This document is a translation. The definitive version is...

This document is a translation. The definitive version is the original German annex to the accreditation certificate. 1/12

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.

Annex to the accreditation certificate D-PL-18715-01-00

Period of validity: 19.12.2014 to 18.12.2019 - Translation - 2/12

Date of issue: 29.06.2015

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


foodareas - Part 2: Semiquantitative swab method

DIN 10113-3

1997-07


foodareas - Part 3: Semiquantitative method with culture media

laminated taking up equipment (squeeze method)

applicable documents

DIN 1946-4

2008-12

Ventilation and air conditioning -

Part 4: Ventilation in buildings and rooms of

health care

1.2 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)




ASU L 00.00-55

2004-12

Examination of foods - Method for the enumeration of coagulase-

positive 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,


ASU L 00.00-133/2

2010-09


enumeration of Enterobacteriaceae in food - Part 2: Colony

(assumption of the same standard DIN ISO 21528-2,


ASU L 00.00-22

2006-09


enumeration of Listeria monocytogenes - Part 2: Counting

method

(assumption of the same standard DIN EN ISO 11290-2, issue

January 2005)




ASU L 00.00-32

2006-09


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,


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

Water quality - Enumeration of culturable micro-organisms -

Colony count by inoculation in a nutrient agar culture medium

2.2 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)




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


DIN 58962-3

1996-04

Medical microbiology - Diagnosis of

infections of the lower respiratory tract -

Part 3: Cultural examination for the

detection of bacteria and fungi




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)


ASU L 00.00-45

2006-12

Examination of foods - General method-

specific 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)

4.2 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


Listeria monocytogenes

SOP-DL 041.3 V04

2014-12


Listeria genus

SOP-DL 041.4 V04

2014-12


E. coli O157

SOP-DL 041.5 V04

2014-12


STEC

SOP-DL 041.6 V04

2014-12


Enterobacteriaceae including E. sakazakii

SOP-DL 041.7 V04

2014-12


Campylobacter spp.

SOP-DL 041.8 V04

2014-12


Clostridium spp.




SOP-DL 041.9 V04

2014-12


Staphylococcus spp.

SOP-DL 041.10 V04

2014-12


Saccharomyces cerevisae var. diastaticus

SOP-DL 041.11 V04

2014-12


Norovirus

SOP-DL 041.12 V04

2014-12


Spoilage bacteria

SOP-DL 041.13 V04

2014-12


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


GMO (Screening)

SOP-DL 041.13 V04

2014-12


GMO maize

SOP-DL 041.13 V04

2014-12


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)


2014-01

Microbiological examination of non-sterile products

(test for specified microorganisms)


2014-01

Biological Tests/Microbiological control of cellular products




Ph. Eur. 5.1.3 VIII

2014-01

Efficacy of antimicrobial conservation

6 Bacterial count of air and gases

SOP-DL 014 V03

2012-04

Analysis of air samplers, RODAC and standard sedimentation

plates


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

Analyte – Title of standard

Sample preparation/Testing technology

Test item

Ph. Eur.2.6.1 VIII

2014-01

Biological Tests/Sterility Drugs

Ph. Eur.2.6.12 VIII

2014-01

Microbiological examination of non-sterile

products (microbial enumeration test)

Drugs

Ph. Eur.2.6.13 VIII

2014-01

Microbiological examination of non-sterile

products (test for specified microorganisms)

Drugs

Ph. Eur.2.6.14 VIII

2014-01

Bacterial endotoxins Drugs

Ph. Eur.2.6.27 VIII

2014-01

Biological Tests/Microbiological control of cellular

products

Drugs

Ph. Eur.5.1.3 VIII

2014-01

Efficacy of antimicrobial conservation Drugs




7.1.2 Microbiological examinations for germ identification of samples from raw materials and

final products in the field drugs and active ingredients


In-house

method/Version


Sample preparation/Testing technology

Test item

SOP-DL 008 V02

2011-11

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 *


In-house

method/Version


Sample preparation/ Testing technology

Test item

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)

(no conformity assessment for medical devices)

Disinfectants

DIN EN 1275

2006-03



basic fungicidal or basic yeasticidal activity of

chemical disinfectants and antiseptics - Test

method and requirements (phase 1)


Disinfectants

DIN EN 14347

2005-08

Chemical disinfectants and antiseptics - Basic

sporicidal activity - Test method and requirements

(phase 1)


Disinfectants

DGHM

Standard Method 7

2001-09

Standard methods for the examination and

evaluation of chemical disinfection methods:

Examination of bacteriostatic and fungistatic

effectiveness of chemical disinfection procedures


Disinfectants





In-house

method/Version



Test item

DGHM

Standard Method 8

2001-09



evaluation of bactericidal and fungicidal activity in

the qualitative suspension test


Disinfectants

DGHM

Standard Method 9.1

2001-09



evaluation of bactericidal and fungicidal activity of

chemical disinfection methods in quantitative

suspension test


Disinfectants

DGHM

Standard Method 9.2

2001-09



testing the tuberculocidal and mycobactericidal

effectiveness of chemical disinfection methods in

quantitative suspension test


Disinfectants

DIN EN 1276

2010-01



bactericidal activity of chemical disinfectants and

antiseptics used in food, industrial, domestic and

institutional areas - Test method and

requirements (phase 2, step 1)

Disinfectants

DIN EN 1650

2013-08



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)

Disinfectants

DIN EN 13704

2002-05

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)

Disinfectants

DIN EN 13697

2015-06


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





In-house

method/Version



Test item

DGHM

Standard Method 14.1

2001-09



Surface Disinfectant - non-porous surfaces

(practical test)

Disinfectants

DGHM

Standard Method 14.2

2001-09



Surface Disinfectant - untreated wood (practical

test)


Disinfectants

DIN EN 1499

2013-07

Chemical disinfectants and antiseptics - Hygienic

handwash - Test method and requirements (phase

2/step 2)


Disinfectants

DGHM

Standard Method 10

2001-09



Hygienic hand washing - practical trial with test

persons


Disinfectants

DIN EN 1500

2013-07

Chemical disinfectants and antiseptics - Hygienic

handrub - Test method and requirements (phase

2/step 2)


Disinfectants

DGHM

Standard Method 11

2001-09



Hygienic hand disinfection - practical trial with test

persons


Disinfectants

DGHM

Standard Method 13

2001-09


evaluation of chemical disinfection methods: Skin

disinfection - practical trial with test persons (no

conformity assessment for medical devices)

Disinfectants

DGHM

Standard Method 16

2001-09


evaluation of chemical disinfection processes:

Chemical disinfection wash - insertion method

(practical test)


Disinfectants





In-house

method/Version



Test item

DGHM

Standard Method 17

2001-09



chemo-thermal laundry disinfection - bath

method according to DIN 11905 with disinfectant

before the first discharge of the liquor

(practical test)


Disinfectants

Abbreviations used:

ASU Official compendium of test methods acc. to German law - LFGB (§64)

DGHM German Society for Hygiene and Microbiology

DIN German Institute for Standardisation

EN European Standard

IEC International Electrotechnical Commission

ISO International Organization for Standardization

LFGB German Food and Feed Code

Ph. Eur. Pharmacopoea Europaea

SOP Standard Operating Procedure (In-house method of BioteCon Diagnostics GmbH)

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