Packaging for terminally sterilized medical devices. 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 2017-02-28

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 2007-01-31

Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
Edition 2010-01

Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Edition 2021-06-16

Packaging for terminally sterilized medical devices - Part 6: paper for low temperature sterilization processes - Requirements and test methods
Edition 2017-04-01

Packaging for terminally sterilized medical devices - Part 4: paper bags - Requirements and test methods
Edition 2017-04-01

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Edition 2017-12-06

Medical devices utilizing animal tissues and their derivatives - Part 2: controls on sourcing, collection and handling
Edition 2020-12-09

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Edition 2019-11

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Edition 2019-12