Plan systematic aging studies validating device stability and performance throughout storage periods.
Tested Attribute | Test Method | Acceptance Criteria |
---|---|---|
Glucose Measurement Accuracy | ISO 15197:2013 accuracy testing | Within ±15% or ±15 mg/dL of reference value |
Strip Physical Integrity | Visual inspection and handling test | No cracks, delamination, or color changes |
Package Seal Integrity | Bubble emission test per ASTM F2096 | No bubble emission indicating seal failure |
Label Durability | Visual inspection and barcode scan | All text legible, barcode scannable |
Reagent Activity | Enzymatic activity assay | ≥90% of initial activity level |
How do I determine the appropriate accelerated aging temperature?
What if my accelerated aging results don't match real-time aging results?
How many samples do I need for shelf life testing?
Can I use accelerated aging data to support initial market entry?
What storage conditions should I use for real-time aging?
How do I handle test failures during shelf life studies?