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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

  Related Standards

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EN ISO 10993-1:2009

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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN 1041:2008

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Information supplied by the manufacturer of medical devices

EN 556-2:2015

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Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN 556-1:2001/AC:2006

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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

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