASUREMENT SYSTEMS (INCLUDING CONTROL, MONITORING AND RECORDING)
24 INDEPENDENT MONITORING AND RECORDING SYSTEMS (PROCESS VERIFICATION)- GENERAL
25 INDEPENDENT MONITORING AND RECORDING SYSTEMS (PROCESS VERIFICATION)– HARD COPY PRINT
OUT
26 VERIFICATION OF CALIBRATION OF TEST INSTRUMENTS
27 CONTROL SYSTEMS - GENERAL
28 MICROPROCESSOR SYSTEMS
29 COMMUNICATION PORT AND INTERFACES
30 CYCLE COUNTER
31 DOSING SYSTEMS
32 LOAD CARRIERS
33 LOAD TRANSPORT SYSTEMS (CONVEYORS)
34 TABLING
35 TRANSFER TROLLEYS (CARRIAGES)
36 MAINTENANCE ACCESS
37 ELECTRICAL SUPPLY, WIRING AND SWITCHGEAR
38 VENTILATION SYSTEMS AND DUCTWORK
39 WATER SUPPLY
40 NOISE EMISSIONS & SOUND POWER
41 THERMAL EMISSION, SURFACE TEMPERATURES AND INSULATION
42 MANUFACTURERS INSTALLATION
43 OPERATING INSTRUCTIONS
45 TECHNICAL DOCUMENTS, MANUALS, AND OTHER DOCUMENTATION
46 TRAINING
47 WORKS TESTING, COMMISSIONING AND PERFORMANCE TESTING
48.0 SERVICING AND MAINTENANCE
49 THROUGHPUT PROFILE – OUTPUT PERFORMANCE SPECIFICATION (METHOD 1)
50 ADDITIONAL INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
TEST METHODS
04
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1
01 GENERAL
02 LOAD CLEANLINESS
03 CHAMBER AND CARRIER CLEANLINESS.
04 DISINFECTION
05 LOAD DRYNESS
06 MICROPROCESSOR CONTROLLER – ACCEPTANCE TEST PROCEDURE
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C30 ELEMENT 01 PAGE
STANDARD REFERENCES1
1
01
The materials, components and completed installations shall conform as applicable with the following
Standards, including all amendments, current at the time of tendering. Construction products should
comply with European Standards and Technical Specifications (ESTS).
Wherever reference is made to a British standard a corresponding ESTS (generally ISO series) shall be
equally acceptable.
Where available all materials, equipment etc forming part, or whole of the services specified in the
Contract should be obtained from BS EN ISO 9000 – “Quality Assurance” certified manufacturers and
preferably “kite marked” or EC equivalent
BRITISH, EUROPEAN AND INTERNATIONAL STANDARDS
For dated references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
BS EN ISO 15883 -1
Washer-disinfectors - Part 1: General requirements, terms
and definitions and tests
BS EN ISO 15883 -2
Washer-disinfectors - Part 2: Requirements and tests for Washerdisinfectors employing thermal disinfection for surgical instruments,
anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
BS EN ISO 15883 – 5
Test soils and methods for demonstrating cleaning efficiency [Technical
Specification]
ISO 228-1,
Pipe threads where pressure-tight joints are not made on the threads — Part
1: Dimensions, tolerances and designation
ISO 7000,
Graphical symbols for use on equipment — Index and synopsis
ISO 10012,
Measurement management systems — Requirements for measurement
processes and measuring equipment
ISO 14644-3:2005,
Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14971,
Medical devices — Application of risk management to medical devices
ISO/TS 15883-5:2005,
Washer-disinfectors — Part 5: Test soils and methods for demonstrating
cleaning efficacy
IEC 60417-DB,
Graphical symbols for use on equipment
IEC 60584-1:1995,
Thermocouples — Part 1: Reference tables
IEC 60751:1983,
Industrial platinum resistance thermometer sensors
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C30 ELEMENT 01 PAGE
2
IEC 61010-2-045,
Safety requirements for electrical equipment for measurement, control, and
laboratory use — Part 2-045: Particular requirements for washer disinfectors
used in medical, pharmaceutical, veterinary and laboratory fields
IEC 80416-1,
ISO 9000:2005,
Basic principles for graphical symbols for use on equipment — Part 1:
Creation of symbol originals
Quality management systems — Fundamentals and vocabulary
ISO 9001:2000,
Quality management systems — Requirements
ISO 10993 (all parts),
Biological evaluation of medical devices
ISO 11737-1,
Sterilization of medical devices — Microbiological methods — Part 1:
Determination of a population of micro-organisms on products
ISO 11737-2,
Sterilization of medical devices — Microbiological methods — Part 2:
Tests of sterility performed in the validation of a sterilization process
ISO 13485:2003,
Medical devices — Quality management systems — Requirements for
regulatory purposes
ISO 14698-1,
Cleanrooms and associated controlled environments — Bio contamination
control — Part 1: General principles and methods
ISO/TS 11139,
Sterilization of health care products — Vocabulary
IEC 60073,
Basic and safety principles for man-machine interface, marking and
identification — Coding principles for indicators and actuators
EN 285,
Sterilization — Steam sterilizers — Large sterilizers
EN 554:1994,
Sterilization of medical devices — Validation and routine control of
sterilization by moist heat
EN 866-1:1997,
Biological systems for testing sterilizers and sterilization processes — Part
1: General requirements
EN 1717,
Protection against pollution of potable water in water installations and
general requirements of devices to prevent pollution by backflow
EN 1822-1:1998,
High efficiency air filters (HEPA and ULPA) — Part 1: Classification,
performance testing, marking
BS 1710:1984
Specification for identification of pipelines and services
BS7671:2008
Requirement for Electrical Installations (IEE wiring Regulations 17th
Edition)
BS 4196
Sound power levels of noise sources
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C30 ELEMENT 01 PAGE
OTHER REGULATIONS, GUIDANCE AND CODES OF PRACTICE
Medical Device Regulations MDD93/42/EEC
Health & Safety at Work etc Act 1974
Health Act 2006
Pressure Systems Safety Regulations 2000
The Electricity at work regulations
Data Note 46 Department of Health and Social Security
Health Technical Memorandum 00 – Policies & Principles
CfPP 01.01 - Decontamination of reusable Medical Devices, part A
Management & Environment
*Health Technical Memorandum 2020 - Electrical Safety Code for Low Voltage Systems (EscodeLV),
Health Technical Memorandum 02 – Medical Gases
Health Technical Memorandum 03 – Ventilation
*Health Technical Memorandum 2027 – Hot & Cold Water Supply, Storage and Mains Services
* Health Technical Memorandum 2040 – Control of Legionellae in Healthcare Premises
* Health Technical Memorandum 2045 – Acoustics
Note * : OR EQUIVALENT HEALTH TECHNICAL MEMORANDUM 00 SERIES
REPALACEMENT
Health Building Note 13 – Sterile Services Departments
Health Building Note 26 – Operating Departments
Health and Safety Executive Data Sheet 24
COSHH Regulations
National Physics Laboratory Symposium No: 72 – “Control of Noise” HMSO
Water Supply Licence (Prescribed Water Fittings Requirements) Regulations 2005
WHO – Guidelines for drinking-water quality 1996
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C30 ELEMENT 01 PAGE
4
Guide to Automated Manufacturing Practice Version 4:2001
Programmable Electronic Systems in Safety Related Applications:Part 1 an Introductory Guide
Part 2 General Technical Guidelines
Health & safety Executive Publications
80/778/EEC, Council Directive of 15 July 1980 relating to the quality of water intended for human
consumption
97/23/EEC, Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the
approximation of the laws of the Member States concerning pressure equipment
93/42/EEC, Council Directive of 14 June 1993 concerning medical devices
British Pharmacopoeia
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide)
European Pharmacopoeia, European Directorate for the Quality of Medicines, Council of Europe,
Strasbourg, France
United States Pharmacopoeia, USP Pharmacopoeia, Rockville, USA
End of Element
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C30 ELEMENT 02 PAGE 1
GENERAL
02
1.0 Scope
This Specification covers the supply and/or installation and/or commissioning of Washer-disinfector
equipment as defined generally below and in the following element(s). Details specific to the
scheme or site are included in Section D which must be completed by the Tenderer and returned to
the Purchaser as part of the completed Form of Tender.
If the Contractor's tender does not strictly comply with any or all of the details of this specification then
the contractor shall declare in the tender any such deviations together with full details of the
alternative(s) offered.
2.0 Changes to Specification
The client shall be notified by the manufacturer in writing not less than 14 working days before
commencement of manufacture, of any intent to make changes from the offer on which the contract was
awarded in respect of the specification and design of specified components, including any alterations
resulting from changes in relevant standards. No such change shall be made without the written consent
of the client.
