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SN EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Edition
2021-08
SN EN ISO 25424
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Edition
2020-04
SN EN ISO 14160
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 (ISO 14160:2020)
Edition
2021-08
OEVE EN 50103
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
Edition
1995-10-04
SN EN 868-9
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
Edition
2019-08
SN EN 868-10
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Edition
2019-08
SN EN ISO 10993-11
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Edition
2018-10
SN EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Edition
2020-07
SN EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Edition
2023-02
SN EN ISO 14937
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
Edition
2010-03