Deutsche Akkreditierungsstelle GmbH Annex to the Accreditation Certificate D-PL-13412-01-02 according to DIN EN ISO/IEC 17025:2005 1 and the Directive 93/42/EEC 2 and 90/385/EEC 3 Indefinite since: 10.12.2018 Holder of certificate: Dr. Brill + Partner GmbH Institut für Hygiene und Mikrobiologie Stiegstück 34, 22339 Hamburg Norderoog 2, 28259 Bremen Field: Testing fields/test items: Medical devices microbiological-hygienic testing of medical devices including disinfectants, cleaning-devices, endoscopes (reprocessed), sterilization methods; environmental monitoring Abbreviations used: see last page The certificate together with its annex reflects the status at the time of the date of issue. The current status of the scope of accreditation can be found in the database of accredited bodies of Deutsche Akkreditierungsstelle GmbH. https://www.dakks.de/en/content/accredited-bodies-dakks This document is a translation. The definitive version is the original German annex to the accreditation certificate. Page 1 of 12
Testing field Test item Device(category) Type of testing Test Regulation Testing method Microbiologicalhygienic testing Medical devices Sterility test Ph. Eur. 8, 2.6.1 USP 37 <71> SOP 5.4.6 AA04 Enumeration of total viable aerobic microorganisms Detection of specific microorganisms Ph. Eur. 8, 2.6.12 USP 37 <61> SOP 5.4.6 AA09 Ph. Eur. 8, 2.6.13 USP 38 <62> SOPO 5.4.6 AA10 Microbial challenge test Ph. Eur. 8, 5.1.3 USP 38 <51> SOP 5.4.8 AA06 SOP 5.4.8 AA07 Disinfectant Testing of antimicrobial effect Efficacy testing of cleaningdevices Efficacy testing of disinfectants Quantitative suspension test for the evaluation of bactericidal, fungicidal or levurocidal or sporicidal activity of chemical disinfectants and antiseptics (basis test phase 1) ASTM E2149-10 ASTM E2180-07 ISO 22196 JIS Z 2801 SOP 5.4.9 AA09 ASTM E2314-03 ASTM E1837-96 DIN EN 1040 DIN EN 1275 DIN EN 14347 SOP 5.4.4 AA01 SOP 5.4.4 AA02 SOP 5.4.4 AA26 Indefinite since: 10.12.2018 - Translation - Page 2 of 12
Testing field Test item Device(category) Type of testing Test Regulation Testing method Microbiologicalhygienic testing Disinfectant Determination of bacteriostatic and leuvrostatic efficacy as well as suitable neutralization agents VAH 7 SOP 5.4.3 AA01 Determination of bactericidal and leuvrocidal efficacy in a qualitative suspension test VAH 8 SOP 5.4.3 AA02 Quantitative suspension test for the evaluation of bactericidal, fungicidal or mycobactericidal or sporicidal activity of chemical disinfectants in the medical area (phase 2, step 1) Determination of bactericidal, leuvrocidal, fungicidal, tuberculocidal or mycobatericidal efficacy in a quanti-tative suspension test Determination of bactericidal, leuvrocidal, fungicidal, tuberculocidal or mycobatericidal efficacy on non-porous surfaces in practical experiments - Surface disinfection without mechanics - Surface disinfection with mechanics - 4-fields test DIN EN 13727 DIN EN 13624 DIN EN 14348 SOP 5.4.4 AA23 SOP 5.4.4 AA16 SOP 5.4.4 AA27 VAH - Methode 9 SOP 5.4.3 AA03 VAH - Methode 14.1 Richtlinie BGA SOP 5.4.3 AA04 VAH - Methode 14.1 Richtlinie BGA SOP 5.4.3 AA14 Indefinite since: 10.12.2018 - Translation - Page 3 of 12
Testing field Test item Device(category) Type of testing Test Regulation Testing method Microbiologicalhygienic testing Disinfectant Quantitative germ carrier test for testing the bactericidal, fungicidal or levurocidal, mycobactericidal effect in human medicine (Phase 2, Step 2) DIN EN 14561 DIN EN 14562 DIN EN 14563 Guideline RKI SOP 5.4.4 AA30 SOP 5.4.4 AA31 SOP 5.4.4 AA32 Chemothermic laundry disinfection (phase 2, step 2) DIN EN 16616 Chemical/Chemo-Thermal Instrument Disinfection - Practical Quantitative Germ Carrier Test VAH - Methode 15 Guideline RKI SOP 5.4.3 AA06 Chemical laundry disinfection inlay procedure (practicelike test) VAH 16 SOP 5.4.3 AA07 Testing the bactericidal and yeasticidal activity of chemical disinfectants on non-porous surfaces by means of- DIN EN 16615 Richtlinie BGA - practical quantitative 4-fields test with mechanics Thermochemical laundry disinfection single bath method (practice-like test) - at temperatures from 30 C to < 60 C VAH - Methode 17.1 SOP 5.4.3 AA07 - at temperatures from 60 C to 70 C VAH-Methode 17.2 SOP 5.4.3 AA07 Indefinite since: 10.12.2018 - Translation - Page 4 of 12
