Aseptic processing of health care products Part 4: Clean-in-place technologies
€115.00
Aseptic processing of health care products Part 3: Lyophilization
€77.00
Sterilization of health care products — Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
€155.00
Sterilization of health care products — Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
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 Part 1: General requirements
Sterilization of health care products — Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
€21.00
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 — Vocabulary of terms used in sterilization and related equipment and process standards Amendment 1: Amended and additional terms and definitions
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
€184.00
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
€20.00
