Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Edition 2021-11

Packaging for terminally sterilized medical devices - Part 5: sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Edition 2018-12-19

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Application of risk management (ISO 11607-1:2019/Amd 1:2023); Amendment A1
Edition 2023-11

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Application of risk management (ISO 11607-2:2019/Amd 1:2023); Amendment A1
Edition 2023-11

Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2 : Revision to 4.3.4 and 11.2
Edition 2019-11-20

Systems for evacuation of plume generated by medical devices

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
Edition 2024-06

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Edition 2014-09-17

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
Edition 2020-09

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Edition 2017-05