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EN 14136:2004 Standard

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  Keywords:

#assessment #called #hereafter #medical #devices

  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

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EN 13641:2002

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

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN ISO 20776-1:2006

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

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of p...

EN ISO 18153:2003

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

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for ca...

EN ISO 18113-5:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

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