Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Edition 2021-01

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants
Edition 2019-12

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Edition 2023-09

Packaging for terminally sterilized medical devices - Part 8: re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Edition 2018-12-19

Packaging for terminally sterilized medical devices - Part 7: adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Edition 2017-03-15

Medical devices utilizing animal tissues and their derivatives - Part 3: validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Edition 2008-03-01

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
Edition 2024-03

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific
Edition 2024-05

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2018-10

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1
Edition 2022-01