Deutsche Akkreditierungsstelle GmbH
Annex to the Accreditation Certificate D-PL-18488-03-00
according to DIN EN ISO/IEC 17025:200520051 and
93/42/EWG2 as well as 90/385/EWG3
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
Holder of certificate:
mdt medical device testing GmbH
Grenzenstraße 13, 88416 Ochsenhausen
at the sites:
Grenzenstraße 3, 88416 Ochsenhausen
Grenzenstraße 12, 88416 Ochsenhausen
Grenzenstraße 13, 88416 Ochsenhausen
Bahnhofstraße 11, 88416 Ochsenhausen
Beim Braunland 1, 88416 Ochsenhausen
Area:
medical devices
Area of testing:
biological, chemical, physical, physical-mechanical, microbiologicalhygienic and comparative testing of medical devices including
disinfectants, packaging systems as well as ophthalmic products
and microbiological-hygienic testing including physical testing of
sterilization procedure; environmental monitoring
This document is a translation. The definitive version is the original German annex to the accreditation certificate.
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Annex to the accreditation certificate D-PL-18488-03-00
Laboratory Site: Grenzenstraße 3, 12, 13; Bahnhofstraße 11
Area of testing
Object of examination
Product (category)
Biological, chemical Medical devices
and physical
testing
Type of Test
Description of testing
Determination of ethylene
oxide-residues after
sterilization
Medical devices,
Chemical characterization of
Sterile barrier systems materials
and packaging systems
Corpus of legislation
Test procedure
DIN EN ISO 10993-7
DIN EN ISO 10993-18
Polymers analytics
-
EGDMA-content in
2-HEMA
SOP PM 032
-
MA-content in HEMA
SOP PM 041
-
Residual MMA in
Surgiplex 121 materials
SOP PM 040
SOP PM 059
Biological, chemical Medical devices,
Chemical characterization of
and physical
Sterile barrier systems materials
testing
and packaging systems
Polymers analytics
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
DIN EN ISO 10993-18
-
Molecular weight
distribution of polymers
SOP PM 045
-
Residual MMA in PMMA
SOP PM 046
-
Residual MMA
determination of
prostheses polymers
DIN EN ISO 20795-1
-
Volatile organic
substances in PPpolymers
SOP PM 047
-
Residual monomers in
Coacryl 28 materials
SOP PM 059
-
Determination of residual SOP PM 060
monomer content of
polyacrylates
-
GC/MS-Fingerprint
- Translation
SOP PM 061
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Object of examination
Product (category)
Biological, chemical Medical devices,
and physical
Sterile barrier systems
testing
and packaging systems
Type of Test
Description of testing
-
Determination of
plasticizer
SOP PM 062
Testing of extractable
Substances
Ph. Eur. 7, 3.2.4
Physico-chemical testing of
plastics
USP 354 <661>
DIN EN ISO 11607-1
-
Conditioning of test items ASTM D 4332
-
Accelerated Aging
ASTM F 1980
-
Peel Test
ASTM F 88a
-
Determination of the seal DIN EN 868-5
strength
(Annex D)
-
Re-usable sterilization
container
DIN EN 868-8
ANSI/AAMI ST77
-
Burst-Test
ASTM F 1140
ASTM F 2054
Sterile barrier systems Tests for conformity
and packaging systems
Creep-Test
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
SOP PM 075
Testing of the microclimate
Sterile barrier systems Tests for conformity
and packaging systems
Chemical and
physical testing
Corpus of legislation
Test procedure
DIN EN ISO 11607-1
ASTM F 1140
-
Dye Test
ASTM F 1929
SOP PM 072
-
Leak testing of hollowware (penetration of
methylene blue)
SOP PM 057
-
'Bubble Emission Test'
ASTM E 515
ASTM F 2096
-
GC/MS-Fingerprint
SOP PM 061
-
Determination of the air
permeance and air
resistance (medium
range)
ISO 5636-5
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Object of examination
Product (category)
Chemische und
physikalische
Prüfungen
Blood bag systems
Physical, physicomechanical and
comparative
testing
Intraocular lenses
Type of Test
Description of testing
Tests for conformity
Corpus of legislation
