Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German version EN ISO 13004:2023
€162.06
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); German and English version prEN ISO 17664-2:2023
€116.64
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 (ISO 25424:2018/DAM 1:2021); German and English version EN ISO 25424:2019/prA1:2021
€63.27
Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English.
€98.32
Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English.
€128.22
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021
€230.84
Sterilization of health care products - Chemical indicators - Part 6: Class 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO/DIS 11140-6:2021); German and English version prEN ISO 11140-6:2021
€134.02
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 (ISO 14160:2020); German version EN ISO 14160:2021
€140.00
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021
€69.91
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 (ISO 17664-1:2021); German version EN ISO 17664-1:2021
€111.40
Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; Text in German and English
€77.20
Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German and English version prEN 17846:2022
€122.34
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023
€195.79
Aseptic processing of health care products - Part 1: General requirements (ISO/DIS 13408-1:2021); German and English version prEN ISO 13408-1:2021
€214.30
