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EN 556-1:2001/AC:2006 Standard

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  Keywords:

#devices #medical #european #standard #specifies

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

  Purpose

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE': Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 556-1:2001"

  Related Standards

EN ISO 10993-5:2009

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

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 13408-4:2011

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

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN ISO 25424:2019

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Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN ISO 13485:2016/AC:2018

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

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

EN ISO 13408-2:2018

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

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN ISO 11137-1:2015/A2:2019

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

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

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