Test procedure
EN ISO 3826-3
Referred documents:
EN ISO 3826-1
Contact lenses
Optical properties
DIN EN ISO 11979-2
Mechanical properties
DIN EN ISO 11979-3
Labeling
DIN EN ISO 11979-4
Shelf life
DIN EN ISO 11979-6
Measurement
DIN EN ISO 18369-3
-
Spectral transmittance
and luminous
transmittance
-
Back vertex power
measurements
-
Diameter
-
Thickness
Measurement
-
Inclusions and surface
imperfections
-
Curvature
Identification of physicochemical properties
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
-
Oxygen permeability
-
Index of refraction
-
Water content
-
Extractable substances
- Translation
DIN EN ISO 18369-3
DIN EN ISO 18369-4
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Physical, physicomechanical and
comparative
testing
Object of examination
Product (category)
Contact lenses
Type of Test
Description of testing
Corpus of legislation
Test procedure
Testing of Ageing using
UV/VIS irradiation
DIN EN ISO 11985
Determination of shelf life
DIN EN ISO 11987
Contact lenses with
lens care products
Testing of physical
compatibility
DIN EN ISO 11981
Viscoelastica
Ophthalmic implants –
Ophthalmic visco-surgical
substances
DIN EN ISO 15798
Ophthalmic implants
Tests for conformity
-
Irrigating solutions for
ophthalmic surgery
DIN EN ISO 16671
-
Ocular endotamponades
DIN EN ISO 16672
Tubes and catheters
Tests of constructive
other than
performance requirements
intravascular catheters
-
Catheter
-
Bending stability,
strength, balloon
catheter
DIN EN 1616
DIN EN 1618
DIN EN 13868
-
Gravity feed
infusion sets
-
Physico-mechanical
requirements
DIN EN ISO 8536-4
-
Breathing tubes
-
Flow resistance
Connecting pieces
leakproofness
DIN EN 12342
-
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Microbiologicalhygienic testing
Object of examination
Product (category)
Type of Test
Description of testing
Corpus of legislation
Test procedure
Environmental monitoring of the production and
testing on the hygienic conditions of the products
according DIN EN ISO 13485: 2012, § 6.4 and § 7.5
Medical devices
Testing of bacterial endotoxin Ph. Eur. 7, 2.6.14
(LAL-Test)
Testing of particulate
contamination
-
microscopic method
-
by light blockade
Ph. Eur. 7, 2.9.19
Ph. Eur. 7, 2.9.20
USP 36 <788>
USP 36 <789>
Referred document:
DIN EN ISO 45502-2-3
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
Laboratory site: Beim Braunland 1
Area of testing
Biological testing
Object of examination
Product (category)
Medical devices
Type of Test
Description of testing
Testing of cytotoxicity
Corpus of legislation
Test procedure
DIN EN ISO 10993-5
-
Test regarding changes in USP 36 <87>
cell morphology and lysis
during direct contact
(Microscopic evaluation)
-
Cell proliferation test
after contact with
extracts (colorimetric
determination of protein
synthesis)
DIN EN ISO 10993-5
-
Test regarding vitality
and lysis during direct
contact (Agar diffusion
test, Filter diffusion test)
DIN EN ISO 7405
-
Test regarding vitality
and lysis during indirect
contact (Agar diffusion
test, Filter diffusion test)
DIN EN ISO 7405
Referred documents:
DIN EN ISO 10993-1
DIN EN ISO 10993-12
Microbiologicalhygienic testing
Intraocular lenses
Biocompatibility tests
DIN EN ISO 11979-5
Medical devices
Testing of sterility
Membrane filtration
method
Direct inoculation of the
culture medium
DIN EN ISO 11737-2
Ph. Eur. 7, 2.6.1
Establishing of the
sterilization dose for
radiation sterilization
DIN EN ISO 11137-2
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
USP 36 <71>
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Area of testing
Microbiologicalhygienic testing
Object of examination
Product (category)
Type of Test
Description of testing
Sterile barrier systems Tests for conformity
and packaging systems
-
Microbiologicalhygienic testing,
including physical
testing
Microbial barrier testing
at moisture
Information for the
Testing in the context of
