Basic principles – standards directives and guidance documents

Basic principles – Standards, Directives and Guidance Documents

  • EN ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
  • 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
  • MPG: German Medical Device Law
  • Medical Device Regulation (MDR): Regulation 2017/745/EU on medical devices
  • 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 materials
  • 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
  • EN ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
  • EN ISO 14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
  • EN 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 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
  • 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 34 [51]: Antimicrobial preservatives; Effectiveness
  • USP 34 [61]: Microbial limit tests
  • USP 34 [71]: Sterility tests
  • USP 34 [85]: Bacterial endotoxin test
  • USP 34 [87]: Biological reactivity tests in vitro
  • USP 34 [788]: Particulate matter in injections
  • USP 34 [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: 2015, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff