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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

EN ISO 13485:2016/AC:2018

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

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

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN ISO 15193:2009

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

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and pre...

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 14937:2009

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

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

EN 14254:2004

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

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

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