preparation of medical validation
devices
Corpus of legislation
Test procedure
DIN EN ISO 11607-1
DIN 58953-6
DIN EN ISO 17664
Cleaning
SOP BM 024
Disinfection
SOP BM 025
Sterilization
SOP BM 006
-
with moist heat
Referred documents:
ASTM E 2314
ASTM E 1837
AAMI TIR12
Class II Special Controls
Guidance Document
DIN EN ISO 14937
DIN EN ISO 17665-1
Microbiologicalhygienic testing
Sterilization methods
-
with moist heat
Sterilization methods
-
with ethylene
oxide
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
Testing in the context of
routine monitoring
-
DIN EN ISO 17665-1
Referred documents:
DIN EN ISO 11138-1
DIN EN 285
by using bioindicators
Testing in the scope of
validation / installation /
working / performancequalification
by using bioindicators
- Translation
DIN EN ISO 11135-1
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Microbiologicalhygienic tests
Object of examination
Product (category)
Disinfectants
Type of Test
Description of testing
Corpus of legislation
Test procedure
Quantitative suspension test DIN EN 1275
for the evaluation of basic
fungicidal or basic yeasticidal
activity of chemical
disinfectants and antiseptics
Quantitative suspension test
for the evaluation of basic
bactericidal activity of
chemical disinfectants and
antiseptics
DIN EN 1040
Quantitative suspension test
for the evaluation of
bactericidal activity of
chemical disinfectants for
instruments used in the
medical area
DIN EN 13727
Testing of virucidal efficiency DIN EN 14476
chemical disinfection process R-DVV/RKI
in vitro
-
Validation of Virus
depletion
DIN EN ISO 22442-1
DIN EN ISO 22442-2
(CPMP/BWP/268/95)
Preserved solutions
Preservative efficacy testing
(PET)
Ph. Eur. 7, 5.1.3
USP 36 <51>
Contact lenses care
products
PET for contact lens care
products
DIN EN ISO 14730
Testing of lens disinfection
and hygiene management
DIN EN ISO 14729
PET and in-use stability of
contact lens care products
DIN EN ISO 13212
DIN EN ISO 14730
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
Area of testing
Microbiologicalhygienic testing
Object of examination
Product (category)
Medical devices,
Surfaces
Type of Test
Description of testing
Corpus of legislation
Test procedure
Testing of antibacterial
efficiency and activity
-
qualitative
SOP BM 030
SOP BM 031
SOP BM 032
(ASTM E 2149)
(JIS Z 2801)
Environmental monitoring of the production and
testing on the hygienic conditions of the products
according DIN EN ISO 13485: 2012, § 6.4 und § 7.5
Medical devices
Estimation of the population
of micro-organisms of
products (Determination of
Bioburden)
-
Membrane filtration
method
-
Pour plating
-
Counting with dilution
steps (MPN-method)
-
Spread plates
Clean room technology Biocontamination control of
clean rooms and associated
controlled environments
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
DIN EN ISO 11737-1
Ph. Eur. 7, 2.6.12
Ph. Eur. 7, 2.6.13
USP 36 <61>
SOP BM 026
Referred documents:
DIN EN ISO 14698-1
DIN EN ISO 14698-2
Supplement guidance on
sterile products
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Annex to the accreditation certificate D-PL-18488-03-00
Corpus of legislation4
DIN EN 868-5 : 2009-09
Packaging for terminally sterilized medical devices - Part 5:
Sealable pouches and reels of porous materials and plastic film
construction - Requirements and test methods
DIN EN 868-8 : 2009-09
Packaging for terminally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers conforming to
EN 285 - Requirements and test methods
DIN EN 1040 : 2006-03
Chemical disinfectants and antiseptics – Quantitative suspension
test for the evaluation of basic bactericidal activity of chemical
disinfectants and antiseptics – Test method and requirements
(phase 1)
DIN EN 1275 : 2006-03
Chemical disinfectants and antiseptics – Quantitative suspension
test for the evaluation of basic fungicidal or basic yeasticidal
