NF EN ISO 23640

NF EN ISO 23640

December 2015
Standard Current

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2015

Number of pages

15 p.

Reference

NF EN ISO 23640

ICS Codes

11.100.10   In vitro diagnostic test systems
71.040.30   Chemical reagents

Classification index

S92-032

Print number

1

International kinship

ISO 23640:2011

European kinship

EN ISO 23640:2015
Sumary
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

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.
Replaced standards (1)
NF EN ISO 23640
March 2014
Standard Cancelled
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

<p>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. </p> <p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:</p> <ul> <li> the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; </li> <li> the establishment of stability of the IVD reagent in use after the first opening of the primary container;</li> <li> the monitoring of stability of IVD reagents already placed on the market;</li> <li> the verification of stability specifications after modifications of the IVD reagent that might affect stability.</li> </ul>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Modes opératoires
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 98/79/CE
  • Bibliographie
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