Pre-Tender visits
Tenderers are advised to visit site before submitting a tender, and this can be arranged by contacting the
officer detailed in section D.
3.0 Warranty Period
The Manufacturer shall accept liability for defects for the Washer-disinfector, which occur within a 12
calendar months or 5,000 operational hours (whichever is the greater) period after acceptance of the
Washer-disinfector. Satisfactory completion of the required/specified performance tests will be a
prerequisite of acceptance.
This warranty period shall also include such of the following items as have been supplied including, but
not limited to:
–
software provide as part of the Washer-disinfector control system
–
loading accessories (tabling, conveyors, load carriages, baskets, adapters etc)
–
external calorifiers/heat exchangers
–
any water treatment plant supplied by the manufacturer
–
all service connections supplied by the Manufacturer (including but not limited to pipework,
control equipment and ductwork).
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C30 ELEMENT 02 PAGE 2
The guarantee shall cover all parts and labour. This shall include those parts identified as replacement
items in the maintenance schedule.
The length of warranty period offered shall be specified in the return tender documentation.
The Washer-disinfector shall be designed to withstand use for not less than 12 months or 5,000
operational hours (whichever is the greater) without suffering failure other than those components
identified on the maintenance schedule as requiring periodic replacement.
The repair and/or replacement of components (other than those specified within the maintenance
schedule for periodic replacement) within the warranty period shall be at the manufacturers expense
(parts and labour). This includes for making good free of charge any part thereof found to be defective
or showing signs of any weakness or undue wear in consequence of faulty workmanship or materials.
Manufacturers shall state within the section D clause 35 the mean time between failures (MTBF) figure
and guaranteed uptime for the Washer-disinfector.
The manufacturer shall inform the client of any recommended or required updates or upgrades to the
software system with an option for purchase for a period of 5 years from acceptance of the Washerdisinfector. Distinction shall be made between those updates/upgrades that provide “bug fixes” or are
maintenance releases and those that are providing added or new features.
4.0 Manufacturers Quality System
If the manufacturer has both designed and manufactured the Washer-disinfector the quality system
shall conform to BS EN ISO 9001/BS EN 46001 (or BS EN ISO 13485). If the Washer-disinfector
has been manufactured to a design supplied by a third party the manufacturer’s quality system shall
conform to BS EN ISO 9002/BS EN 46002 (or BS EN ISO 13488).
In either case the manufacturer shall ensure that each supplier of accessories, fittings and other
materials also operates an appropriate quality system and where appropriate the supplier shall
comply with the relevant Essential Requirements of Medical Devices Regulations.
Manufacturing records and quality system documentation shall be available for audit/inspection if
requested by the client.
5.0 Regulatory Requirements
The Washer-disinfector shall comply with the relevant Essential Requirements of Medical Devices
Regulations and shall be CE marked.
The supplier shall provide information on any relevant Standards or guidance documents used to
demonstrate compliance with the Regulations.
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C30 ELEMENT 02 PAGE 3
6.0 The Process
Shall:
conform to the performance required in BS EN ISO 15883 Part 1 and BS EN ISO 15883 Part 2
remove soiling of the various types occurring through the normal use of medical, surgical and anaesthetic
instruments, utensils, and equipment to the extent necessary for their safe re-sterilization and subsequent
re-use.
remove any chemical additives employed during processing through the washer disinfector to the extent
that any residuals can be demonstrated to have no adverse toxic effect on patient and/or staff. Biocompatibility studies or equivalent method shall be sufficient to demonstrate the safety of chemical
additive concentration levels.
not distort, damage or otherwise impair the utility of items processed through the machine where the
manufacturer of the items to be processed has indicated that they are suitable for processing in an
automated Washer-disinfector.
disinfect the items processed so that they may subsequently be handled without risk of infection from
viruses, vegetative bacteria or fungi.
where required, dry the cleaned items so that they are free from visible water
achieve this performance specification by an automatic operating cycle which has a number of pre-set
variables and specified stages including those for:a) cleaning
b) disinfecting
c) rinsing
d) drying (where required)
7.0 Acceptable Processes
Shall
for cleaning be deemed to have been achieved if, when tested in accordance with the methods described
in element 04, the specified test soil can be shown to have been removed completely leaving no
proteinaceous residues and the temperature of the in-flowing water in a pre-wash stage does not exceed
35°C.
for thermal disinfection, be deemed to have been achieved if, when tested in accordance with element 04,
the specified minimum temperature is achieved on all surfaces of the load and specified surfaces of the
Washer-disinfector chamber and load carriers for the specified minimum (hold) time.
include a rinsing stage which reduces the concentration of process chemicals on the products to a level
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C30 ELEMENT 02 PAGE 4
not exceeding that specified by the manufacturer, or supplier, of the process chemical(s) as safe in the
context of the intended use of the products.
where drying is required, have air of a quality which will not impair the standard of cleanliness or
disinfection achieved by the process prior to drying.
where drying is required, produce a visibly dry load/instruments at the end of the process.
8.0 Washer Disinfector Performance
Shall:be considered acceptable if it fully complies with the test requirements itemized in section 04 and section
D.
be considered unacceptable if it fails to satisfy any of the tests, thus requiring all faults to
be corrected and all tests to be repeated within the tender price prior to the unit(s) being
accepted.
enable the Purchasing Authority to instruct the Contractor to remove the unit(s) on
grounds of non-compliance within the Conditions of Contract in the event of the unit(s)
performance remaining unacceptable three months after commencement of on-site
acceptance tests.
The cost of removing the machine(s), making good the fabric of the building and any alterations required
to accommodate an alternative machine(s) will be borne by the contractor.
The supplier will also be liable to reimburse the Trust any costs incurred by the Trust including but not
limited to the purchase price of the machine, personnel costs, independent contractors costs and
laboratory costs.
.
End of Element
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C30 ELEMENT 03 PAGE 1
TECHNICAL
03
01 Operating environment
Shall
be designed to perform in accordance with this Specification in environmental conditions within the range
5°C to 40°C and 5% RH to 80% RH.
02 Chamber Operational life
Shall
be designed to withstand 25,000/T operating cycles where T is the minimum operating cycle time in
hours, specified by the manufacturer.
03 Washer Disinfector Construction
Shall
comply with the requirements of BS EN ISO 15883 Part 1 & 2
comply with the Safety requirements of BS EN 61010-1 and BS EN 61010-2-45.
have all components and surfaces (internal and external) free from sharp edges, burrs etc.
04 Materials of construction
Shall
be selected so that the parts of the Washer-disinfector which come into contact with the load are
manufactured from materials which have corrosion and abrasion resistance properties not less than those
specified for the 304 series of stainless steel (BS EN 10088 part 1).
for all parts of the machine which come into contact with the water, chemicals and/or steam are able to
withstand the possible corrosive actions of these substances.
for the components of the system used to contain and dispense chemical additives be constructed from
materials which resist corrosion from acid, alkaline and oxidizing systems.
Note:
The wet and chemically aggressive environment within the Washer-disinfector will cause corrosion
and galvanic attack when dissimilar metals come into contact – a fact which should be taken into
account when choosing the materials of construction.
05 Safety Devices and Safety Features
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C30 ELEMENT 03 PAGE 2
Shall
include for the provision of a list of all safety devices together with their settings and methods of
adjustment.
be designed to fail in a manner which does not cause a safety hazard to personnel.
prevent a safety hazard being caused by an error in the control or indication system.
include over pressure safety valves fitted to protect components that may be damaged by inadvertent
high pressures. This includes any pressure vessel, e.g. the steam generator or compressed air reservoir,
used within the machine. The discharge from safety valves shall be terminated in a safe position and
include drainage arrangements where appropriate.
06 Frame and panels/fascia
Shall
be provided with means to compensate for irregular floor surfaces. Floor mounted Washerdisinfectors shall be fitted with adjustable feet.
be finished smooth, with an easy to clean surface of an equivalence to 304 series of stainless steel (BS EN
10088 part 1). Specific fascia panel materials to be provided as specified in clause D11.
give due regard to the means of access for component maintenance and general cleaning.
Panels shall be easily removed and re-installed but not without the use of a tool or key and properly
secured.
07 Chambers/Cabinets (Type 1 and Type 2)
Shall
be constructed to ensure that they are self draining and free from sharp internal corners which cannot be
cleaned during the normal cleaning cycle.
be tested by visual examination after an operating cycle has been run on a chamber artificially
contaminated with a test soil (see element 04). There shall be no visible pools of water and no residual
soiling.
when filled to the designed maximum level with water shall not leak.
be provided with a means to enable temperature sensors to be inserted into each of the chambers by
means of a dedicated thermocouple entry connection as described in BS EN ISO 15883:1 ¶5.1.11.
be fitted with a removable screen, filter or equivalent in the chamber drain.
