Standards, Directives and Guidance Documents
Standards, Directives and Guidance Documents
• EN ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
• Medical Device Regulation (MDR): Regulation 2017/745/EU on medical devices, replacing MDD
• MDD: Guideline 93/42/EEC concerning medical devices, Guideline 90/385/EEC on active implantable medical devices, Guideline 2007/47/EC, guideline 98/79/EC on in vitro diagnostic medical devices
• MPDG: German Medical Device Law Implementation Act
• In Vitro Diagnostic Regulation (IVDR): Regulation 2017/746/EU on in vitro diagnostic medical devices
• EN ISO 9001: Quality management systems – Requirements
• EN ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
• EN ISO 14971: Medical devices – Application of risk management to medical devices
• EN 285: Sterilization – Steam sterilizers – Large sterilizers
• EN 1040: 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)
• EN 1275: 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)
• EN 1422: Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods
• EN ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
• EN ISO 8536-4: Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
• ISO 8573-7: Compressed air – Part 7: Test method for viable microbiological contaminant content
• OENORM EN ISO 9363-1: Optics and optical instruments – Contact lenses – Determination of cytotoxicity of contact lens material – Part 1: Agar overlay test and growth inhibition test
• EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management system
• EN ISO 10993-3: Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• EN ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
• EN ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
• EN ISO 10993-9: Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
• EN ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for skin sensitization
• EN ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
• EN ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
• EN ISO 10993-15: Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
• EN ISO 10993-17: Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
• EN ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
• EN ISO 10993-23: Biological evaluation of medical devices – Part 23: Tests for irritation
• ISO/TS 21726: Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
• EN ISO 11135: Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
• EN ISO 11137-1: Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• EN ISO 11137-2: Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
• EN ISO 13004: Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
• EN ISO 11138-1: Sterilization of health care products - Biological indicators - Part 1: General requirements
• EN ISO 11138-2: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• EN ISO 11138-3: Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• EN ISO 11138-7: Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
• EN ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
• EN ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
• EN ISO 11737-1: Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
• EN ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
• ISO 11979-5: Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility
• EN 13060: Small steam sterilizers
• ISO 14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
• ISO 14698-2: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
• EN ISO 14729: Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
• EN ISO 14730: Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date
• EN ISO 14937: 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
• EN ISO 17664-1: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
• EN ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
• EN ISO 17665-1: 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 TS 5343: Cleanliness of medical devices – Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods
• ISO 19227: Implants for surgery — Cleanliness of orthopedic implants — General requirements
• DIN 58356-1: Membrane filter elements – Part 1: Requirements and testing for bacteria challenge
• DIN 58953-6: Sterilization – Sterile supply – Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
• AAMI TIR12: Designing, testing and labeling reusable medical devices for processing by health care facilities: A guide for medical device manufacturers
• ANSI AAMI ST72: Bacterial endotoxin – Test methods, routine monitoring and alternatives to batch testing
• ANSI AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
• ASTM F1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM F3208: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3293: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3321: Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• Pharm Eur 2.6.12: Microbiological examination of non-sterile products: microbial enumeration test
• Pharm Eur 2.6.13: Microbiological examination of non-sterile products: Test for specified microorganisms
• Pharm Eur 2.6.14: Bacterial endotoxins
• Pharm Eur 2.2.44: TOC in water for pharmaceutical use
• Pharm Eur 5.1.3: Efficacy of antimicrobial preservation
• USP (51): Antimicrobial effectiveness testing
• USP (61): Microbial limit tests
• USP (71): Sterility tests
• USP (85): Bacterial endotoxin test
• USP (87): Biological reactivity tests in vitro
• USP (643): Total Organic Carbon
• USP (788): Particulate matter in injections
• USP (1116): Microbiological evaluation of clean rooms and other environments
• RDS 007: Information to be provided by the manufacturer for the processing of medical devices – selection and documentation of provision of evidence
• FDA: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff
• KRINKO/RKI/BfArM guideline: 2012, Hygienic requirements for processing of medical devices