Testing field Test item Device(category) Type of testing Test Regulation Testing method Microbiologicalhygienic testing Cleaning devices Examination within routine monitoring - Cleaning and disinfection devices for bedpans - Cleaning and disinfection devices for instruments - using bioindicators SOP 5.4.7 AA05 (Höller et al., D4) - using bioindicators SOP 5.4.7 AA09 SOP 5.4.7 AA10 (Höller et al., C3.3; R 4.2) - Washing machines - using bioindicators SOP 5.4.7 AA04 (Höller et al., D 2.2) Endoscopes (reprocessed) Sterilization method - with moist heat - with dry heat Control of endoscope reprocessing Examination within routine monitoring - using bioindicators Höller et al., E 6.1 SOP 5.4.7 AA11 Recommendation DGKH SOP 5.4.7 AA03 Also applicable: DIN EN ISO 11138-3 DIN EN ISO 11138-4 Environmental monitoring in production and testing of cleanliness of products according to DIN EN ISO 13485 : 2012 4 / DIN EN ISO 13485 : 2016 5, 6.4 and 7.5 Microbiologicalhygienic testing Medical devices Estimation of population of microorganisms on products (determination of bioburden) DIN EN ISO 11737-1 SOP 5.4.6 AA 08 Indefinite since: 10.12.2018 - Translation - Page 5 of 12
Standort Norderoog 2, 28259 Bremen Testing field Test item Device(category) Type of testing Test Regulation Testing method Microbiologicalhygienic testing Medical devices Standard Test Method for Determination of Virucidal Efficacy on the Surface of Medical Examination Gloves based on ASTM D7907-14 SOP 5.4.2 AA19 (ASTM D7907-14) Measurement of antiviral activity on plastics and other non-porous surfaces based on JIS Z 2801/ISO 22196 SOP 5.4.2 AA20 (JIS Z 2801) (ISO 22196) Disinfectant Quantitative suspension test to determine the virucidal effectiveness of chemical disinfectants (Phase 2, Stage 1) DIN EN 14476 Leitlinie DVV/RKI ASTM E1052-11 SOP 5.4.2 AA03 Testing the virucidal effectiveness of chemical disinfectants with practical test models (Phase 2, Level 2) Leitlinie DVV SOP 5.4.2 AA05 SOP 5.4.2 AA06 SOP 5.4.2 AA07 SOP 5.4.2 AA08 SOP 5.4.2 AA12 Carrier test for testing instrument disinfectants on frosted glass (Phase 2/Stage 2) SOP 5.4.2 AA14 Also applicable: DIN EN 14561 Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate Nonporous Environmental Surfaces ASTM E1053-11 SOP 5.4.2 AA16 Indefinite since: 10.12.2018 - Translation - Page 6 of 12
Regulations 6 DIN EN 1040 : 2006-03 DIN EN 1275 : 2006-03 DIN EN ISO 11138-3 : 2009-09 DIN EN ISO 11138-4 : 2006-09 DIN EN ISO 11737-1 : 2009-09 DIN EN 13624 : 2013-12 DIN EN 13727 : 2015-12 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) 1 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); Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in medical area - Test method and requirements (phase 2, step 1) DIN EN 14347 : 2005-08 Chemical disinfectants and antiseptics-basic sporicidal activity - Test method and requirements (phase 1) DIN EN 14348 : 2005-04 DIN EN 14476 : 2015-12 DIN EN 14561 : 2006-08 DIN EN 14562 : 2006-08 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1) Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) Indefinite since: 10.12.2018 - Translation - Page 7 of 12
