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Medical DevicesmdsStandards, Directives and Guidance Documents

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 10993-12: 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 17664-1: 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

  • 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

  • ASTM E1837: Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)

  • 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 5.1.3: Efficacy of antimicrobial preservation

  • 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

  • KRINKO/RKI/BfArM guideline: 2012, Hygienic requirements for processing of medical devices.

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