Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
€261.00
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
€208.00
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
€21.00
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
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
€166.00
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
€20.00
Sterilization of health care products — Microbiological methods Part 3: Bacterial endotoxin testing
€235.00
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 - 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)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
€92.00
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026); German and English version prEN ISO 11737-1:2026
€173.74
Aseptic processing of health care products Alternative processes for medical devices and combination
€269.00
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
€316.00