08 Multi/Sequential Chambers/Cabinets including tunnel type (Type 2)
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C30 ELEMENT 03 PAGE 3
Shall
have doors, or other systems fitted between adjacent chambers to prevent transfer of contamination
between consecutive chambers (or consecutive cycle stages with respect to continuous process tunnel
types) except insofar as this may be present on the load which is transferred between chambers prior to
completion of disinfection stages of the process
be able to perform the required parts of cycle in each chamber as detailed in clause D12.
specify limitations of particular chambers/cabinets when returning the tender (e.g. if the final chamber
can only operate in the drying role).
when designed without doors, incorporate a means to prevent the operator gaining access to the load
during a normal process cycle before its completion.
when designed without doors, incorporate a means to prevent the escape of fluid (liquids, aerosols and
vapours) from the Washer-disinfector during a process cycle.
09 Door(s)
Washer-disinfectors may have a single door or a door at each end (double door or pass
through machines).
If hinged doors are specified it should be clearly stated whether they are to be hinged on the left
hand side, the right hand side or horizontally hinged. Damper systems should be considered when
using horizontally hinged doors.
be configured for opening as specified in clause D13
have control, operation and safety of the door(s) fully complying with BS EN 61010, BS EN ISO
15883.
have seals designed to be easily replaceable and facilitate cleaning the contact surfaces of the door seal
without removing parts of the Washer-disinfector.
incorporate a device to ensure that the door can not be opened until the cycle is complete.
when a fault is indicated the door shall only be able to be opened after the Washer-disinfector has
been returned to a safe condition and then only by use of a key code, or tool,
have means provided to prevent a new operating cycle being started, should failure in any part of the
door interlock system occur .
prevent the operating cycle from being started until the doors are closed and/or locked.
10 Control of doors of a double-ended Washer-disinfector
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C30 ELEMENT 03 PAGE 4
Shall
where doors are fitted, have the door (loading or unloading) control initiating the automatic cycle as
specified in clause D13 of this specification.
Options include one end only or both ends with key/code interlock for unloading side.
ensure that when the loading door is closed and locked, it shall not be possible to open the unloading door
until the Washer-disinfector has completed a successful operating cycle – i.e. without showing a fault. If a
fault develops, it shall only be possible to open the loading door.
ensure that it is not possible for more than one door to be open at one time.
provide a visual display at both ends of the Washer-disinfector to indicate the stage of the cycle in
progress.
ensure the “cycle complete” indication or an equivalent indication, shall be cancelled when the unloading
door is unlocked, and the loading door shall remain locked until the unloading door has been locked
again.
11 Manually Operated Doors
Shall
have provided for the operator, an explanation of the manual action required to lock the door. In addition,
if the unlocking procedure is not the reverse of the locking procedure, there shall be an indication to the
operator of the manual action required to unlock the door. The indication shall be clearly displayed either
on the door or on its handle or handwheel. Explicit instructions shall be displayed on the facing panel
adjacent to the door or on the operator’s control panel.
have a mechanism such that the force to be applied by an operator in order to either lock or unlock the
door does not exceed 250N at the intended point of grip.
12 Internal doors and access ports
Shall
comply with the requirements of IEC 1403. This applies to doors fitted between consecutive sections of a
multi-section machine and access ports fitted to the outside of the machine for maintenance purposes.
13 Air Compressors
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C30 ELEMENT 03 PAGE 5
A compressed air supply may be required for the operation of controls, valves, door systems
and/or for use during the drying stage of the Washer-disinfector cycle.
Consideration should be given to providing back-up and stand-by compressor
facilities/arrangements. This may be achieved by using air supplied from suitable piped air
systems that incorporate standby facilities (quality withstanding) or the linking of pipework on
individual compressors via a change over valve.
Shall
be provided as part of the Washer-disinfector equipment if specified in Clause D14.
be suitable for the duty imposed upon them.
have components of the compressed air system which require servicing and maintenance, such as dryers
and filters, located where they are readily accessible for service or exchange.
14 Air Quality
Shall
be oil-free (i.e. should have no more than 0.5mg of oil per cubic metre of free air measured at 1013 mbar
and 20°C; see ISO 554) where it could come into direct contact with the load, such as when used for
drying the load or testing the free-passage of lumens. It shall be filtered to an efficiency of at least 95%
when tested in accordance with BS 3928 and be free of bacteria (see HTM 2022 ‘Medical gas pipeline
systems’).
for control purposes be free of liquid water, filtered to 25 µm (5 µm for precision controls) and
lubricated with micro-fog oil particles of 2 µm or less.
15 Integral Calorifiers/Heat Exchangers
Shall
conform to BS 853: 1996 and BS EN ISO 158883 ¶5.3 and be designed and constructed to allow thermal
disinfection to be achieved throughout the calorifier/heat exchanger and associated pipework before water
and/or steam can be supplied to the Washer-disinfector during the thermal disinfection and subsequent
stages.
16 Pipework and fittings.
Shall
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C30 ELEMENT 03 PAGE 6
be in accordance with BS EN ISO 15883 and ISO 228-1where applicable and be designed to allow the
removal and maintenance of individual components and sections of pipework without distortion of any
associated equipment.
be of a type that has been demonstrated not to support the growth of Legionella pneumophila when nonmetallic materials are used for conveying water or aqueous solutions. WRc water fittings and materials
directory should be consulted to identify approved products.
be resistant to `de-zincification' when fittings, valves and other components manufactured from copper,
gunmetal, bronze or similar materials which are intended to come into contact with water or aqueous
solutions are used.
when used to transport high purity rinse water (such as RO or distilled) be of suitable material
recommended by the manufacturer of the water purification equipment.
be clearly identified, by colour coding and written legend, with the nature of the fluid which it is intended
to carry. This colour coding shall be in accordance with BS 1710 1984.
each valve shall be clearly identified with a legend describing its function or with a unique code from
which its function may be determined by reference to a Pipework and Installation Diagram (PID)
be provided with means to ensure either that :
a) all pipework, fittings etc are free draining so that when not in active use all tanks,
connecting pipework etc can be drained dry, or
b) those parts that cannot be drained can be subject to thermal disinfection
17 Steam supply Pipework
Shall
include a pressure reducing system with a separator on the high pressure side. The system shall be
fitted with a strainer and trap to prevent condensate accumulating in the system.
18 Water Tanks
Shall
be self draining and located so that they are cleanable by the operator and fitted with a drain down system
which either works automatically when the machine is switched off or which is accessible to the user.
be fitted with an overflow and have wherever necessary, a removable and cleanable coarse filter to
filter re-circulated water.
19 Heating Sources
Shall
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C30 ELEMENT 03 PAGE 7
employ heating mediums as specified by clause D15.
be fitted with a temperature controlling device.
be removable for replacement or maintenance purposes.
incorporate one or more over-temperature cut-out, capable of being manually reset, to protect the load
from exposure to excessive temperature.
20 Test Tees
Shall
when pressure vessels are fitted include branches to every pressure gauge for the insertion of test
gauges. Tees to be provided with leak-proof blanking off plugs and valves.
21 Instrumentation – general
This specification does not preclude the use of microprocessor-based instruments and control systems
providing the integrity of the safety systems is not prejudiced and information is not corrupted or lost.
Shall
be such that the location of all sensors, whether connected to the controller or the independent process
recorder, is appropriate and provides data which can be correlated to conditions throughout the chamber
and load.
where more than one gauge or instrument is fitted in the same area, be of a uniform appearance. As an
alternative to discrete instruments any or all of the required displays may be provided by a single
display unit.
For illuminated displays, the minimum character size shall be determined in accordance with BS EN
60073 for a viewing distance of up to 1 metre. For non-illuminated displays, e.g. LCD, the character
height shall be not less than 10mm. Displays shall be mounted in such a manner that they do not reflect
light to impair vision. Error messages (faults) shown on VDUs to be in an easily distinguishable form,
not in normal display.
be supplied complete with all necessary power supplies, software, sensors and recording devices.
22 Temperature Indicators
Shall
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C30 ELEMENT 03 PAGE 8
ensure that the temperature of the water supplied to, or in, each calorifier/heat exchanger, water tank,
process chamber and the temperature of the air supplied to the chamber is indicated b y means of a
temperature indicator.
conform to the types listed below:
Type A : Dial type expansion thermometers, liquid or gas filled.
Type B : Indirect electrical indicator instruments.
