Health Care and Medical Devices

Origin: ISO
Close date: Jan 23, 2021
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ISO 11137-4 provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

Origin: ISO
Close date: Jan 23, 2021
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Adoption of ISO 11737-2-2019, Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Origin: ISO
Close date: Jan 23, 2021
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Adoption of ISO 11607-1-2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Origin: ISO
Close date: Jan 23, 2021
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The ISO 11607-2 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.