Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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 (ISO 14937:2009)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Information supplied by the manufacturer of medical devices
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