Type C : Indirect electrical indicator/controllers using digital techniques, and
with analogue or digital display.
Range: 0 – 150°C
Accuracy ± 1% over range 0°C to 100°C
Resolution 0.1°C or better
incorporate a means of zero adjustment for setting on site, so arranged that authorised persons can
make the adjustment without having to remove the instrument from its case or dismantle the
instrument.
have characters legible with corrected or uncorrected vision from 25- 1000mm distance for the indicator
in an ambient illumination of 200-400 lux.
23 Measurement Systems (Including control, monitoring and recording)
The minimum performance characteristics of the measurement systems shall meet or exceed the
following requirements:
Temperature Range
0°C to 150°C
Accuracy
± 1% over range 0°C to 100°C
Resolution
0.1°C or better
Sampling rate at least every 2.5 seconds
When fitted with cold junction compensation, the error shall be not more than .08°C/°C rise in ambient
temperature.
Pressure Range
100kPa to 1000kPa
Accuracy
± 2% over range 100kPa to 500kPa
Resolution
1kPa or better
Sampling rate at least every 2 seconds
Volume/flow Range
0% to 150% of theoretical maximum flow (or volume) at
the sensing point
Accuracy
± 5% of full scale
Resolution
± 1% of full scale
Sampling rate at least every 5 seconds
Temperature compensation 0°C to 95°C
Shall
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C30 ELEMENT 03 PAGE 9
incorporate a means of zero adjustment for setting on site, so arranged that authorised personnel can
make the adjustment without having to remove the instrument from its case or dismantle the instrument.
Note:
A common sensor may be used for the indicator and controller whenever an
independent monitoring and recording system is fitted.
24 Independent Monitoring and Recording Systems (Process Verification)- General
Shall
be fitted to monitor and record the key variables of the operating cycle.
be traceable to the production/batch load and/or loading basket.
unless otherwise specified in clause D16, monitor and record the variables listed below:
-
the temperature of water and air in each chamber at each stage in the operating cycle
-
the volume of each chemical additive admitted, and the time at which it was admitted, at
each stage in the operating cycle
-
the pressure and/or flow of water/aqueous solutions supplied to the chamber during
washing and rinsing stages
including sensors, amplifiers and A to D (Analogue to Digital) converters, be independent of the control
system and have an accuracy, resolution and response time not worse than the performance specified in
clause C03.23.
if specified in clause D16, provide a clear indication when process variables are outside the set limits
previously validated either by means of independent alarms or through an appropriate interface with the
control system. Where two or more Washer-disinfectors have linked independent monitoring systems the
failure of the system shall not prevent the operation of two or more of the Washer-disinfectors.
provide a visual display in real-time to the operator during the operating cycle either locally or via a
remote Personal Computer.
if required as specified in clause D16, record the data electronically in a format suitable for periodic
transfer to a Personal Computer. The data storage system shall hold sufficient data to record the data from
not less than 5 days of continuous operation of the Washer-disinfector and incorporate facilities for backup and security of stored data. The manufacturer to supply documentation, sufficiently descriptive, of the
interface and file protocol requirements to permit the transfer or to supply a complete software system for
viewing, storing and analysis of the data.
unless otherwise specified in clause D16 have its display located on the clean (unloading) side of the
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C30 ELEMENT 03 PAGE 10
Washer-disinfector.
25 Independent Monitoring and Recording Systems (Process Verification)– Hard Copy Print Out
Shall
be either a chart recorder, digital printer or both whenever specified in clause D17.
if a chart recorder is specified, be provided with strip charts not less than 90mm wide and scaled from left
to right for increasing variables. The scale of the chart to be used should enable all variables to be plotted
to at least maximum alarm values.
include timers with an accuracy of ±2.5% for periods up to 5 minutes and for periods above 5 minutes of
at least ±1%. This shall also apply to the recorder chart speed and digital printouts.
if a printer is specified provide for hard-copy print-out from data which has been taken from a sampling
rate for each channel of pressure of at least 2 second intervals and for temperature for each channel of at
least 2.5 second intervals. Print out to occur as the cycle proceeds or at the end of cycle and include for
faults to be printed.
be fascia mounted or the alternative specified in Clause D17, the tenderer to state the
interface type.
include the following control command facilities: list, form feed, line feed, carriage return, print,
inverted print, expanded print and either multi-colour or multi-emphasis print quality.
remain legible for 10 years after printing when stored at normal room temperature and able to be
photocopied.
be traceable to the production/batch load and/or loading basket
have a self test facility incorporating line feed.
produce a printed record of line length specified in Clause D17 or if not specified a minimum width of
40 characters.. Characters not relevant to the specified data to be omitted.
produce a printed record which, when illuminated within the range 200 lux to 400 lux and viewed
with normal or corrected vision, will be clearly legible at a nominal viewing distance of 25cm.
incorporate a "wind-on" spool if specified in Clause D17.
26 Verification of Calibration of Test Instruments
Shall
comply with BS EN ISO 15883 ¶ 5.11, 5.14, 5.15.
27 Control systems - General
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C30 ELEMENT 03 PAGE 11
Shall
be supplied complete with all necessary power supplies, software, sensors and recording devices.
where the Washer-disinfector has the capability to electronically transfer data direct to the manufacturer,
provide a facility for the client to review such data.
be supplied complete with evidence that any software used to control the machine has been produced in
accordance with a formal documented quality system and then subjected to a formal validation
programme.
shall provide evidence that the complete programme and software for machines controlled by a microprocessor has been lodged with an independent body together with instructions. In the event of the
supplier ceasing to trade or failing to attend to software related problems, or defect/hazard investigation,
the purchaser shall then have access to the programme and software. Details of this independent body
shall be submitted with return of tender clause D34
when a microprocessor is used to control or monitor the process, separately document the values of
cycle variables critical to process performance and determined during validation, regardless of
whether or not they are held in the microprocessor memory.
display the version number of the software used in the microprocessor when required.
28 Microprocessor Systems
Shall:be discrete for each Washer-disinfector and with each Washer-disinfector separately isolated.
be completely separate from central processors controlling other operations such as a building energy
management system.
include for all controls, transducers, indicators and instruments to function correctly in ambient conditions
described in Clause 03.01 of this Specification. The Contractor to pay due attention to the location of
controls and cycle start units and ensure that they are not sited where they will be affected by heat or
moisture. The instrumentation and controls to be located clear of the area above the Washer-disinfector
door or chamber.
have the automatic control sequence initiated by a single action by the operator with only one single
action start position on each Washer-disinfector. Where a bar code or batch code entry system is provided
the cycle to remain inactive until a valid code is entered.
include facilities to enable appropriate sensors, control items and stages of the process to be temporally
disabled during validation so that the full requirements of BS EN ISO 15883 can be met.
at all times maintain safe conditions within the chamber and be arranged such that in the event of a failure
it will not cause a safety hazard.
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C30 ELEMENT 03 PAGE 12
have means to ensure that the microprocessor sensor(s) and timing devices are functioning correctly
and provide a fault indication when this is not so.
incorporate at least two timing systems independent of each other when combined control and
monitoring systems that are wholly operated by means of a microprocessor are used.
be arranged for safety devices requiring power sources to be independent from the processor.
where the operating sequence of the unit is controlled by measurement of process values and where the
attainment of such values may effect the safety of the machine or the effectiveness of the process, ensure
that such measurements be determined from more than one sensor when independent monitoring
(process verification) systems are not fitted.
where the measured values from such sensors differ by more than one preset level initiate a fault
condition.
provide serial advance through a sequence of stages. The stage in process to be legend-displayed
in words on the front fascia panel.
be mounted in a finger proof protective case accessible by means of a suitable key, code or tool. Where
necessary to maintain a constant internal environment, the case to be ventilated by means of a fan via
coarse filter.
have fixed labels on the case giving all necessary warnings concerning the isolation of services.
have connections from the processor unit to each hardware peripheral component (e.g. printer, disk drive
etc) via a suitable identifiable connection plug and associated socket complete with identification to
ensure correct connection.
except for items associated with sensors, provide for the programmable controller to contain all the
components necessary for its function together with a watch dog system for the safe operation of the
process. (See Part 2 of Programmable Electronic Systems in Safety Related Application, paragraph 199.)
have means to prevent damage to the microprocessor in the event of over-voltage being applied through
the input and output connections. Each input and output to include a means to check, at commencement
of cycle, all peripherals and inputs and outputs are connected and not identifying faults. This may be a
simple indicator (e.g. LED) or a more sophisticated alarm system built into the microprocessor.
have internal Timers/Counters fully programmable and interlocked for single purpose access.
