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ISO 11607-2 AMD 1
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management
Edition
2023-09
ISO 45001 AMD 1
Occupational health and safety management systems - Requirements with guidance for use - Amendment 1: Climate action changes
Edition
2024-02
ISO 14971
Medical devices - Application of risk management to medical devices
Edition
2019-12
ISO 45006
Occupational health and safety management - Guidelines for organizations on preventing, controlling and managing infectious diseases
Edition
2023-12
ISO 22610
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
Edition
2018-09
ISO 11135 AMD 1
Revision of Annex E, Single batch release
Edition
2018-10
ISO 11137-1 AMD 2
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
2018-11
ISO 11137-2 AMD 1
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1
Edition
2022-06
ISO 17665
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition
2024-03
ISO 14160
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Edition
2020-09