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NF S98-052-2/A1 ; NF EN ISO 11607-2/A1:2023-10-25
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
NF S98-052-1/A1 ; NF EN ISO 11607-1/A1:2023-10-25
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
PR NF S98-051-3 ; PR NF EN 868-3
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.
ISO 16571
Systems for evacuation of plume generated by medical devices
Edition
2024-03
NF S99-501-3 ; NF EN ISO 10993-3:2014-12-05
Biological evaluation of medical devices - Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition
2014-12-05
PR NF S98-103-1 ; PR NF EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.
PR NF S98-105 ; PR NF EN ISO 17665
Sterilization of health care products - Moist heat - Development, validation and routine control of a sterilization process for medical devices.
NF S98-051-3 ; NF EN 868-3:2017-04-08
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
NF S97-167 ; NF EN ISO 22610:2006-11-01
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
ISO 10993-11
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Edition
2017-09