have the memory module/cards, when used for programme storage utilizing non volatile memory. If this
is achieved by means of a removable rechargeable battery incorporated on the circuit board connections
of the solderless type to be used. A change back-up battery status and an indicator to be provided on the
front fascia panel showing state of charge. The battery backup should be positioned to allow easy access
for changing batteries.
incorporate an operational mode feature allowing the Maintenance and Test Engineer to override the
programme with additions, deletions and corrections which, when completed, make no change to the
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C30 ELEMENT 03 PAGE 13
permanently programmed cycle. Access to this feature to be by code or key.
have counter-measure against power failure such that should a power failure occur during a
cycle the programme will either:(a) where cycle efficacy and safety conditions are not jeopardised, hold the cycle at the point
of failure, memorise the elapsed status of the counters and times and resume the cycle when
power is restored;
(b) when power is restored the cycle to terminate in a safe condition, a failed cycle be indicated, and the
door interlocked to restrict access to an authorised person only.
ensure that where the sensing element of any safety system involves an electrical switch, there be no
other contacts or circuits of any sort in parallel with the switch whereby, either during normal
operating or malfunction, power could by-pass the switch. Equivalent principles to produce the same
effect to apply in the case of non-electric systems.
perform as designed when subjected to electromagnetic or electrostatic interference as specified
in BS EN 61326.
be fitted with suppression equipment to reduce mains transmitted interference voltages to within the
limits stated in BS EN 55014:1993.
29 Communication Port and Interfaces
Shall
be provided for the following:(a) input of programme;
(b) input to effect changes to registers holding parameters;
(c) interrogation of registers holding parameters;
(d) input of signals for calibration tests;
(e) a Building Management System if specified in Clause D20.
if specified in Clause D19, comprise a fascia mounted port and interface with the logic unit for a bar code
reader. The device to employ the specified numbering system for identifying the types and quantities of
load items being processed and transfer the interpreted bar code characters in alpha-numeric codes to the
printer and storage device (if specified) to give a hard copy of the codes which have been read when the
Washer-disinfector is loaded. The bar code reader to be operable only when the Washer-disinfector is
being loaded.
30 Cycle Counter
Shall:be a tamper-proof or sealed 5 digit counter to indicate the cumulative total of cycles started and be
visible to the operator.
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C30 ELEMENT 03 PAGE 14
31 Dosing Systems
Shall
consist of not less than two systems for controlling the admission of chemicals (detergents and/or rinse
aids and/or lubricants and/or neutraliser.) and be provided with the facility for at least one additional
dosing system to be fitted at a later date. If more than two are required the number of dosing systems may
be specified in clause D21.
be provided with means to adjust the volume admitted. Access to the means of adjustment shall
require the use of a key, code or tool. The means of adjustment can be manual or automatic.
be provided with means to determine the volume admitted and the time within the operational cycle when
the admission occurred. This data shall be available to the operator in order to verify the amounts of each
chemical used per cycle. Indication to the operator may be either manual or automatic.
cause a fault to be indicated on failure to admit the specified minimum volume.
have specified the accuracy and reproducibility of the control of volume admitted for each of the dosing
systems used per cycle. This shall be appropriate for the volume of additive required for each stage of
the process.
prevent operation of the Washer-disinfector or cause an alarm to be given when there is insufficient
chemical for completion of a further process cycle.
be under the control of the automatic controller with respect to the stage(s) in the process cycle at
which each dosing system admits chemical to the Washer-disinfector.
have stated the recommended method of cleaning all injection lines and valves.
be supplied integral or attached to the Washer-disinfector (complete with all pipework, pumps and
couplings) for extracting the chemicals from supply containers (carboys). Or be supplied integral or
attached to the Washer-disinfector (complete with all pipework, pumps and couplings) for extracting the
chemicals from a bulk tank system located as specified in clause D21.
have mechanisms for delivery and operation of chemical additives in accordance with Control of
Substances Hazardous to Health Regulations 1999 (COSHH) and keep additives free from contamination
and prevent mis-use.
have mechanisms for replacement of chemical additives that minimises manual handling in accordance
with the Manual Handling Operations Regulations 1992.
32 Load carriers
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C30 ELEMENT 03 PAGE 15
Shall
be provided to locate the load during the washing and disinfection process.
facilitate as far as is practicable the processing of instrument sets as a unit.
if interchangeable load carriers/baskets are provided, be capable of being fitted and removed from the
Washer-disinfector without the use of tools and be interchangeable between Washer-disinfectors where
practicable.
when the load carrier is designed to provide channels or pipework to permit the flow of fluids and drying
air to the internal surfaces of attached load items, or to spray arms, be of a design and construction that
ensures that the total flow is distributed in the proportions required to optimise the cleaning, disinfecting
and drying processes. Where successful attainment of cycle parameters is dependent upon the correct type
of load carrier being selected, the Washer-disinfector shall incorporate a means for detection of the
correct type of load carrier.
be such that they are self-cleaning and the free-flow of water to the drain not being obstructed.
be constructed in a manner which ensures that the surfaces of the carrier are cleaned during the normal
operation of the Washer-disinfector. This shall be tested by visual examination after an operating cycle
has been run on a carrier artificially contaminated with a test soil (see enclosed test methods). There shall
be no residual soiling.
ensure that the load is wholly supported and retained within the usable chamber space for the duration of
the operating cycle. The force required by the operator, either directly or by the application of a
mechanical device supplied with the equipment, to remove the whole, or part, of the load from the
chamber shall not exceed 250Newtons when loaded and operated in accordance with the manufacturer’s
instructions.
either be retained in the chamber by a mechanism which is only released when the transfer system is in
place, or remain stable when withdrawn for a distance equal to two-thirds of the chamber length, and be
fitted with a retaining device, which has to be released if the load is to be withdrawn further.
be provided with a means such that the transfer of the load into and out of the chamber does not cause
damage and wear to the chamber. The system used to support the load shall be constructed from
durable, corrosion-resistant materials and should withstand, without damage, the environment within
the chamber.
be provided that allow tray contents to be kept together and facilitate processing of cannulated
items within the same cycle/batch as other instruments within the set.
be designed with regard to the Manual Handling Operations Regulations 1992.
33 Load Transport Systems (Conveyors)
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C30 ELEMENT 03 PAGE 16
Shall
be supplied as specified in clause D23 to transfer loads into and out of the Washer-disinfector and consist
of, as specified in clause D23 either in-feed conveyor, exit conveyor, or both.
allow for carriages to be returned to the loading side by means of a return conveyor if specified in clause
D23
Note:
It is recommended that return conveyors shall pass through a transfer hatch, built into the wall
between the packing room and the decontamination room, and include means to minimise the
passage of air directly between the packing room and the decontamination room. The design and
construction of the pass through hatch shall ensure that positive pressure is maintained in the packing
room during the transfer of load carriers through the hatch.
Door(s) fitted to the transfer hatch shall be transparent or shall include viewing ports. These shall
be made of safety glass or of a scratch resistant non-breakable transparent polymer.
if specified in clause D23, incorporate a transverse conveyor on both the loading and/or unloading side to
permit transfer of load carriers between Washer-disinfectors and between Washer-disinfectors and the
return conveyor. Between adjacent machines a section of the transverse conveyor shall be hinged to allow
displacement for access to the Washer-disinfectors
not require the operator to lift the loaded or unloaded carrier once it is on the conveyor to effect the
transfer, whether a powered or unpowered system is used.
be constructed to facilitate cleaning.
not transfer lubricants to the carrier passing over it.
be designed and manufactured to allow the parts of the conveyor coming into direct contact with the
load carrier to be de-mounted, thoroughly washed and either sterilised in a porous load sterilizer at a
sterilization temperature of 134 +3 –0°C for 3.5 minutes or thermal disinfection via a Washerdisinfector.
if specified in clause D23, provide a drip tray under the conveyor on both the loading and/or unloading
side of the Washer-disinfector.
This drip tray shall be continuously sloping to a discharge point connected to a drain of not less than 40
mm diameter. There is a need to avoid contamination of drip trays and consideration should be given to
the drainage arrangements. Advice can be sought in HTM 2025.
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C30 ELEMENT 03 PAGE 17
34 Tabling
Shall
If specified in clause D24 manufacturers shall provide details of appropriate tabling that is compatible
with the Washer-disinfector and loading system specified.
be constructed from materials providing a corrosion resistance not less than that afforded by 304 series of
stainless steel (BS EN 10088 part 1).