activity of chemical disinfectants and antiseptics – Test method
and requirements (phase 1)
DIN EN 1616 : 1999-05
Sterile urethral catheters for single use
DIN EN 1618 : 1997-04
Catheters other than intravascular catheters – Test methods for
common properties
DIN EN ISO 3826-1 : 2004-04
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers
DIN EN ISO 3826-3 : 2008-03
Plastics collapsible containers for human blood and blood
components - Part 3: Blood bag systems with integrated features
ISO 5636-5 : 2003-06
Paper and board – Determination of air permeance and air
resistance (medium range) – Part 5: Gurley method
DIN EN ISO 7405 : 2009-06
Dentistry: Evaluation of biocompatibility of medical of medical
devices used in dentistry
DIN EN ISO 8536-4 : 2011-01
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed
DIN EN ISO 10993-1 : 2010-04
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management system
DIN EN ISO 10993-5 : 2009-10
Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity
DIN EN ISO 10993-7 : 2009-02
Biological evaluation of medical devices – Part 7: Ethylene oxide
sterilization residuals
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
DIN EN ISO 10993-12 : 2012-10
Biological evaluation of medical devices – Part 12: Sample
preparation and reference materials
DIN EN ISO 10993-18 : 2009-08
Biological evaluation of medical devices - Part 18: Chemical
characterization of materials
DIN EN ISO 11135-1 : 2007-08
Sterilization of health care products – Ethylene oxide – Part 1:
Requirements for the development, validation and routine control
of a sterilization process for medical devices
DIN EN ISO 11137-2 : 2012-07
Sterilization of health care products – Radiation – Part 2:
Establishing the sterilization dose
DIN EN ISO 11138-1 : 2006-09
Sterilization of health care products – Biological indicators – Part
1: General requirements
DIN EN ISO 11607-1: 2009-09
Packaging for terminally sterilized medical devices – Part 1:
Requirements for materials, sterile barrier systems and packaging
systems
DIN EN ISO 11737-1 : 2009-09
Sterilization of medical devices – Microbiological methods – Part
1: Determination of a population of microorganisms on products
DIN EN ISO 11737-2 : 2010-04
Sterilization of medical devices - Microbiological methods - Part 2:
Tests of sterility performed in the definition, validation and
maintenance of a sterilization process
DIN EN ISO 11979-2 : 2000-07
Ophthalmic implants – Intraocular lenses – Part 2: Optical
properties and test methods
DIN EN ISO 11979-3 : 2006-07
Ophthalmic implants – Intraocular lenses – Part 3: Mechanical
properties and test methods
DIN EN ISO 11979-4 : 2013-01
Ophthalmic implants – Intraocular lenses – Part 4: Labeling and
information
DIN EN ISO 11979-5 : 2010-11
Ophthalmic implants
Biocompatibility
DIN EN ISO 11979-6 : 2007-11
Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and
transport stability
DIN EN ISO 11981 : 2009-12
Ophthalmic optics – Contact lenses and contact lens care products
– Determination of the physical compatibility of contact care
products lenses with contact lenses
DIN EN ISO 11985 : 1998-02
Ophthalmic optics – Contact lenses – Ageing by exposure to UV
and visible radiation (in vitro method)
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
–
Intraocular
lenses
–
Part
12/19
5:
Annex to the accreditation certificate D-PL-18488-03-00
DIN EN ISO 11987 : 2012-11
Ophthalmic optics – Contact lenses – Determination of shelf-life
DIN EN 12342 : 2010-01
Breathing tubes intended for use with anaesthetic apparatus and
ventilators
DIN EN ISO 13212 : 2011-08
Ophthalmic optics – Contact lens care products –Guidelines for
determination of shelf-life
DIN EN 13727 : 2012-07
Chemical disinfectants and antiseptics – Quantitative suspension
test for the evaluation of bactericidal activity of chemical
disinfectants for instruments used in the medical area – Test
