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EN 556-1:2001/AC:2006 Standard

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  Keywords:

#devices #medical #european #standard #specifies

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th 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 20776-1:2006

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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN 13975:2003

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

EN 13641:2002

In vitro diagnostic medical devices Directive (98/79/EC)

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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