Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Edition 2020-01

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

Biological evaluation of medical devices - Part 4 : selection of tests for interaction with blood.

Packaging materials for terminally sterilized medical devices - Part 2 : Sterilization wrap - Requirements and test methods.

Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.

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

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

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

Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
Edition 2017-02-28

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2024-06