Stérilisation des dispositifs médicaux - Exigences pour les dispositifs médicaux étiquetés "stérile"
€56.50
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021
€128.22
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
€162.06
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/FDIS 17664-1:2020); German and English version prEN ISO 17664-1:2021
€111.40
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO/DIS 11138-8:2020); German and English version prEN ISO 11138-8:2020
€63.27
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
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
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
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022
€145.14
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022
€315.42
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023
€129.53
