Sterilization of health care products — Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
€155.00
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices Amendment 1: Revision of Annex E, Single batch release
€21.00
Aseptic processing of health care products Part 6: Isolator systems
Sterilization of health care products — Biological indicators Part 7: Guidance for the selection, use and interpretation of results
€235.00
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
Sterilization of health care products — Microbiological methods Part 3: Bacterial endotoxin testing
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products Amendment 1
Aseptic processing of health care products Part 1: General requirements
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 (ISO 11137-1:2006/Amd 2:2018)
€20.00
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
€183.00
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023); German and English version prEN ISO 11737-3:2026
€167.66
Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination products
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 (ISO 11139:2018/Amd 1:2024)
€69.00
Aseptic processing of health care products Part 5: Sterilization in place
€115.00
Aseptic processing of health care products Part 4: Clean-in-place technologies
