Draft
International Standard
ISO/DIS 23640
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
Reference number
ISO/DIS 23640
Edition 2
© ISO 2026
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 23640:2011

ISO/DIS 23640

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CHF 67
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Abstract

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.

General information

  • Status
     : Under development

    You can help develop this draft international standard by contacting your national member

    Stage
    : DIS ballot initiated: 12 weeks [40.20]
  • Edition
     : 2
    Number of pages
     : 12
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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