Annex to the accreditation certificate D-PL according to DIN EN ISO/IEC 17025: and council directives 90/385/EWG 2 and 93/42/EWG 3

Transcription

1 Deutsche Akkreditierungsstelle GmbH Annex to the accreditation certificate D-PL according to DIN EN ISO/IEC 17025: and council directives 90/385/EWG 2 and 93/42/EWG 3 Period of validity: to date of issue: Holder of certificate: GfPS Gesellschaft für Produktionshygiene und Sterilitätssicherung mbh Talbotstrasse 21, Aachen Testing area: Types of tests/test method: Medical devices microbiological-hygienic and physical testing on medical devices including disinfectants, cleaning devices, sterilisation methods as well as sterile barrier- and packaging systems; environmental monitoring Abbreviations used: see last page This document is a translation. The definitive version is the original German annex to the accreditation certificate. 1/8

2 Scope Testing categories Device category Characteristics/ Test options Standard method of testing Microbiological hygienic testing Medical devices Sterility test DIN EN ISO Ph. Eur. 8, USP 38 <71> Total aerobic microbial count Ph. Eur. 8, USP 38 <61> Test for particular microorganisms - Enterobacteriaceae - Salmonellae - Pseudomonas aeruginosa - Staphylococcus aureus - Escherichia coli Test for adequate antimicrobial preservation Ph. Eur. 8, USP 38 <62> SOP 120 Ph. Eur. 8, USP 38 <51> Disinfectants quantitative suspension trials to determine the bactericidal, fungicidal or levurocidal effect (comparison test) of chemical disinfectants and antiseptics (basic testing - Phase 1) detection of the bactericidal, leuvrocidal, fungicidal, tuberculocidal or mycobactericidal efficacy in a quantitative suspension test DIN EN 1040 DIN EN 1275 VAH 9 SOP 134 Period of validity: to Translation - 2/8

3 Testing categories Device category Characteristics/ Test options Standard method of testing Microbiological hygienic testing Sterilisation processes Tests within the context of routine monitoring - by moist heat - by means of biological - by dry heat - by means of biological - by ethylene oxide - by means of biological DIN EN ISO SOP 109 other applicable documents: DIN EN 285 SOP 109 DIN EN ISO SOP 109 Cleaning devices - decontamination systems for mechanically decontaminable mattresses - decontamination systems for bed frames and bedside tables - decontamination systems for circulation containers Tests within the context of routine monitoring - by means of biological - by means of biological - by means of biological SOP 147 Richtlinie des BGA AK-BWA Teil 8 SOP 147 Richtlinie des BGA AK-BWA Teil 8 SOP 147 Richtlinie des BGA AK-BWA Teil 8 Period of validity: to Translation - 3/8

4 Testing categories Device category Characteristics/ Test options Standard method of testing Microbiological hygienic and physical testing Sterile barrier- and packaging systems, packaging materials Test for conformity DIN EN ISO Microbiological barrier DIN Microbiological barrier function using microbiological dusting packaging materials ASTM F 1608 packaging systems SOP 169 (ASTM F 1608) - Accelerated aging ASTM-F Dye-Test ASTM F determination of peel characteristics and seal width - determination of pinholes in plastic laminate ASTM F 3039 DIN EN DIN EN visual inspection ASTM F 1886/F 1886M Period of validity: to Translation - 4/8

5 Environmental Monitoring by Production and Testing of Product Cleanliness according to DIN EN ISO 13485: , Par. 6.4 and Par. 7.5 Microbiological Medical devices Test for bacterial endotoxins Ph. Eur. 8, hygienic testing (LAL-Test) USP 38 <85> Air-conditioning Systems Water and Aqueous Solutions Determination of a population of microorganisms on products DIN EN ISO Clean-room monitoring DIN EN ISO DIN EN ISO DIN EN ISO DIN EN ISO VDI 6022 Paper 1 VDI 2083 Paper 3 Air DIN EN ISO DIN EN ISO DIN VDI 2083 Paper 3 Surfaces DIN EN ISO DIN EN ISO Semi-quantitative microbial enumeration in compressed air Microbiological enumeration test SOP 119 SOP 120 Ph. Eur. 8, USP 38 <61> SOP 120 Regulations 5 DIN EN : DIN EN 1040 : DIN EN 1275 : Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods 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) 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) Period of validity: to Translation - 5/8

