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ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Edition
2020-01
ISO 10993-18 AMD 1
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
Edition
2022-05
PR NF S99-501-4/A1 ; PR NF EN ISO 10993-4/A1
Biological evaluation of medical devices - Part 4 : selection of tests for interaction with blood.
PR NF S98-051-2 ; PR NF EN 868-2
Packaging materials for terminally sterilized medical devices - Part 2 : Sterilization wrap - Requirements and test methods.
PR NF S99-501-12/A1 ; PR NF EN ISO 10993-12/A1
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.
NF S98-008 ; NF EN ISO 25424:2019-11-20
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Edition
2019-11-20
NF S98-008/A1 ; NF EN ISO 25424/A1:2022-05-25
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
Edition
2022-05-25
OENORM EN ISO 17665
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
Edition
2022-10-01
BS EN 868-7
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
Edition
2017-02-28
ISO/DIS 14155
Clinical investigation of medical devices for human subjects - Good clinical practice
Edition
2024-06