Need help?

EN ISO 17665-1:2006 Standard

wave
Save  

  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

EN 62304:2006/AC:2008

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

Medical device software - Software life-cycle processesIEC 62304:2006

EN ISO 11607-2:2020

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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 14155:2011

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

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 13485:2016

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

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13408-7:2015

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

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0