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
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Aseptic processing of health care products Part 6: Isolator systems
€155.00
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
€208.00
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
Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
€235.00
Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination products
Sterilization of health care products — Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
€183.00
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Aseptic processing of health care products Part 5: Sterilization in place
€115.00
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
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
