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KATEGORIE: QUALITY SYSTEMS
Haltbarkeit
Der Zeitraum, in dem ein Medizinprodukt bei bestimmungsgemäßer Lagerung seine Sicherheit und Leistung beibehält.
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
- Identify aging mechanisms (sterile barrier, material degradation, software media, reagents).
- Design real-time and/or accelerated aging studies with acceptance criteria.
- Link packaging validation and sterilization residual studies to labeled expiry.
- 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.
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SOURCES
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