35 Transfer Trolleys (carriages)
Shall
be provided with the Washer-disinfector as defined in clause D25, each designed to accommodate one
load carrier.
be provided with means to retain the carrier in position when the trolley is being moved for example
during transfer from the carrier storage area to the loading area or the Washer-disinfector.
be provided with not less than one pair of swivel wheels to facilitate steering and provided with foot
operated parking brakes on the pair of wheels nearest to the operators position.
be constructed from materials providing a corrosion resistance not less than that afforded by 304 series of
stainless steel (BS EN 10088 part 1).
remain stable when supporting their maximum design load and a force of 250Newtons is applied
horizontally in any direction to the highest point of the load or accessory.
be provided with means to collect liquid residues from the load to prevent these from dripping onto the
floor. The means provided shall be detachable for cleaning and for either sterilization at 134 +3 –0°C for
3.5 minutes in a porous load sterilizer or thermal disinfection via a Washer-disinfector.
be designed to secure the load carriers on the trolley during loading and unloading, and while
traversing a gradient at a slope of up to 1 in 20.
if intended for use with single door machines, be designed and constructed to facilitate cleaning
and disinfection of the trolley between use for dirty and clean loads.
If required in section D25 be provided with means for storage of spare load carriers when not in use and
means of transfer for spare load carriers from storage to operational use. This shall not require the
operator to lift the load carrier.
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C30 ELEMENT 03 PAGE 18
36 Maintenance Access
Shall:be such that all parts requiring servicing are easily accessible and where the Washer-disinfector is
enclosed in a cabinet, be so designed that all panels are easily removable for maintenance purposes.
for double door Washer-disinfectors be from the loading side wherever possible.
be constructed as to enable changing components without dismantling other, unconnected parts of the
machine.
37 Electrical Supply, Wiring and Switchgear
Shall
be via one electrical connection to the machine complete with all internal electrical wiring.
shall include earth leakage detection and be fitted with a low impedance earth of less than 0.1Ω over the
measurable loop..
have earth connections on removable panels, complete with sufficient flex to enable the panel to be
removed via an identifiable conductor (not reliant on a hinge or the panel screw).
be designed to operate with an electrical supply provided with means to isolate all poles simultaneously
from the mains supply. Each pole shall be fused separately.
include an accessible means of emergency isolation provided on the front fascia of the Washer-disinfector
for single door machines and on both loading and unloading sides for double door machines.
such that all individual switches on the outside surfaces of the Washer-disinfector have an IP rating of 44
when tested in accordance with EN 60529 : 1991
have the control/indicator panel designed to be resistant to the ingress of water, steam and/or condensate
during normal operation of the machine
have switches provided for start i.e. cycle commence and for cycle selection.
be marked with an appropriate symbol and labelled with a description of the function which is legible at a
distance of 1 m from the machine.
Note:
These switches may be combined with the indicators shown in IEC 73.
The symbols to be used shall conform to the requirements of IEC 417 and/or ISO 7000.
When new symbols are defined these shall be designed in accordance with the
requirements of IEC416.
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C30 ELEMENT 03 PAGE 19
if specified in clause D26 incorporate a waterproof (IP44 rated) RCD protected 230V 13A double socket
outlet mounted on the fascia of the Washer-disinfector for connection of test instrumentation.
38 Ventilation Systems and Ductwork
Shall
be supplied as specified in clause D27 either as:
(a) a fan and ductwork system connected to an existing duct terminated to within 2 metres of the Washerdisinfector(s)
(b) a complete system terminated outside of the building at high level away from opening windows and
air conditioning intakes.
consist of a stainless steel or plastic ductwork system with a fan and water condenser (if necessary)
provided by the manufacturer to prevent vapour entering the working area.
be capable of withstanding the atmosphere within the Washer-disinfector.
keep the interior of the Washer-disinfector at negative/neutral pressure to the surrounding air during
operation and comply with the guidance given in BS EN ISO 15883 ¶5.24
have the fan fitted as close to the outlet to atmosphere as possible, in order to keep the majority of
the ductwork under negative pressure.
have a suitable discharge cowl fitted on the outside of the building at high level away from opening
windows and air conditioning intakes.
have the total length of ductwork of sealed construction and not spiral wound, and of the same
material throughout its length.
where fans are required, use fans constructed of a material suitable for use in environments
containing moisture laden air.
where the ductwork runs horizontal, have a gradient sloping down towards the Washer-disinfector to
allow water to drain back. Suitably positioned drains shall be provided on the ductwork, if necessary,
to avoid water ‘ponding’. They shall be fitted with correctly sized water seals.
comply with the guidance given in BS EN ISO 15883 ¶5.24
incorporate visual indication on the Washer-disinfector indicator/control panel to demonstrate that the
remote fan is either operating or in a failed condition.
where required in clause D27 provide an interlock to prevent operation of the Washer-disinfector
when the fan is not operating/running.
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C30 ELEMENT 03 PAGE 20
39 Water supply
Shall
if specified in clause D28, include in the tender, separately priced, the cost of providing water softening
plant and the required final rinse water treatment plant to satisfy the requirements of clause D28. This
shall include installation and commissioning costs.
Note: The following table defines the quality of water that should be used in Washer-disinfectors:Determinand and Unit
Appearance
Degree of acidity [ph]
Conductivity at 25 C [µS/cm]
Total dissolved solids [mg/100ml]
Total hardness, CaCO3 [mg/l]
Chloride Cl [mg/l]
Heavy metals determined as Lead, Pb
[mg/l]
Iron Fe [mg/l]
Phosphate P2O5 [mg/l]
Silicate SiO2 [mg/l]
Total viable count at 22 C
at 37 C [cfu/100ml]
Bacterial endotoxins [EU/ml}
Maximum permitted values
Final rinse
Other processes
Clear,
colourless
5.5 to 8.0
30
4
50
50
10
120
10
2
0.2
0.2
100
100
0.25
-
N.B For Washer-disinfector’s in which a product is rinsed after the disinfection stage the TVC
should be 0cfu/100ml.
Though the Washer-disinfector manufacturer may not have specific water quality
requirements for the equipment itself, the manufacturers of the instruments and medical
devices processed through it may do. These requirements should be considered when
specifying water quality.
where this specification includes provision of a final rinse water treatment plant, incorporate a means to
ensure that the chemical and microbial quality of the final rinse water is maintained at a level which will
not impair the standard of cleanliness achieved by the process prior to rinsing.
include provision to monitor the attainment of this water quality either continually or as a periodic check
by the operator (as a minimum a sampling point shall be provided).
the means to be provided will depend on the nature of the controls employed but may include
conductivity of in-flowing water as an indication of chemical purity and temperature at which the water is
maintained as an indirect measure of microbial quality. The specific monitoring and measurement
arrangements required shall be as specified in clause D28.
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C30 ELEMENT 03 PAGE 21
obtain samples or analysis of water supply at site to ensure that equipment supplied will meet the
output requirements.
if reverse osmosis plant is specified be capable of providing water of less than 30µS/cm at 25°C and
designed/constructed in a manner that prevents growth of bacteria in the treated water system (e.g. recirculating loops and/or heated to above 60°C immediately after generation).
provide for sampling points before and after each item of water treatment plant to facilitate testing.
state space requirements for any remote water treatment plant within the return of tender, with any
such plant being positioned so as not impede work activity.
include for all water services and associated equipment to comply in all respects with the Water
Supply (Water Fittings) Regulations 1999.
Note:
Your attention is drawn to Part 2 regulation 5 concerning “notification to undertake
work” and to schedule 1 “fluid categories”
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C30 ELEMENT 03 PAGE 22
40 Noise Emissions & Sound Power
Note:
The perceived level of noise in the immediate vicinity of the Washer-disinfector during operation is of
concern. In the HSE Noise at Work Regulations (1989) there is a Legal requirement as an employer to
prevent damage to the hearing of workers. Action needs to be taken if noise causes risks other than
hearing damage, or creates risks to other workers, for example, if the background noise reduces the
audibility of a warning sound. The perceived noise level depends not only upon the sound power
level of the equipment but also on three major noise control principles:
a) Absorption
b) Insulation
c) Isolation.
These must be determined with the Washer-disinfector installed and working normally.
There are three action levels defined in the Noise at Work Regulations (1989).
a)
The First Action Level a daily personal noise exposure (LEP,d) of 85 dB(A)
b)
The Second Action Level - a daily personal noise exposure (LEP,d) of 90 dB(A)
c)
The Peak Action Level - a peak sound pressure of 200 Pascals (140 dB re 20 mPa)
All daily personal exposure levels are based on an 8-hour working day. Where the normal daily
working hours exceed this figure, advice should be taken as to the exposure levels.
