ISO 14937:2009
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Standard No.
ISO 14937:2009
Release Date
2009
Published By
International Organization for Standardization (ISO)
Latest
ISO 14937:2009

ISO 14937:2009 Referenced Document

  • ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*2018-08-01 Update
  • ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
  • ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*2014-11-01 Update
  • ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*2021-05-19 Update
  • ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*2019-12-02 Update
  • ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 14937:2009 history

  • 2009 ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • 2003 ISO 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
  • 2000 ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices



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