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Standards [CURRENT]

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

Standards [CURRENT]

ISO 45001 AMD 1

Occupational health and safety management systems - Requirements with guidance for use - Amendment 1: Climate action changes
Edition 2024-02

Standards [CURRENT]

ISO 14971

Medical devices - Application of risk management to medical devices
Edition 2019-12

Standards [CURRENT]

ISO 45006

Occupational health and safety management - Guidelines for organizations on preventing, controlling and managing infectious diseases
Edition 2023-12

Standards [CURRENT]

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

Standards [CURRENT]

ISO 11135 AMD 1

Revision of Annex E, Single batch release
Edition 2018-10

Standards [CURRENT]

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

Standards [CURRENT]

ISO 11137-2 AMD 1

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1
Edition 2022-06

Standards [CURRENT]

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

Standards [CURRENT]

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

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