ISO 25424:2018
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

Standard No.
ISO 25424:2018
Release Date
2018
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 25424:2018/Amd 1:2022
Latest
ISO 25424:2018/Amd 1:2022

ISO 25424:2018 Referenced Document

  • ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
  • ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
  • ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
  • ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 25424:2018 history

  • 2022 ISO 25424:2018/Amd 1:2022 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
  • 2018 ISO 25424:2018 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • 2009 ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices



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