Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)
Edition 2021-05-01

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)
Edition 2021-05-01

Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)
Edition 2021-08-01

Medical laboratories - Requirements for safety (Adopted ISO 15190:2020, second edition, 2020-02)
Edition 2021-02-01

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
Edition 2023-05-01

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)
Edition 2023-05-01

Requirements for the collection and transport of samples for medical laboratory examinations (Adopted ISO 20658:2023, first edition, 2023-05)
Edition 2024-03-01

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

Medical laboratories - Application of risk management to medical laboratories (Adopted ISO 22367:2020, first edition, 2020-02)
Edition 2021-05-01

The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 standard for medical laboratories
Edition 2010-11-01