IVD and Laboratories
ISO 23640: Stability Evaluation of IVD Reagents
ISO 23640 covers the stability evaluation of in vitro diagnostic reagents, including calibrators and control materials. It describes how to establish and verify stability claims such as shelf life, in-use stability after opening or loading onto an instrument, and stability during transport.
At a Glance
- Standard
- ISO 23640
- Subject
- Stability Evaluation of IVD Reagents
- Group
- IVD and Laboratories
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
A stability claim starts with a plan: the claim being supported, acceptance criteria tied to performance, the storage conditions tested, the lots, the time points and the measurement approach. Real-time studies at the labeled storage conditions establish shelf life. Accelerated studies can give an early estimate, but they generally need confirming with real-time data.
In-use stability covers what happens after the product is opened, reconstituted or loaded onto an analyzer, and it often matters more to the user than shelf life does. Transport stability addresses the shipping conditions the product will actually meet, including temperature excursions.
Stability evidence flows into labeling and production. Expiry dates, storage conditions and in-use claims in the labeling have to match the reports, and changes to formulation, packaging, raw material suppliers or manufacturing processes can invalidate a stability claim, so they need assessing before release.
Who It Applies To
- Manufacturers of IVD reagents, calibrators and control materials
- Firms extending shelf life or changing storage conditions
- Changes to formulation, packaging or raw material suppliers
- Products shipped through variable climates or long distribution chains
What Auditors Check
Stability Protocols
Approved protocols with predefined acceptance criteria, time points and the method of analysis.
Lot Selection
A rationale for the lots studied and evidence that they represent production.
Real-Time Confirmation
Real-time data confirming any shelf life claim that was first set from accelerated studies.
In-Use and Transport Data
Studies supporting the open-vial, on-board and shipping claims made in the labeling.
Change Impact Assessment
Records showing formulation, packaging and supplier changes were assessed for their effect on stability.
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Industry Guides That Reference ISO 23640
ISO 23640
Check Your Quality System Against ISO 23640
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