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CATÉGORIE: QUALITY SYSTEMS

Durée de conservation

La période pendant laquelle un dispositif médical maintient sa sécurité et ses performances dans les conditions de stockage spécifiées.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Shelf-life claims define how long a device remains safe and effective in its packaging under specified storage conditions—critical for sterile, chemical, battery-powered, and degradable devices.

PROCESS / STEPS

  1. Identify aging mechanisms (sterile barrier, material degradation, software media, reagents).
  2. Design real-time and/or accelerated aging studies with acceptance criteria.
  3. Link packaging validation and sterilization residual studies to labeled expiry.
  4. Control labeled storage conditions and justify extensions with data.

EXAMPLES

  • A sterile single-use kit may claim 3-year shelf life after real-time aging of the sterile barrier system.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Validation de stérilisationBonnes pratiques de fabrication (BPF)