method and requirements (phase 2, step 1)
DIN EN 13868 : 2002-11
Catheters – Test methods for kinking of single lumen catheters
and medical tubing
DIN EN 14476 : 2007-02
Chemical disinfectants and antiseptics - Virucidal quantitative
suspension test for chemical disinfectants and antiseptics used in
human medicine - Test method and requirements (phase 2, step
1)
DIN EN ISO 14729: 2011-01
Ophthalmic optics – Contact lens care products – Microbiological
requirements and test methods for products and regimens for
hygienic management of contact lenses
DIN EN ISO 14698-1 : 2004-04
Cleanrooms and associated controlled environments –
Biocontamination control – Part 1: General principles and
methods
DIN EN ISO 14698-2 : 2004-02
Cleanrooms and associated controlled environments –
Biocontamination control – Part 2: Evaluation and interpretation
of biocontamination data
DIN EN ISO 14730 : 2001-08
Ophthalmic optics – Contact lens care products – Antimicrobial
preservative efficacy testing and guidance on determining discard
date
DIN EN ISO 14937 : 2010-03
Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for medical
devices
DIN EN ISO 15798 : 2010-06
Ophthalmic implants – Ophthalmic viscosurgical devices
DIN EN ISO 16671: 2004-07
Ophthalmic implants – Irrigating solutions for ophthalmic surgery
DIN EN ISO 16672 : 2003-06
Ophthalmic implants – Ocular endotamponades
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
DIN EN ISO 17664 : 2004-07
Sterilization of medical devices – Information to be provided by
the manufacturer for the processing of resterilizable medical
devices
DIN EN ISO 17665-1 : 2006-11
Sterilization of health care products – Moist heat – Part 1:
Requirements for the development, validation and routine control
of a sterilization process for medical devices
DIN EN ISO 18369-3 : 2006-11
Ophthalmic optics – Contact lenses – Part 3: Measurement
methods
DIN EN ISO 18369-4 : 2006-11
Ophthalmic optics – Contact lenses – Part 4: Physicochemical
properties of contact lens materials
DIN EN ISO 20795-1 : 2009-02
Dentistry – Base polymers – Part 1: Denture base polymers
DIN EN ISO 22442-1 : 2008-03
Medical devices utilizing animal tissues and their derivatives – Part
1: Application of risk management
DIN EN ISO 22442-2 : 2008-03
Medical devices utilizing animal tissues and their derivatives – Part
2: Controls on sourcing, collection and handling
DIN EN 45502-2-3 : 2010-07
Active implantable medical devices - Part 2-3: Particular
requirements for cochlear and auditory brainstem implant
systems
DIN 58953-6 : 2010-05
Sterilization - Sterile supply - Part 6: Microbial barrier testing of
packaging materials for medical devices which are to be sterilized
ASTM D 4332-01
Standard Practice for Conditioning Containers, Packages, or
Packaging Components for Testing
ASTM E 515-11
Standard Practice for Leaks Using Bubble Emission Techniques
ASTM E 1837-96
Standard Test Method to Determine Efficacy of Disinfection
Processes for Reusable Medical Devices (Simulated Use Test)
ASTM E 2149-10
Standard Test Method for Determining the Antimicrobial Activity
of Immobilized Antimicrobial Agents Under Dynamic Contact
Conditions
ASTM E 2314-03
Test Method for Determination of Effectiveness of Cleaning
Processes for Reusable Medical Instruments Using a Microbiologic
Method Simulated Use Test
ASTM F 88/F 88M-09
Standard Test Method for Seal Strength of Flexible Barrier
Materials
ASTM F 1140 - 07
Standard Test Methods for Internal Pressurization Failure
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
Resistance of Unrestrained Packages
ASTM F 1929 - 98
Standard Test Method for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration
ASTM F 1980 - 07
Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices
ASTM F 2054-07
Standard Test Method for Burst Testing of Flexible Package Seals
Using Internal Air Pressurization Within Restraining Plates
