Biocompatibility & analysis of medical devices according to ISO 10993 - Stability of reagents for in vitro diagnostic (IVD)

Inge  Bondgaard

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Biocompatibility & analysis of medical devices according to ISO 10993 - Stability of reagents for in vitro diagnostic (IVD)

In vitro diagnostic medical devices are covered by the IVD Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

A critical aspect of the development and production of in vitro diagnostic (IVD) reagents for medical devices is ensuring and documenting the stability of the IVD reagents so a correct diagnosis can be made, and subsequent treatment can be ensured.


  • It is important to test the stability of the final product to confirm its durability.
  • It is recommended to test the stability during product development, so the development of a stable IVD product is ensured.


Factors affecting the IVD stability

When testing the stability, it is important to identify all factors that can influence the IVD reagent, so they can be considered during stability testing, e.g., temperature, humidity, storage time, and sensitivity to light or oxygen.

IVD stability is crucial for making the correct diagnosis, and therefore it is necessary to examine and document the storage stability, transport stability, and stability when the packaging has been broken to provide the correct instructions for storage and handling of the IVD reagent.


Testing stability of IVD according to EN ISO 23640

The stability study of the final product is carried out according to EN ISO 23640 and stability must be documented by:

  • Storage stability in original packaging.
  • Transport stability in original packaging or other relevant containers.
  • Stability during use when the original packaging has been broken.


How can Danish Technological Institute help you?

Danish Technological Institute has methods and equipment for examining, e.g.:

  • Stability testing of IVD reagents according to EN ISO 23640
  • Material compatibility between material and IVD reagents
  • Release of particles
  • Strategy and planning of tests