6 DIN : Ventilation and air conditioning - Part 4: Ventilation in buildings and rooms of health care DIN EN ISO : Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO : Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products DIN EN ISO : 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 : Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration DIN EN ISO : Cleanrooms and associated controlled environments - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO DIN EN ISO : Cleanrooms and associated controlled environments - Part 3: Test methods (ISO :2005) DIN EN ISO : Cleanrooms and associated controlled environments - Part 4: Design, construction and start up DIN EN ISO : Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods DIN EN ISO : Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data DIN : AK-BWA ASTM F ASTM F 1886/F1886M-09 ASTM F ASTM F Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized Working Committee for Bedframe and Trolley Decontamination: mechanical cleaning and disinfection of bedframes, bedside tables, mattresses, trollies and circulatory containers, 1997 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Period of validity: to Translation - 6/8

7 ASTM F VAH 9 : 2015 Ph. Eur. 8, Ph. Eur. 8, Ph. Eur. 8, Ph. Eur. 8, Ph. Eur. 8, Richtlinie des BGA SOP 109 SOP 119 SOP 120 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration detection of the bactericidal, leuvrocidal, fungicidal, tuberculocidal or mycobactericidal efficacy in a quantitative suspension test Test for sterility Microbiological testing of non-sterile products: Total viable aerobic count Microbiological examination of non-sterile products (test for specific micro-organisms) Test for bacterial endotoxins Efficacy of microbial preservation Guidelines from the Federal Ministry for Health for the testing of thermal disinfection processes and cleaning machinery (Complied from the comments on the guidelines of the BGA for the testing of thermal disinfection processes and cleaning machinery, ) Microbiological in process control of EO-/steam-/heat-/ plasmasterilisation Semi-quantitative determination of the microbial count in compressed air Microbiological Differentiation SOP 134 Quantitative suspension test for evaluation of bactericidal and / or fungicidal activity SOP 147 SOP 169 USP 38: 2015, <51> USP 38: 2015, <61> USP 38: 2015, <62> USP 38: 2015, <71> USP 38: 2015, <85> VDI 2083 Paper 3: VDI 6022 Paper 1: Testing of dishwashers, disinfection machine and disinfection facilities for trollies and bedframes using bio Testing of microbial barrier behaviour by microbiological dusting Antimicrobial Effectiveness Test Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms Sterility Tests Bacterial Endotoxins Test Cleanroom technology - Metrology and test methods Hygienic requirements for ventilating and air-conditioning systems and air-handling units, industrial and production sites Period of validity: to Translation - 7/8

8 Abbreviations used (not translated): AK-BWA DIN EN FDA ISO Ph. Eur. SOP USP VDI Arbeitskreis Bettgestell- und Wagendekontamination Deutsches Institut für Normung Europäische Norm Food and Drug Administration International Organization for Standardardization Pharmacopoeia European Standard Operating Procedure (Standardarbeitsanweisung der GfPS) United States Pharmacopeia Verein Deutscher Ingenieure 1 DIN EN ISO/IEC : General requirements for the competence of testing and calibration laboratories 2 Council directive 90/385/EWG des Rates vom 20. Juni 1990 zur Angleichung der Rechtsvorschriften der Mitgliedstaaten über aktive implantierbare medizinische Geräte, ABl. Nr. L 189 vom 20. Juli 1990, S. 17; zuletzt geändert durch Richtlinie 2007/47/EG vom 05. September 2007, ABl. Nr. L 247 vom 21. September 2007, S Council directive 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte, ABl. Nr. L 169 vom 12. Juli 1993, S. 1; zuletzt geändert durch Richtlinie 2007/47/EG vom 05. September 2007, ABl. Nr. L 247 vom 21. September 2007, S DIN EN ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes 5 For the transitional periods see the list of harmonized standards on the EU homepage. Period of validity: to Translation - 8/8