Space product assurance - Materials and hardware compatibility tests for sterilization processes; English version EN 16602-70-53:2015
Edition 2015-05

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
Edition 2011-10-01

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (Adopted ISO 11139:2018, first edition, 202018-08)
Edition 2019-06-01

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT)
Edition 2019-06-01

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12)
Edition 2021-05-01

Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Edition 2007-03-01

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01)
Edition 2016-07-01

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
Edition 2009-11-01

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03)
Edition 2017-08-01

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03)
Edition 2017-08-01