Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Edition 2008-10

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
Edition 2009-11

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2014-10

Medical devices - Application of risk management to medical devices
Edition 2019-12

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1
Edition 2024-07

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Edition 2024-06

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1
Edition 2024-06

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2 : test methods.

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Edition 2021-06-30

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