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/Amd 1:2013)
€50.00
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
€58.00
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 1:2014)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
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)
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
€121.00
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 (ISO 11140-4:2007)
€142.00
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 (ISO 17664-2:2021)
€124.00
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods