Deutsche Akkreditierungsstelle GmbH
Annex to the Accreditation Certificate D-PL-18715-01-00
according to DIN EN ISO/IEC 17025:2005
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
Holder of certificate:
BioteCon Diagnostics GmbH
Hermannswerder 17, 14473 Potsdam
Tests in the fields:
microbiological analyses of food, commodities, cosmetics and water;
microbiological analyses of food and feeding stuffs;
Methods for identification of microorganisms;
Methods for bacterial count of air and gases
Testing fields:
Drugs and active ingredients
Test methods:
Inhibitor tests
Abbreviations used: see last page
Within the given testing field marked with */**, the testing laboratory is permitted, without
being required to inform and obtain prior approval from DAkkS, the following:
*)
**)
the free choice of standard or equivalent testing methods.
the modification, development and refinement of testing methods.
The listed testing methods are exemplary. The testing laboratory maintains a current list of all
testing methods within the flexible scope of accreditation.
Within the scope of accreditation marked with with ***, the testing laboratory is permitted,
without being required to inform and obtain prior approval from DAkkS, to use standard testing
methods listed here with different issue dates.
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-18715-01-00
1
Microbiology of food stuffs and commodities ***
1.1
Determination of bacterial count in food and on surfaces
ASU L 00.00-88
2004-07
Microbiology of food and animal feeding stuffs - Horizontal method
for the enumeration of microorganisms - Colony-count technique
at 30 °C
(Acquisition of the same standard DIN EN ISO 4833, Issue
June 2003 Edition as a replacement for the previous official
method L 01.00-5)
ASU L 01.00-37
1991-12
Examination of foods; Determination of the number of yeasts and
molds in milk and milk products; Reference method
ASU L 42.00-2
1987-03
Examination of foods; Determination of the bacterial count in ice
cream; Pour plate method
SOP-DL 011 V04
2014-07
Hygiene monitoring/Contact plate method
DIN 10113-1
1997-07
Determination of surface colony count on fitment and utensils in
foodareas - Part 1: Quantitative swab method
DIN 10113-2
1997-07
Determination of surface colony count on fitment and utensils in
foodareas - Part 2: Semiquantitative swab method
DIN 10113-3
1997-07
Determination of surface colony count on fitment and utensils in
foodareas - Part 3: Semiquantitative method with culture media
laminated taking up equipment (squeeze method)
applicable documents
DIN 1946-4
2008-12
1.2
Ventilation and air conditioning Part 4: Ventilation in buildings and rooms of
health care
Enrichment methods, cultural microbiological analysis of food-specific germs by
biochemical confirmation
ASU L 00.00-20
2008-12
Examination of foods - Horizontal method for the detection of
Salmonella spp. in foods
(assumption of the same standard DIN EN ISO 6579,
issue October 2007 edition)
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
ASU L 00.00-55
2004-12
Examination of foods - Method for the enumeration of coagulasepositive staphylococci (Staphylococcus aureus and other species)
in food - Part 1: Method using Baird Parker agar
(Acquisition of the same standard DIN EN ISO 6888-1,
issue December 2003)
ASU L 00.00-132/2
2010-09
Examination of foods - Horizontal method for the enumeration of
β-glucuronidase-positive Escherichia coli in foods - Part 2: Colony
count with 5-bromo-4-chloro-3-indole-β-D-glucuronide
(assumption of the same standard DIN ISO 16649 -2,
Issue December 2009)
ASU L 01.00-25
1997-09
correction
2002-12
Examination of foodstuffs - Determination of Escherichia coli in
milk, milk products, butter, cheese and ice cream - Method with
liquid culture medium; correction
ASU L 01.00-3
1987-03
Examination of foods - Determination of coliforms bacteria in
milk, milk products, butter, cheese and ice cream; Method with
solid medium
ASU L 05.00-5
1990-06
Examination of foods - Determination of Enterobacteriaceae in
eggs, egg products, mayonnaise, emulsified sauces and
cold ready-made sauces - Pour plate method
(Reference method)
ASU L 00.00-133/1
2010-09
Examination of foods - Horizontal method for the detection and
enumeration of Enterobacteriaceae in food - Part 1: MPN
technique
(assumption of the same standard DIN ISO 21528-1,
issue December 2009)
ASU L 00.00-133/2
2010-09
Examination of foods - Horizontal method for the detection and
enumeration of Enterobacteriaceae in food - Part 2: Colony
(assumption of the same standard DIN ISO 21528-2,
issue December 2009)
ASU L 00.00-22
2006-09
Examination of foods - Horizontal method for the detection and
enumeration of Listeria monocytogenes - Part 2: Counting
method
(assumption of the same standard DIN EN ISO 11290-2, issue
January 2005)
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
ASU L 00.00-32
2006-09
Examination of foods - Horizontal method for the detection and
enumeration of Listeria monocytogenes - Part 1: Detection
method
(assumption of the same standard DIN EN ISO 11290-1,
issue January 2005)
ASU L 06.00-43
2011-06
Examination of foods - Enumeration of Pseudomonas spp. in
meat and meat products
(assumption of identically worded standard DIN EN ISO 13720,
issue December 2010)
ASU L 01.00-72
2011-01
Examination of foods - Determination of presumptive Bacillus
cereus in milk and milk products - Part 1: Colony count technique
at 37 ° C
(assumption of the same German standard DIN 10198,
issue July 2010)
ASU L 00.00-57
2006-12
Examination of foods - Method for the enumeration of
Clostridium perfringens in foods - Colony count method
(assumption of the same standard DIN EN ISO 7937,
issue November 2004 edition)
ASU L 06.00-39
1994-05
Examination of foods - Determination of sulfite-reducing
clostridia in mesophilic meat and meat products-ratios - pour
plate method (Reference method)
(Acquisition of homonymous German standard DIN 10103,
issue August 1993)
2
Water analysis ***
2.1
Microbiological parameters (unspecific methods of cultivation)
DIN EN ISO 6222
1999-07
2.2
Water quality - Enumeration of culturable micro-organisms Colony count by inoculation in a nutrient agar culture medium
Microbiological parameters (specific methods of cultivation)
DIN EN ISO 9308-1
2001-07
Water quality - Detection and enumeration of Escherichia coli
coliform bacteria - Part 1: Membrane filtration method
(ISO 9308-1:2000)
(withdrawn standard)
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
DIN EN ISO 7899-2
2000-11
Water quality - Detection and enumeration of intestinal
enterococci - Part 2: Membrane filtration method
(ISO 7899-2:2000)
DIN EN ISO 16266
2008-05
Water quality - Detection and enumeration of Pseudomonas
aeruginosa - Method by membrane filtration
(ISO 16266:2006)
DIN EN ISO 11731-2
2008-06
Water quality - Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low
bacterial counts
(ISO 11731-2:2004)
TrinkwV 2001
Annex 5 I e)
Detection of Clostridium perfringens by membrane filtration
SOP-DL 042 V03
2014-09
Microbiological examination of water
3
Identification of germs
SOP-DL 008 V02
2011-11
Identification of microorganisms - Bacteria, yeasts and molds by
biochemical methods, PCR and microscopy
applicable documents
DIN 58962-3
1996-04
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
Medical microbiology - Diagnosis of
infections of the lower respiratory tract Part 3: Cultural examination for the
detection of bacteria and fungi
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
4
Molecular biological analysis of food and feedings by polymerase chain reaction (PCR)
4.1
Qualitative determination of Salmonella by PCR in food ***
ASU L 00.00-52
2014-02
Examination of foods - method for the detection of Salmonella in
foods - polymerase chain reaction
(assumption of the same standard DIN 10135, issue May 2013)
applicable documents
ASU L 00.00-45
2006-12
4.2
Examination of foods - General methodspecific requirements for detection of
microorganisms using the polymerase chain
reaction (PCR) in food (assumption of the
same standard DIN EN ISO 22174,
issue May 2005)
Qualitative and quantitative determination of specific microorganisms by real time PCR
in food and feedings **
SOP-DL 041.1 V04
2014-12
Determination of microorganisms by real time PCR:
Salmonella spp.
SOP-DL 041.2 V04
2014-12
Determination of microorganisms by real time PCR:
Listeria monocytogenes
SOP-DL 041.3 V04
2014-12
Determination of microorganisms by real time PCR:
Listeria genus
SOP-DL 041.4 V04
2014-12
Determination of microorganisms by real time PCR:
E. coli O157
SOP-DL 041.5 V04
2014-12
Determination of microorganisms by real time PCR:
STEC
SOP-DL 041.6 V04
2014-12
Determination of microorganisms by real time PCR:
Enterobacteriaceae including E. sakazakii
SOP-DL 041.7 V04
2014-12
Determination of microorganisms by real time PCR:
Campylobacter spp.
SOP-DL 041.8 V04
2014-12
Determination of microorganisms by real time PCR:
Clostridium spp.
