Overview
EN ISO 23640:2015 (identical to ISO 23640:2011) defines requirements for the evaluation of stability of in vitro diagnostic (IVD) reagents. It applies to reagents, calibrators, control materials, diluents, buffers, reagent kits and specimen-collection devices that contain preservatives or reaction-initiating substances. The standard sets out how manufacturers should generate and justify data to support claims such as shelf life, transport conditions, and in‑use/open vial stability for IVD medical devices.
Key topics and technical requirements
- Scope and definitions: Clear terms for stability, shelf life, expiry date, batch/lot, real time and accelerated stability evaluation.
- General requirements: Stability claims must be justified by adequate data and appropriate risk assessment (see ISO 14971 reference).
- Stability study types:
- Real‑time stability evaluation - studies under the manufacturer’s specified storage and use conditions to establish shelf life.
- Accelerated stability evaluation - stress studies (e.g., temperature, humidity, light, vibration) designed to increase degradation rate to predict shelf life (Arrhenius concepts referenced).
- In‑use/open vial/on‑board stability - stability after first opening, reconstitution or placement on instrument.
- Applications for stability data:
- Establishing initial expiry dates and storage/transport limits.
- Monitoring reagents already on the market (post‑market surveillance of stability).
- Verification of stability after formulation, packaging or process changes that could affect performance.
- Traceability and batch control: Use of batch codes/lot numbers to link stability data to manufacturing history.
- Regulatory linkage: Annex ZA relates the standard to Essential Requirements of EU Directive 98/79/EC for IVDs.
Practical applications and users
Who uses EN ISO 23640:2015:
- IVD manufacturers - design and validate stability studies, assign expiry dates, and prepare regulatory submissions.
- Quality assurance and regulatory affairs teams - compile stability evidence for conformity with EU directives and national regulations.
- R&D and formulation scientists - plan accelerated and real‑time studies to optimise product stability.
- Clinical laboratories and distributors - understand transport/storage limits and in‑use stability statements.
- Notified bodies and auditors - assess manufacturer compliance with stability evaluation practices.
Practical benefits:
- Provides a standardized framework for generating robust stability evidence.
- Helps ensure IVD reagent performance is maintained throughout shelf life and transport.
- Supports regulatory compliance and risk‑based decision making.
Related standards
- ISO 14971 - medical device risk management (normative reference in EN ISO 23640).
- EN 13640 - earlier basis for IVD reagent stability testing (historical reference).
- EU Directive 98/79/EC - Annex ZA maps clauses to essential requirements for IVD devices.
Keywords: EN ISO 23640:2015, ISO 23640:2011, stability evaluation, IVD reagents, shelf life, real time stability, accelerated stability, in vitro diagnostic medical devices.
