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Shelf-life Verification Guide

Use this Shelf-life Verification Guide template to plan and document the necessary testing for medical device shelf-life claims, covering both accelerated and real-time aging methods to ensure packaging and device integrity over the intended storage period. Complete this guide before engaging a contract laboratory, as it helps define the testing approach, intervals, and required outcomes for regulatory compliance. Fill out this document when you need to establish or validate the expiration date of your medical device as part of your technical documentation or regulatory submission.
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This is just a guide for you to perform your shelf-life verification testing and does NOT need to be approved. Review it and find a contract laboratory to do the testing using the guide as a reference.

Shelf-life Verification Guide

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1. Purpose

To investigate the integrity of the packaging and medical device under real, simulated, and/or storage conditions.

2. Scope

Applies to all medical devices requiring shelf-life verification as part of regulatory compliance.

3. Definitions

  • Real-Time Aging (RTA): Testing under storage conditions representative of normal storage conditions over the intended shelf life.
  • Accelerated Aging (AA): Testing using elevated environmental conditions to simulate the aging process over a shorter time.

4. References

This protocol is developed with following standards considered:

  • ISO 13485: Quality management systems for medical devices.
  • IEC 60601-1: General safety requirements for medical electrical equipment.
  • ASTM F1980: Accelerated Aging of Packaging Materials
  • ISO 11607-1: Packaging for terminally sterilized medical devices.

5. Test Protocol

5.1 Outcomes

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5.2 Accelerated Aging

Introduction

Accelerated aging is used to simulate the long-term effects of real-time aging by exposing the device to elevated temperatures. This approach follows the Arrhenius model to estimate material and product degradation over time.

AAF (Accelerated Aging Factor) Calculation

The AAF is calculated using the Arrhenius-based formula:

AAF = Q₁₀^((TAA - TRT) / 10)

Where:

  • TAA = Accelerated aging temperature (e.g., 55°C)
  • TRT = Real-time ambient temperature (e.g., 25°C)
  • Q₁₀ = Reaction rate factor (typically 2 unless otherwise justified)

Example Calculation:

If TAA = 55°C, TRT = 25°C, and Q₁₀ = 2:

  • AAF = 2^((55 - 25)/10) = 2³ = 8

Duration of Accelerated Aging:

To estimate the required duration of accelerated aging:

  • AA Duration = Real-Time Shelf Life (days) / AAF

Example:

For a 5-year shelf life (1825 days) and an AAF of 8:

  • AA Duration = 1825 / 8 = ~228 days (~7.5 weeks)

Testing Intervals:

Testing is performed at the end of the accelerated aging period to confirm that the device still meets functional and performance requirements.

Additional intervals (e.g., midpoint assessments) may be included based on specific risks or product complexity.

5.3 Real-Time Aging

Introduction
Real-time aging is performed to confirm that the device maintains its functionality, safety, and performance over the claimed shelf life when stored under normal ambient conditions. It serves as the confirmatory method for shelf-life validation and complements any accelerated aging data submitted prior to full shelf-life duration.

Storage Condition
Devices shall be stored under controlled conditions representative of typical ambient storage. Unless otherwise justified, the standard storage temperature is assumed to be 23–25°C with relative humidity of 50–60%.

Duration
Devices shall be aged for the full duration of the claimed shelf life (e.g., 1 year, 2 years, etc.). Periodic inspection may be performed during the aging period, but testing is required at the end of the defined shelf-life interval.

Testing Intervals
Final testing is performed at the end of the real-time aging period. Intermediate timepoints may be included based on product risk, degradation concerns, or regulatory strategy.

Post-RTA Testing
Devices subjected to real-time aging shall undergo the same testing as those aged under accelerated conditions. This includes verification of functional performance, material integrity, labeling durability, and other device-specific attributes defined in the test plan. Testing must demonstrate that the product continues to meet its intended performance and safety specifications after the full duration of storage.

Medical Device Certification Made Easy.