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EN 14136:2004 Standard

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  Keywords:

#assessment #hereafter #called #european #standard

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

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

  Purpose

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs).

  Publication

Friday 17th of November 2017

  Related Standards

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-1:2001/AC:2006

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-2:2015

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

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN ISO 11137-2:2015

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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 11737-2:2009

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

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

EN 12322:1999

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

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

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