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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 11607-1:2009

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN 45502-2-3:2010

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Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

EN ISO 13485:2016

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

EN ISO 14155:2011

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

EN ISO 14155:2011/AC: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 14937:2009

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

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

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