Shall:using the procedure described in clause 8.1 of BS 4196 Part 6, whilst the Washer-disinfectors are
operating, for both the loading and unloading areas if these are not common, determine the following;
a) the daily personal noise exposure (LEP'd)
b) the peak sound pressure level.
the test should be considered satisfactory, if the following requirements are met :a)
the daily personal noise exposure
i) 55dBA for a Washer-disinfector installed in an operating suite, ward, treatment room or
other noise sensitive area:
ii) 70 dBA for a Washer-disinfector installed in a sterile services department
b)
in both the loading and unloading area the peak A weighted sound pressure does not exceed
the daily personal noise exposure
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C30 ELEMENT 03 PAGE 23
be the manufacturer’s responsibility to carry out any modifications to the Washerdisinfector(s) resulting from the failure of the above assessment.
comply with BS EN ISO 15883.
41 Thermal Emission, Surface Temperatures and Insulation
Shall:ensure that no surface exceeding 55°C is exposed to the room when the machine is closed and working
under its normal operating conditions.
where practicable, have all pipework lagged with sectional lagging. Sectional glass silk is excluded
for these purposes.
consist of materials which are non-flammable and heat resistant which, when applied, allow for any
access to all components for maintenance purposes. Asbestos is excluded for these purposes.
42 Manufacturers Installation
Note It is strongly recommended that the successful bidder meets with the purchaser to discuss their
particular installation requirements. Minutes of such meetings should be kept and made available in
the event of dispute.
include responsibility for the installation of the machines including:
−
preparation of a detailed site plan prior to commencement of work,
−
approval and appointment of any necessary sub-contractors, and ensuring that they also operate
an appropriate quality system. Their manufacturing records and quality system documentation
shall be available for audit/inspection if requested by the client
− liaison with client for permission to carry out any necessary alterations to the fabric of the
building or its installed services,
−
if specified in clause D08, removal and disposal of the existing Washer-disinfectors,
−
preparation of the area to accept the new machines,
−
installation of the machines, conveyors and tabling
−
providing for all services (including but not limited to: water, steam, condense, drains, vents,
electricity and compressed air) to be installed from within 2m of the plant (valved off or
terminated by others). If any of these services are not available the Tenderer will be required to
provide equipment as specified in clause D30.
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−
C30 ELEMENT 03 PAGE 24
providing for all interconnecting electrical wiring, pipework, provision of valves, traps, pressure
reducing valves as required and anything necessary for the correct installation and testing of the
plant.
−
for the manufacture, supply and installation of fascia panelling and access doors as
specified previously in clause D11.
−
making good of the surrounding area.
−
manufacturers installation and validation tests according to BS EN ISO 15883 Parts 1 & 2 Annex
A.
43 Operating Instructions
Shall:be provided and fixed to the fascia panel and comprise a permanently marked notice giving clear and
simple operating instructions and stating the classes of articles which can be processed in each
individual cycle of the machine e.g. "surgical instruments", "anaesthetic accessories" or "hollowware"
etc as appropriate.
Shall:include for delivering the Washer-disinfector to site and off-loading from the delivery vehicle and moving
it to its final location, as defined in Clause D01, packing to be as defined in Clause D07.
45 Technical Documents, Manuals, and Other Documentation
Shall:be supplied upon delivery of the Washer-disinfector(s) and comprise three complete sets or a number
specified in Clause D06 of technical literature on the operation, maintenance and overhauling of ALL
items of equipment incorporated on the Washer-disinfector, together with two copies of record drawings
showing the pipework and installation diagrams, pneumatic, pipework and electrical circuitry of the
machine.
include record drawings of installation services and fascia panelling to be provided if specified in Clause
D06.
include spare charts, printer rolls, pens and printer ribbons as specified in Clause D09.
The literature to include a complete planned preventive maintenance programme showing the tasks to be
carried out at regular intervals compatible with the standard planned preventive maintenance intervals in
use in NHS Hospitals, which are:(a) weekly
(b) monthly
(c) quarterly
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C30 ELEMENT 03 PAGE 25
(d) half yearly
(e) yearly
(f) two yearly
include for the supply of an operational chart showing the detailed sequence of events and operating
parameters during a normal cycle and indicate what will happen at each stage or sub-stage of the cycle if
the parameter controlling that stage or sub-stage, e.g. level of water pressure, temperature etc is not
satisfied. For microprocessor-controlled machines the following programming features and menus to be
provided:(a) Door operation and cycle, start procedures.
(b) Door operation at the end of a cycle.
(c) Aborting a cycle.
(d) User's menu.
(e) Maintenance engineer's menu with optional mimic diagram.
(f) Operating security levels.
(g) Address lists, and values of process variables.
(h) Calibration of instruments.
(i) Interrogation of registers holding process variables.
(j) Input and output status at all stages.
(k) Diagrams to show the status of all inputs and outputs for each stage of the process.
list typical causes of failure during a faulty cycle and their remedy.
validation documentation including 3 bound copies of all installation and validation test results.
copies of all relevant certification and type approvals including calibration certificates for all instruments
fitted to the Washer-disinfector.
46 Training
Shall
be provided by the contractor as defined in clause D31.
take account of the mixed ability and capabilities of the personnel defined in Clause D31 and be
provided by the demonstrators/lecturers with substantial experience of the machines to be
demonstrated, the time required to provide this instruction to be stated in Clause D43 at the time of
tender.
include a documented assessment of the competence of staff that have completed the training to operate
and/or maintain the Washer-disinfectors correctly.
including assessment methodology and acceptance criteria, shall be documented in sufficient detail to
allow staff within the unit to repeat the training for new recruits.
during the defects liability period , be provided as detailed in the clauses above in respect of any upgrade
or modification carried out by the manufacturer that requires a change in either maintenance or
operational policy.
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C30 ELEMENT 03 PAGE 26
When requested in clause D31, manufacturers shall provide detailed costs of further advanced training
options.
47 Works testing, commissioning and performance testing
When specified in clause D32 as a requirement, the Manufacturer shall notify when the machine is ready
for works testing prior to shipment by giving not less than 14 days notice in writing. The manufacturer
shall provide all necessary facilities at their premises to verify that the machine meets the specified
performance requirements.
Note: Waiver of the works inspection; shall not be construed as acceptance of the machine. Whether or
not a pre-shipment works inspection and/or test is made the Manufacturer shall provide documentary
evidence of the tests carried out prior to shipment.
Shall:
take place after installation of the Washer-disinfector and include for fully commissioning the machine in
accordance with BS EN ISO 15883 Part 1 & 2 Annex A, and if specified in clause D32 undertake further
operational and performance qualification tests.
be witnessed by a representative of the Purchaser (e.g. Authorised Person (Sterilizers) [Authorising
Engineer (Decontamination)]) as specified in Clause D32. Where a client representative has been
nominated all validation documentation shall be available for audit prior to acceptance of the
machine(s) by such persons.
be arranged by the manufacturer with at least 14 days clear notice to be given of the planned date of test.
Any expenditure involved as a consequence of the manufacturer cancelling the arranged date for
witnessing the tests will be met by the manufacturer.
be undertaken with any device or equipment required for the purpose of conducting the
commissioning/routine tests being provided by the manufacturer.
be undertaken using test loads supplied by the manufacturer if specified in clause D29. Any additional
costs involved for the provision of such equipment shall be clearly identified prior to contracting to
provide the machine.
be undertaken using only test equipment calibrated as recommended in BS EN ISO 15883 ¶ 6.2 and that
calibration is traceable to national standards.
48.0 Servicing and Maintenance
The manufacturer shall
specify the service time required to carry out all routine maintenance tasks and for the replacement of all
major components.
undertake service visits in accordance with the recommended planned maintenance schedule. The number
of visits included during the warranty period shall be documented in the return tender in clause D35.
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C30 ELEMENT 03 PAGE 27
submit a comprehensive, written, service report in respect of each service visit, giving full details of the
work carried out.
not change during servicing operational values of any of the variables established during performance
testing as critical to successful processing without the prior written consent of the purchaser.
on completion of the appropriate service, carry out the quarterly testing specified in Annex A BS EN ISO
15883 parts 1 & 2 to verify that the performance criteria established during commissioning remain valid.
in the event of a breakdown and at the request of the purchaser, provide a service engineer on site within
the response time requested by the client as specified in section D33.
hold a stock of all replaceable components, either at their premises or at the purchasers premises, for use
in the event of breakdown, for a period of not less than 7 years from the date of installation. These shall
be charged for only as and when they have been supplied and fitted.
provide a list of recommended service spares and consumable items for one year's use to be included and
priced in Section D43. The spare parts list shall be comprehensive with clear identification of those items
held in stock (i.e. available on site within 4 hours by courier delivery if required see above). The lead
times required for delivery of non-stock items shall be specified. Details of the quantity and frequency
with which each consumable item is required shall be included.