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
SOP-DL 041.9 V04
2014-12
Determination of microorganisms by real time PCR:
Staphylococcus spp.
SOP-DL 041.10 V04
2014-12
Determination of microorganisms by real time PCR:
Saccharomyces cerevisae var. diastaticus
SOP-DL 041.11 V04
2014-12
Determination of microorganisms by real time PCR:
Norovirus
SOP-DL 041.12 V04
2014-12
Determination of microorganisms by real time PCR:
Spoilage bacteria
SOP-DL 041.13 V04
2014-12
Determination of microorganisms by real time PCR:
Hygiene screening for Staphylococcus spp., Micrococcus spp.,
Corynebacterium spp.
4.3
Qualitative and quantitative determination of genetically modified organisms (GMO) by
PCR and real time PCR in food and animal feeding stuffs **
SOP-DL 041.13 V04
2014-12
Determination of microorganisms by real time PCR:
GMO (Screening)
SOP-DL 041.13 V04
2014-12
Determination of microorganisms by real time PCR:
GMO maize
SOP-DL 041.13 V04
2014-12
Determination of microorganisms by real time PCR:
GMO soy bean
5
Microbiological analysis of raw materials and final products in the field cosmetics acc. to
Pharmacopoea Europaea ***
Ph. Eur. 2.6.1 VIII
2014-01
Biological Tests/Sterility
Ph. Eur. 2.6.12 VIII
2014-01
Microbiological examination of non-sterile products
(microbial enumeration test)
Ph. Eur. 2.6.13 VIII
2014-01
Microbiological examination of non-sterile products
(test for specified microorganisms)
Ph. Eur. 2.6.27 VIII
2014-01
Biological Tests/Microbiological control of cellular products
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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Annex to the accreditation certificate D-PL-18715-01-00
Ph. Eur. 5.1.3 VIII
2014-01
6
Efficacy of antimicrobial conservation
Bacterial count of air and gases
SOP-DL 014 V03
2012-04
Analysis of air samplers, RODAC and standard sedimentation
plates
applicable documents
DIN 1946-4
2008-12
Ventilation and air conditioning Part 4: Ventilation in buildings and rooms of
health care
DIN 10113-1
1997-07
Determination of surface colony count on
fitment and utensils in foodareas Part 1: Quantitative swab method
7
Drugs and active ingredients ***
7.1
Microbiology of drugs and active ingredients
7.1.1
Microbiological analysis of raw materials and final products in the field drugs and active
ingredients acc. to Pharmacopoea Europaea
Standard/Date of issue
In-house
method/Version
Ph. Eur.2.6.1 VIII
2014-01
Ph. Eur.2.6.12 VIII
2014-01
Ph. Eur.2.6.13 VIII
2014-01
Ph. Eur.2.6.14 VIII
2014-01
Ph. Eur.2.6.27 VIII
2014-01
Ph. Eur.5.1.3 VIII
2014-01
Analyte – Title of standard
Sample preparation/Testing technology
Test item
Biological Tests/Sterility
Drugs
Microbiological examination of non-sterile
products (microbial enumeration test)
Microbiological examination of non-sterile
products (test for specified microorganisms)
Bacterial endotoxins
Drugs
Biological Tests/Microbiological control of cellular
products
Efficacy of antimicrobial conservation
Drugs
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
Drugs
Drugs
Drugs
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Annex to the accreditation certificate D-PL-18715-01-00
7.1.2
Microbiological examinations for germ identification of samples from raw materials and
final products in the field drugs and active ingredients
Standard/Date of issue
In-house
method/Version
SOP-DL 008 V02
2011-11
Analyte – Title of standard
Sample preparation/Testing technology
Test item
Identification of microorganisms
(bacteria, yeasts and molds) by
biochemical tests, PCR, microscopy
Pharmaceutical
isolates/pure
cultures
8
Health care (hygiene)
8.1
Hygienic microbiological examinations
8.1.1
Examination methods for inhibitor-tests *
Standard/Date of issue
In-house
method/Version
DIN EN 1040
2006-03
DIN EN 1275
2006-03
DIN EN 14347
2005-08
DGHM
Standard Method 7
2001-09
Analyte – Title of standard
Sample preparation/ Testing technology
Test item
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)
(no conformity assessment for medical devices)
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)
(no conformity assessment for medical devices)
Chemical disinfectants and antiseptics - Basic
sporicidal activity - Test method and requirements
(phase 1)
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods:
Examination of bacteriostatic and fungistatic
effectiveness of chemical disinfection procedures
(no conformity assessment for medical devices)
Disinfectants
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
Disinfectants
Disinfectants
Disinfectants
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Annex to the accreditation certificate D-PL-18715-01-00
Standard/Date of issue
In-house
method/Version
DGHM
Standard Method 8
2001-09
DGHM
Standard Method 9.1
2001-09
DGHM
Standard Method 9.2
