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EN ISO 23640:2015 Standard

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  Keywords:

#ivd #reagent #evaluation #specifications #collection

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

  Purpose

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device. ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; the establishment of stability of the IVD reagent in use after the first opening of the primary container; the monitoring of stability of IVD reagents already placed on the market; the verification of stability specifications after modifications of the IVD reagent that might affect stability.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 13640:2002"

Anyway is still possible use the "EN 13640:2002" until June 30th, 2017

  Related Standards

EN 13641:2002

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

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EN 13532:2002

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Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002/AC:2002

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Performance evaluation of in vitro diagnostic medical devices

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

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