Summary

Provides the general framework for characterizing a sterilizing agent and for the development, validation, and routine control of a sterilization process. Applicable to novel sterilization methods not covered by specific standards (ISO 11135, ISO 11137, ISO 17665).

Standard Details

Standard Number: ISO 14937:2009
Type: Sterilization Standard
Published by: ISO
Official Link: https://www.iso.org/standard/44954.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 14937:2009 — Sterilization of health care products — General requirements for characterization of a sterilizing agent

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