2001-09
DIN EN 1276
2010-01
DIN EN 1650
2013-08
DIN EN 13704
2002-05
DIN EN 13697
2015-06
Analyte – Title of standard
Sample preparation/ Testing technology
Test item
Standard methods for the examination and
evaluation of chemical disinfection methods:
evaluation of bactericidal and fungicidal activity in
the qualitative suspension test
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods:
evaluation of bactericidal and fungicidal activity of
chemical disinfection methods in quantitative
suspension test
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods:
testing the tuberculocidal and mycobactericidal
effectiveness of chemical disinfection methods in
quantitative suspension test
(no conformity assessment for medical devices)
Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and
antiseptics used in food, industrial, domestic and
institutional areas - Test method and
requirements (phase 2, step 1)
Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical
disinfectants and antiseptics used in food,
industrial, domestic and institutional areas - Test
method and requirements (phase 2, step 1)
Chemical disinfectants - Quantitative suspension
test for the evaluation of sporicidal activity of
chemical desinfectants used in food, industrial,
domestic and institutional areas - Test method
and requirements (phase 2/step 1)
Chemical disinfectants and antiseptics Quantitative non-porous surface test for the
evaluation of bactericidal and/or fungicidal
activity of chemical disinfectants used in food,
industrial, domestic and institutional areas - Test
method and requirements without mechanical
action (phase 2, step 2)
Disinfectants
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
Disinfectants
Disinfectants
Disinfectants
Disinfectants
Disinfectants
Disinfectants
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Annex to the accreditation certificate D-PL-18715-01-00
Standard/Date of issue
In-house
method/Version
DGHM
Standard Method 14.1
2001-09
Analyte – Title of standard
Sample preparation/ Testing technology
Test item
Standard methods for the examination and
evaluation of chemical disinfection methods:
Surface Disinfectant - non-porous surfaces
(practical test)
Disinfectants
DGHM
Standard Method 14.2
2001-09
Standard methods for the examination and
evaluation of chemical disinfection methods:
Surface Disinfectant - untreated wood (practical
test)
(no conformity assessment for medical devices)
Chemical disinfectants and antiseptics - Hygienic
handwash - Test method and requirements (phase
2/step 2)
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods:
Hygienic hand washing - practical trial with test
persons
(no conformity assessment for medical devices)
Chemical disinfectants and antiseptics - Hygienic
handrub - Test method and requirements (phase
2/step 2)
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods:
Hygienic hand disinfection - practical trial with test
persons
(no conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection methods: Skin
disinfection - practical trial with test persons (no
conformity assessment for medical devices)
Standard methods for the examination and
evaluation of chemical disinfection processes:
Chemical disinfection wash - insertion method
(practical test)
(no conformity assessment for medical devices)
Disinfectants
DIN EN 1499
2013-07
DGHM
Standard Method 10
2001-09
DIN EN 1500
2013-07
DGHM
Standard Method 11
2001-09
DGHM
Standard Method 13
2001-09
DGHM
Standard Method 16
2001-09
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
Disinfectants
Disinfectants
Disinfectants
Disinfectants
Disinfectants
Disinfectants
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Annex to the accreditation certificate D-PL-18715-01-00
Standard/Date of issue
In-house
method/Version
DGHM
Standard Method 17
2001-09
Analyte – Title of standard
Sample preparation/ Testing technology
Test item
Standard methods for the examination and
evaluation of chemical disinfection methods:
chemo-thermal laundry disinfection - bath
method according to DIN 11905 with disinfectant
before the first discharge of the liquor
(practical test)
(no conformity assessment for medical devices)
Disinfectants
Abbreviations used:
ASU
DGHM
DIN
EN
IEC
ISO
LFGB
Ph. Eur.
SOP
Official compendium of test methods acc. to German law - LFGB (§64)
German Society for Hygiene and Microbiology
German Institute for Standardisation
European Standard
International Electrotechnical Commission
International Organization for Standardization
German Food and Feed Code
Pharmacopoea Europaea
Standard Operating Procedure (In-house method of BioteCon Diagnostics GmbH)
Period of validity: 19.12.2014 to 18.12.2019
Date of issue: 29.06.2015
- Translation -
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