ASTM F 2096-04
Standard Test Method for Detecting Gross Leaks in Medical
Packaging by Internal Pressurization (Bubble Test)
AAMI TIR12 : 2010
Designing, testing and labelling reusable medical devices for
reprocessing in health care facilities: A guide for medical device
manufacturers
ANSI/AAMI ST77 : 2006
Containment devices for reusable medical device sterilization
Class II Special Controls Guidance Medical Washers and Medical Washer-Disinfectors; Guidance for
Document
the Medical Device Industry and FDA Review Staff
DVV-RKI Guidance : 2008-08
Guidance document of the German Association Against Viral
Diseases (DVV) e.V. and the Robert Koch Institute (RKI), regarding
testing of chemical disinfectants on effectiveness against viruses
in humane medicine: Bundesgesundheitsbl. Jahrgang 51 Heft 8
August
2008,
S. 937-945
CPMP/BWP/268/95 : 1996-02
Note for guidance on virus validation studies: The design,
contribution and interpretation of studies validating the
inactivation and removal of viruses
Supplement guidance on sterile Supplemental and revised guideline for the production of sterile
products (IV/2244/87, rev. Sept. pharmaceutical products (September 1996) Document of the
1996)
Commission of European Communities (IV/2244/87, rev.) dated 9.
September 1996)
JIS Z 2801 : 2010-12
Antibacterial products – Test for antibacterial activity and efficacy
NF T 72-180 : 1989-12
Antiseptiques et désinfectants utilisés à l’état liquide, miscibles à
l’eau Détermination de l’activité virucide vis-à-vis des virus de
vertébrés
–
Use of liquid antiseptics and liquid disinfectants, miscible with
water; determination of virucidal activity; viruses of vertebrates
Ph. Eur. 7, 2.6.1 : 2011-04
Sterility
Ph. Eur. 7, 2.6.12 : 2010-07
Microbiological examination of non-sterile products: microbial
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
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Annex to the accreditation certificate D-PL-18488-03-00
enumeration tests
Ph. Eur. 7, 2.6.13 : 2010-04
Microbiological examination of non-sterile products: test for
specified micro-organisms
Ph. Eur. 7, 2.6.14 : 2010-01
Bacterial endotoxins
Ph. Eur. 7, 2.9.19 : 2011-04
Particulate contamination: sub-visible particles
Ph. Eur. 7, 2.9.20 : 2008-01
Particulate contamination: visible particles
Ph. Eur. 7, 3.2.4 : 2008-01
Empty sterile containers of plasticised poly(vinyl chloride) for
human blood and blood components
Ph. Eur. 7, 5.1.3 : 2011-01
Efficacy of antimicrobial preservation
SOP BM 006
Microbiological test method in the scope of development /
validation of sterilization process for medical devices according to
DIN EN ISO 14937
SOP BM 024
Procedure for reprocessing of reusable medical devices according
to DIN EN ISO 17664: Validation of cleaning processes
SOP BM 025
Procedure for reprocessing of reusable medical devices according
to DIN EN ISO 17664: evaluation of cleaning processes
SOP BM 026
Biocontamination control of cleanrooms and associated controlled
environments according to DIN EN ISO 14698
SOP BM 030
Total protein determination, BCA-micro-method
SOP BM 031
Determination of antimicrobial activity and efficacy based on JIS Z
2801
SOP BM 032
Determination the antimicrobial activity
antimicrobial agents based on ASTM E 2149
SOP PM 032
Method of determination of Ethylene glycol dimethacrylate
(EGDMA) in 2-hydroxyethyl methacrylate (2-HEMA)
SOP PM 040
Method of determination of residual methyl methacrylate content
(MMA) of Surgiplex 121
SOP PM 041
Method of determination of methacrylic acid (MA) in 2hydroxyethyl methacrylate (2-HEMA)
SOP PM 045
Method of determination of the molecular weight distribution of
polymethylmethacrylate (PMMA)
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
of
immobilized
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Annex to the accreditation certificate D-PL-18488-03-00
