Packaging for terminally sterilized medical devices - Part 2: validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management
Edition 2023-10-25

Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems - Amendment 1 : application of risk management
Edition 2023-10-25

Packaging materials for terminally sterilized medical devices - Part 3 : paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods.

Systems for evacuation of plume generated by medical devices
Edition 2024-03

Biological evaluation of medical devices - Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2014-12-05

Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

Sterilization of health care products - Moist heat - Development, validation and routine control of a sterilization process for medical devices.

Packaging for terminally sterilized medical devices - Part 3: paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Edition 2017-04-08

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
Edition 2006-11-01

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Edition 2017-09