All terms
Quality & RiskQuality System
Shelf Life
Period during which a device remains suitable for its intended use under specified conditions.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Shelf life is supported by accelerated aging and real-time aging studies, often per ASTM F1980, that demonstrate package integrity and product performance over time.What this means in practice
Shelf-life claims appear in labeling and must be supported by valid data. Extension studies are common as real-time data accumulates.Mentioned in recent activity
10 entriesCOOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Class II· 2026-03-05
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Class II· 2026-03-05
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Class II· 2026-03-05
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Class II· 2026-03-05
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
ASTM·1MDIC·1FDA·1
- 1
ASTM F1980VerifiedASTMastm.org
- 2
MDIC Case for QualityVerifiedMDICmdic.org
- 3
FDA - Quality SystemsVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.