Summary

Specifies requirements for the development, validation, and routine control of a moist heat (steam/autoclave) sterilization process for medical devices and health care products. Covers saturated steam sterilization and air-steam mixtures.

Standard Details

Standard Number: ISO 17665-1:2006
Type: Sterilization Standard
Published by: ISO
Official Link: https://www.iso.org/standard/43187.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 17665-1:2006 — Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control

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