SOP PM 046
Method of determination of methyl methacrylate (MMA)
residuals in polymethylmethacrylate (PMMA) materials by steam
area gas-chromatography
SOP PM 047
Semi quantitative determination of volatile organic substances in
polypropylene (PP) materials
SOP PM 057
Leakage test of closed containers
SOP PM 059
Method for the determination of the residual monomer content
of Coacryl 28 intraocular buttons, Kombi-IOL buttons and
Surgiplex 121 blue materials
SOP PM 060
Determination of residual monomer content of polyacrylates
SOP PM 061
Recording of GC/MS fingerprints of medical devices and
packaging materials
SOP PM 062
method to test the microclimate under bandage materials
SOP PM 072
Seal strength leak test of non-porous materials
SOP PM 075
Determination of plasticizer in medical devices
USP 36 <51> : 2013
Antimicrobial preservatives; Effectiveness
USP 36 <61> : 2013
Microbial limit tests
USP 36 <71> : 2013
Sterility tests
USP 36 <87> : 2013
Biological reactivity tests; in vitro
USP 36 <788> : 2013
Particulate matter in injections
USP 36 <789> : 2013
Particulate matter in ophthalmic solutions
USP 36 <661> : 2013
Physicochemical Tests – Plastics
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
17/19
Annex to the accreditation certificate D-PL-18488-03-00
Abbreviations
AAMI
Association for the Advancement of Medical Instrumentation
ANSI
American National Standards Institute
ASTM
American Society for Testing and Materials
DGHM
German Society for Hygiene and Microbiology
DIN
German institute for standardization
EN
European standard
ISO
International Organization for Standardization
JIS
Japanese Industrial Standard
Ph. Eur.
Pharmacopeia European
SOP
Standard Operating Procedure of mdt medical device testing GmbH
USP
United States Pharmacopeia
Approved signatory
Name
Division
Mr. Klaus Altvater
Physical/chemical and mechanical/optical division
Ms. Sigrid Bail
Project management
Mr. Thorsten Bartsch
Microbiological division
Ms. Friederike Betz
Microbiological division
Ms. Magdalena Driendl
Physical/chemical and mechanical/optical division
Ms. Bernadette Eberle
Cytotoxicological division
Ms. Dr. Beate Heinz
Cytotoxicological division
Ms. Anja Hofmann
Frau Beatrix Kächele
Cytotoxic and virological division
Quality management
Ms. Beate Klumpp
All divisions
Mr. Thomas Kögel
Quality management
Mr. Dr. Ulrich Matern
All divisions
Ms. Simone Michl
Cytotoxicological division
Mr. Michael Ohnmacht
Quality management
Mr. Jan Peeters
All divisions
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
18/19
Annex to the accreditation certificate D-PL-18488-03-00
Ms. Dr. Ingrid Rapp
Cytotoxicological and virological division
Mr. Andreas Röhrig
Physical/chemical and mechanical/optical division
Ms. Carolin Steinhilber
Project management
Ms. Anita Werner
Physical/chemical division
Mr. Reinhold Wohnhas
Microbiological division
Mr. Dr. Benjamin Zeitler
Virological division
Mr. Patricio Zenglein
Physical/chemical and mechanical/optical division
1
DIN EN ISO/IEC 17025 : 2005-08 General requirements for the competence of testing- and calibration laboratories
Council Directive 93/42/EEC of 14. June 1993 concerning medical devices. Official journal of the European Communities No. L169/1 from
12.7.93; last modified through Council Directive 2001/104/EC of 7. December 2001, ABI. No. L 6/50 of 10.1.2002
3 Council Directive 90/385/EEC of 20. June 1990 on the approximation of the laws of the Member States relating to active implantable
medical devices. Official journal of the European Communities No. L 189/17 of 20.7.1990; modified through Directive 93/42/EEC, ABI. No. L
169/1 of 12.7.1993 and through Directive 93/68/EEC, ABI No. L 220/1 of 30.8.1993
4
Regarding the transition periods see the list of harmonized standards on the homepage of the EU
2
Period of validity: 09.12.2013 to 05.06.2018
Date of issue: 09.12.2013
- Translation
19/19