ISO 23640 is officially titled:
"In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents"
These international standard outlines procedures and requirement to determine the stability of IVD reagents, including:
The standard applies to all types of IVD medical devices—manual or automated—used in clinical laboratories, point-of-care settings, or home diagnostics.
It is essential for manufacturers who want to:
Unstable IVD products can cause:
ISO 23640 mitigates these risks by providing:
Implementing ISO 23640 provides significant benefits to manufacturers, laboratories, and patients:
Establish expiration dates based on scientific evidence and usage patterns.
Ensure consistency of analytical sensitivity and specificity over time.
Minimize product degradation during distribution and use.
Use stability studies to guide formulation, packaging, and logistics.
Satisfy FDA, EU IVDR, WHO, and other global regulatory bodies.
Partnering with GMC for ISO 23640 implementation positions your organization for market success:
Meet technical file requirements for CE marking, FDA 510(k), and WHO prequalification.
Reduce the risk of product complaints, test failures, and recalls.
Align with ISO 13485, ISO 17511, and IVDR performance requirements.
Extend shelf life and reduce expired stock issues through accurate testing.
Demonstrate product reliability across diverse climate zones and healthcare settings.
Deliver products that perform reliably throughout their life cycle.
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