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EN 13975:2003 Standard

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  Keywords:

#devices #statistical #used #procedures #sampling

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

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

  Purpose

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 11607-1:2020

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

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EN ISO 15223-1:2016

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

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN 14136:2004

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

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

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

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 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)

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