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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
60.60 Standard published
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
60.60 Standard published
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
60.60 Standard published
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
60.60 Standard published
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
60.60 Standard published
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
60.60 Standard published
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
60.60 Standard published
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
60.60 Standard published
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005/Amd 1:2013)
60.60 Standard published
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
General requirements for in vitro diagnostic medical devices for self-testing
60.60 Standard published
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published
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