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Biologische Sicherheit von Medizinprodukten
Basic principles – 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 10993-12: 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 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
- 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
- CEN ISO/TS 13004: Sterilization of health care products ?Radiation ? Substantiation of selected sterilization dose: Method VDmaxSD
- 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: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of 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 5343: Cleanliness of medical devices – Process design and 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 reprocessing in health care facilities: A guide for medical device manufacturers
- ANSI AAMI ST72: Bacterial endotoxin – Test methods, routine monitoring and alternatives to batch testing
- ASTM F 1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F 1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- OECD 471: Bacterial Reverse Mutation Test
- USP [51]: Antimicrobial preservatives; Effectiveness
- USP [61]: Microbial limit tests
- USP [71]: Sterility tests
- USP [85]: Bacterial endotoxin test
- USP [87]: Biological reactivity tests in vitro
- 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
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