Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
€124.00
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
€235.00
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards Amendment 1: Amended and additional terms and definitions
€21.00
Sterilization of health care products — Biological indicators Part 7: Guidance for the selection, use and interpretation of results
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 2: Non-critical medical devices
€155.00
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
€261.00
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
€208.00
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1: Critical and semi-critical medical devices
€178.00
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose Amendment 1
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices Amendment 1
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
€58.00
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
€166.00