49 Throughput Profile – Output Performance Specification (Method 1)
Note:
If adopted, this approach requires tenders to be based on providing the full range of Washerdisinfector and ancillary equipment needed to meet the SSD throughput profile specified.
A detailed analysis of SSD wash throughput profile is necessary, usually complemented
by site visits from prospective tenderers to ensure all necessary fitments and attachments
are catered for and included in the tender. The onus to ensure all necessary equipment is
included for rests with the tenderer.
Tenderers may be required to give a presentation to the Purchaser on the merits of the
proposal and/or arrange a visit for approx. 3 Purchaser representatives to a site having
similar equipment in operation, with the Purchaser paying for all costs incurred by their
representatives in such a visit.
Shall
be in accordance with the required throughput profile specified in clause D01a.
o
be based on a disinfection temperature of 90 C, unless stated otherwise, and the machine validated at this
disinfection temperature.
include details and numbers of each type of carrier, fitment and wash basket proposed.
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C30 ELEMENT 03 PAGE 28
include suitable ultrasonic cleaning equipment necessary to ensure all items, particularly the difficult to
clean items are thoroughly cleaned.
detail arrangements for sonic irrigation of lumens.
include suitable arrangements/mechanisms for the drying of the load.
offer a solution that enables instrument and tray sets to be kept together as far as practicable in order to
ensure items remain within a particular tray/set and enable traceability through the decontamination
process, at least to tray level. Tenderers shall describe how their proposals meet this objective.
include sufficient Washer-disinfectors and ultrasonic cleaners so that throughput can be maintained
within normal operating hours when any one Washer-disinfector and/or ultrasonic cleaner arrangement
is out of service, for example when undergoing testing or maintenance.
provide details for the throughput quantity and item type for each machine on which the tender is
based.
ensure specified load handling equipment offered is compatible with the department workload content
and frequency profile.
specify the proposed solution in clause D42 for return tender information
50 Additional Information to be supplied by the Manufacturer
Prior to contract
The manufacturer shall:
state at the return tender stage, any commonly used surgical instruments that cannot be processed in the
Washer-disinfector that they are aware of.
if they are aware of any of commonly used surgical instruments that require pre-treatment, including
disassembly, specific orientation etc to achieve the required performance standard also state these at the
return tender stage.
state the conditions necessary to meet the performance requirements for each stage of the process and for
each operating cycle. For each operating cycle that can be used the following parameters shall be
described by the manufacturer:a) any restrictions on use, in particular, the type of products which the programme is designed to
clean/disinfect; this information shall be based on validation studies on specific products or product
families;
b) the accessories that shall be used;
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C30 ELEMENT 03 PAGE 29
c) the necessary chemicals needed to operate the Washer-disinfector; this shall include a choice of at
least three detergents (two of which must be from independent sources) which are compatible with the
Washer-disinfector and the loads which the Washer-disinfector is intended to process. These loads shall
include commonly used surgical instruments made of stainless steel, plated (nickel, chromium, silver)
brass or copper, coated (black, alkali soluble) steel, copper or brass, aluminium (anodised and native), and
alloys of aluminium. Some or all of these materials may be present simultaneously in any particular load.
d) the physical parameters of the processes e.g. time, temperature, amount of water, amount of chemicals,
disinfecting time/temperature.
state the chemical additives (detergents, enzyme preparations, rinse aids and other cleaning agents) and
the quality of water (pH, hardness, Total Dissolved Solids) which were used during the type testing and
product compatibility validation studies.
where final rinse water quality has been specified, state what means are to be provided to ensure that the
chemical and microbial quality of the final rinse water is maintained at a level which will not impair the
standard of cleanliness or freedom from microbial contamination achieved by the process prior to rinsing.
state any chemical or classes of chemical which are deemed unsuitable (contra-indicated) for use in the
machine.
End of Element
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C30 ELEMENT 04 PAGE 1
TEST METHODS
04
Note:
The tests described within this element are only those deemed adequate to establish the particular
requirements of element 02 clause 7.0. They do not constitute the full range of tests required for
installation, operational or performance qualification of a new Washer-disinfector. BS EN ISO 15883
and the advice of an Authorised Person (Sterilizers)[Authorising Engineer (Decontamination)] should
be consulted in order to establish the extent of testing required.
01 General
Testing shall be carried out in accordance with BS EN ISO 15883 Part 1 & 2 Annex A using specified
test loads, except as modified within this specification.
From the time when testing commences on site all test runs, whether successful or not, shall be recorded
and documented.
The cycle data from the controller (where practicable) and from the process recorder shall be retained as
part of the record of each cycle.
The test report shall include a summary sheet identifying all test cycles run.
The results of all cleaning tests shall be demonstrated within the report. This may require adequate
photography of items prior and post cleaning.
The instruments used to test the Washer-disinfector and those used to calibrate the test instruments shall
be calibrated to the standards required in BS EN ISO 15883 ¶.
02 Load Cleanliness
The cleaning efficacy of the Washer-disinfector shall be tested by determining its ability to remove a
standard test soil from either a standard test load or a typical load of the type to be processed in the unit.
The test soil to be used will conform to the specification given in BS EN ISO 15883-5 for each of the load
types to be processed but will be comparable with that used by the S.S.D. Department.
When the Washer-disinfector is to be used to process anaesthetic accessories as well as surgical
instruments and hollowware this will require two different test soils and three sets of three challenge
loads to be successfully processed
Satisfactory soil removal will be determined by visual inspection and, at the discretion of the purchaser,
by determination of the absence of residual protein using a qualitative method as defined in BS EN ISO
15883 Part 1 Annex C
Cleaning shall be regarded as satisfactory when not less than three challenge loads for each type of goods
to be processed have been satisfactorily cleaned.
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C30 ELEMENT 04 PAGE 2
After establishing the cleaning efficacy as described above the performance of the machine shall be
evaluated by visual inspection of not less than 5 actual loads of each type to be processed. The cleaning
process shall be acceptable if less than 0.5% of not less than 200 items processed are rejected for the
presence of protein contamination or visual soiling.
03 Chamber and Carrier Cleanliness.
The efficacy of cleaning of the chamber and load carrier surfaces shall be tested using the same test soils
and acceptance criteria as were used for testing the load cleanliness.
04 Disinfection
The attainment of thermal disinfection shall be determined by the measurement of the temperature
attained on the surfaces to be disinfected. More than one time temperature relationship may be required to
be qualified.
The attainment of disinfection conditions shall be demonstrated on three consecutive cycles for each of
the load types to be processed.
05 Load Dryness
After the load has been subjected to a wash and drying programme with the minimum drying time and
temperature specified by the manufacturer the load dryness shall be assessed by one or more of the
following methods:
Visual inspection. Not more than 0.5% of processed items from a sample of not less than 200 items shall
be visibly wet nor shall they cause visible dampness when shaken over a sheet of dry white paper nor
when placed on white Cobalt chloride impregnated paper shall there be visible red spots.
Cannulated instruments shall also be tested by passing a stream of dry air through the instrument and
allowing this to impinge on a cold mirrored surface. There shall be no misting of the mirror.
Quantitative assessment. Instruments after processing shall be weighed and then dried to constant weight
in an oven to estimate the residual mass of water.
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C30 ELEMENT 04 PAGE 3
06 Microprocessor Controller – Acceptance Test Procedure
Shall:in addition to tests described for the general commissioning of the Washer-disinfector be subjected to
the following tests by the manufacturer and demonstrated to the satisfaction of the clients
representative:(a) During an automatic cycle it is not possible to change to another automatic cycle and the safety
features of the cycle first selected cannot be circumvented.
(b) after power failure there is no memory loss of programme or entered variables.
(c) On power failure safety features of the cycle cannot be circumvented
(d) Power supply restoration, check upon the performance as detailed above.
(e) Battery "change" condition.
(f) Means to easily change battery without loss of programme.
(g) I/0 status and indication.
(h) Forcing changes in I/0 status.
(j) Operation of safety systems.
(k) Sensor failure checks.
(l) Process cycle.
(m) Instrument calibration.
(n) Printer self check print.
Note:
The tests described within element 04 of this document are only those deemed adequate to
establish the particular requirements of Element 01 clause 7.0 above. They do not constitute the
full range of tests required for installation, operational or performance qualification of a new
Washer-disinfector. BS EN ISO 15883 and the advice of an Authorising Engineer
(Decontamination) should be consulted in order to establish the extent of testing required.
End of Element
Updated by:
R.A. Jobbins
AE(D)
On behalf of:
Brighton & Sussex University Hospitals NHS Trust
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
20/08/2014
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