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EN ISO 17665-1:2006 Standard

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  Keywords:

#medical #devices #sterilization #health #care

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

  Purpose

This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 554:1994"

Anyway is still possible use the "EN 554:1994" until August 31st, 2009

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EN ISO 11737-2:2009

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