DIN EN 14563 : 2009-02 DIN EN 16615 : 2015-06 DIN EN 16616 : 2015-10 ISO 22196:2011-08 ASTM E1052-11 ASTM E1053-11 ASTM E1837-96 ASTM E2149-10 ASTM E2180-07 ASTM E2314-03 Recommendation DGKH JIS Z 2801:2006 Guideline DVV Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection test method and requirements (phase 2, step 2) Measurement of antibacterial activity on plastics and other nonporous surfaces Standard Test Method to Assess the Activity of Microbiocides against Viruses in Suspension Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate Non-Porous Environmental Surfaces Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) Standard Test Method to Determining the Antimicrobial Activity of Immobilized Antimicrobial Agent(s) Under Dynamic Contact Conditions Standard Test Method to Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Stimulated Use Test) Deutsche Gesellschaft für Krankenhaushygiene (DGKH), Hyg Med, 35 [3] 2010 Antimicrobial products Test for antimicrobial activity and efficacy Guideline of Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) e.v. Quantitative test of virucidal activity of chemical disinfectants on non-porous surfaces (application i the medical area) (phase 2, step 2), Hyg & Med, 37 3, 78-85 Indefinite since: 10.12.2018 - Translation - Page 8 of 12
Guideline DVV/RKI Guideline BGA Guideline RKI Ph. Eur. 8, 2.6.1 Ph. Eur. 8, 2.6.12 Ph. Eur. 8, 2.6.13 Ph. Eur. 8, 5.1.3 USP 38 <51> USP 38 <61> USP 38 <62> USP 38 <71> VAH 7 : 2015 VAH 8 : 2015 VAH 9 : 2015 VAH 14 : 2015 VAH 15 : 2015 VAH 16 : 2015 VAH 17 : 2015 SOP 5.4.2 AA03 Guideline of Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) e.v. and Robert Koch-Institute (RKI) for testing chemical disinfectants on efficacy of viruses in the medical area, Bundesgesundheitsblatt 58 (2015) 493-504 Guideline of the Federal Health Office for testing the efficacy of surface disinfectants for the disinfection of tuberculosis, Bundesgesundheitsblatt 37 (1994): 274-278 Guideline of the Robert Koch-Institute (RKI) for testing the efficacy of disinfectants for chemical instrument disinfection at tuberculosis, Bundesgesundheitsblatt 37 (1994) 474-477 Sterility testing Microbiological testing of non-sterile products: Total viable count Microbiological testing of non-sterile products: Detection of specific microorganisms Testing on sufficient preservation Antimicrobial Effectiveness Testing Microbial Enumeration Tests Test for Specified Microorganisms Sterility Tests Determination of bacteriostatic and leuvrostatic efficacy as well as suitable neutralizing agents Determination of bactericidal and levurocidal activity in the qualitative suspension test Determination of bactericidal, levurocidal, fungicidal, tuberculocidal and mycobactericidal respectively activity in the quantitative suspension test Surface disinfection practice-like test Chemical / chemo-thermal instrument disinfection practicelike quantitative carrier test Chemical laundry disinfection inlay procedure (practice-like test) Thermochemical laundry disinfection single bath method (practice-like test) Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants in the veterinary area according to DIN EN 14675 : 2015 (phase 2, step 1) Indefinite since: 10.12.2018 - Translation - Page 9 of 12
SOP 5.4.2 AA05 SOP 5.4.2 AA06 SOP 5.4.2 AA07 SOP 5.4.2 AA08 SOP 5.4.2 AA12 SOP 5.4.2 AA14 Quantitative virucidal efficacy testing of chemical disinfectants on non-porous surfaces (pren 16777) Quantitative virucidal efficacy testing of chemical disinfectants on non-porous surfaces (carrier test according to OECD draft 2010) Quantitative virucidal efficacy testing of chemical disinfectants on treated materials Efficacy testing of chemical disinfectants on inanimate germ carriers according to ASTM E 2197-11 (phase 2, step 2) Virucidal testing of chemical disinfectants with mechanical action in the 4-field-test (phase 2, step 2) Carrier test for testing instrument disinfectants with frosted glass (phase 2, step 2) SOP 5.4.2 AA15 Testing of disinfectants according to ASTM E 1052 SOP 5.4.2 AA16 SOP 5.4.2 AA19 SOP 5.4.2 AA20 Virucidal Activity Testing on Inanimate Nonporous Surfaces according to ASTM E1053 Determination of Virucidal Efficacy on the Surface of Medical Examination Gloves based on ASTM D7907-14 Measurement of antiviral activity on non-porous surfaces based on JIS Z 2801/ISO 22196 SOP 5.4.3 AA01 Determination of MIC and suitable