Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
Edition 2023-05-30

Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
Edition 2021-06-30

Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
Edition 2023-05-30

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2018-01-16

Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution
Edition 2015-10-15

Single-use medical examination gloves Part 1: Specification for gloves made from rubber látex solution
Edition 2015-10-15

Gas mixers for medical use - Stand-alone gas mixers
Edition 2021-04-29

Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
Edition 2024-02-22

Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
Edition 2024-02-29

Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
Edition 2021-01-12