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EN 556-1:2001/AC:2006 Standard

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  Keywords:

#devices #medical #european #standard #specifies

  Directive

Medical devices Directive (93/42/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

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EN 1641:2009

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EN 1642:2011

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EN 1707:1996

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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

EN 1865-3:2012

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Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

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