neutralizer, VAH 2015 (method 7) SOP 5.4.3 AA02 Qualitative suspension test VAH 2015 (method 8) SOP 5.4.3 AA03 SOP 5.4.3 AA04 Quantitative suspension test with bacteria and fungi according to VAH 2015 (method 9) Surface disinfection non-porous surfaces without mechanical action (practice-like test) VAH 2015 (method 14.1) SOP 5.4.3 AA06 Quantitative carrier test instruments (frosted glass) VAH 2015 (method 15) SOP 5.4.3 AA07 Thermochemical laundry disinfection (inlay procedure) VAH 2015 (method 17) SOP 5.4.3 AA14 Surface disinfection with mechanical action (practice-like 4- field-test) VAH 2015 (method 14.2) SOP 5.4.4 AA01 SOP 5.4.4 AA02 Quantitative suspension test for bactericidal activity according to DIN EN 1040:2005 Quantitative suspension test for fungicidal activity according to DIN EN 1275:2005 Indefinite since: 10.12.2018 - Translation - Page 10 of 12
SOP 5.4.4 AA16 SOP 5.4.4 AA23 Quantitative suspension test for fungicidal activity according to DIN EN 13624:2013 Quantitative suspension test for bactericidal activity according to DIN EN 13727:2012 SOP 5.4.4 AA26 Basic sporicidal activity according to DIN EN 14347:2005 SOP 5.4.4 AA27 SOP 5.4.4 AA30 SOP 5.4.4 AA31 SOP 5.4.4 AA32 SOP 5.4.6 AA04 SOP 5.4.6 AA08 SOP 5.4.6 AA09 SOP 5.4.6 AA10 SOP 5.4.7 AA03 SOP 5.4.7 AA04 SOP 5.4.7 AA05 SOP 5.4.7 AA09 SOP 5.4.7 AA10 SOP 5.4.7 AA11 SOP 5.4.8 AA06 SOP 5.4.8 AA07 SOP 5.4.9 AA09 Quantitative suspension test for mycobactericidal activity according to DIN EN 14348:2005 Quantitative carrier test for bactericidal activity according to DIN EN 14561:2006 Quantitative carrier test for fungicidal activity according to DIN EN 14562:2006 Quantitative carrier test for mycobactericidal activity according to DIN EN 14563:2008 Testing on sterility of medical devices and pharmaceuticals according to Ph. Eur. Determination of bioburden of instruments Enumeration of viable microorganisms according to Ph. Eur. 2.6.12 Detection of specific microorganisms according to Ph. Eur. 2.6.13 Sterility testing of medical devices and pharmaceuticals according to Ph. Eur. Examination of washing machines with bioindicators (Höller et al. 2009) Evaluation of disinfection performance of according to ISO 15883 Detection of the cleaning performance of reprocessing processes according to DIN EN ISO 15883 Detection of the disinfection performance of reprocessing processes according to DIN EN ISO 15883 Microbiological control of endoscope reprocessing Microbiological challenge test according to USP Microbiological challenge test according to Ph. Eur. Bactericidal acitivity of Wound dressings Indefinite since: 10.12.2018 - Translation - Page 11 of 12
Abbreviations DIN German Institute for Standards (Deutsches Institut für Normung) EN ISO ASTM BGA DGHM DVV European Standards (Europäische Norm) International Organization for Standardization American Society for Testing and Materials Federal Public Health Office (Bundesgesundheitsamt) Germany Society for Hygiene and Microbiology German Association for the Control of Virus Diseases (Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.v.) JIS Ph. Eur. RKI USP VAH SOP AA Japanese Standards Association European Pharmacopoeia Robert Koch Institute United States Pharmacopoeia Standard Methods of the Association for Applied Hygiene e.v. Standard operating procedures of Dr. Brill + Partner GmbH 1 DIN EN ISO/IEC 17025 : 2005-08 General requirements for the competence of testing and calibration laboratories 2 Council Directive 93 / 42 / EEC of 14 June 1993 concerning medical devices 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 4 DIN EN ISO 13485 : 2012-11 Medical devices Quality management systems. Requirements for regulatory purposes 5 DIN EN ISO 13485 : 2016-08 Medical devices Quality management systems. Requirements for regulatory purposes 6 For the transition periods, see the list of harmonized standards on the homepage of the EU. Indefinite since: 10.12.2018 - Translation - Page 12 of 12