In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2: validation and verification
Edition 2022-07-22

Medical devices utilizing animal tissues and their derivatives - Part 3: validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Edition 2008-03-01

Sterilization of health care products - Biological indicators - Part 8: method for validation of a reduced incubation time for a biological indicator
Edition 2021-07-28

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 medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Edition 2020-11-21

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2014-07-16

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
Edition 2019-11-20

Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2016-01-30

Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2 : Revision to 4.3.4 and 11.2
Edition 2019-11-20