ISO 23640:2011

Overview

ISO 23640:2011 - "In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents" - defines requirements for designing, performing and reporting stability evaluations of in vitro diagnostic (IVD) reagents. It applies to reagents, calibrators, control materials, diluents, buffers, reagent kits and specimen collection devices that contain stabilizing or reactive substances. The standard supports establishing shelf life, transport and in‑use stability (e.g., open-vial or reconstituted stability), post‑market monitoring, and verification after product changes.

Key topics and technical requirements

• Stability evaluation scope: Real‑time and accelerated stability studies to justify expiry dates, transport conditions, and in‑use claims.
• Protocol requirements: Pre‑established protocol must document responsibilities, clear reagent identification, use conditions, objectives, sample information (batch/lot), critical components, storage and transport simulations, sampling intervals, examinations, data analysis methods, acceptance criteria and interpretation.
• Study design: Minimum batch numbers defined by objective - typically 3 batches for new shelf‑life or extensions (real‑time), and 1 batch for transport simulation, in‑use stability or certain post‑modification checks (risk‑based exceptions allowed).
• Accelerated studies: Acceptable for initial expiry dating where appropriate; analysis may use Arrhenius plots or non‑linear modelling. Accelerated data must be confirmed by real‑time studies when used for market introduction.
• Data and reporting: Stability reports must reference the protocol, batches tested, all results, data analysis, pass/fail against acceptance criteria and final conclusions.
• Risk management: Link to ISO 14971 for assessing when fewer batches or altered conditions are justified; manufacturers must assess risks from labile components and production differences.
• Post‑market: Requirement to establish stability monitoring where necessary and to reassess stability after manufacturing or product modifications.

Applications

• Establishing and documenting shelf life and expiry dates for IVD reagents and kits.
• Defining transport conditions (temperature, humidity, vibration) that preserve reagent performance.
• Demonstrating in‑use stability (on‑board, reconstituted, open vial) for clinical laboratories and point‑of‑care devices.
• Supporting regulatory submissions, technical documentation and quality systems by providing validated stability data.
• Guiding stability monitoring and verification after product changes or during post‑market surveillance.

Who should use this standard

• IVD manufacturers (R&D, quality assurance, regulatory affairs)
• Stability study designers and laboratory scientists
• Clinical laboratories assessing reagent claims
• Regulatory bodies reviewing IVD technical documentation

Related standards

• ISO 14971 (risk management for medical devices)
• CLSI EP25‑A (guidance on stability evaluation methods)
• EN 13640 (basis for ISO 23640)

Keywords: ISO 23640, in vitro diagnostic reagents, stability evaluation, shelf life, accelerated stability, real‑time stability, transport stability, in‑use stability, stability protocol.