ASTM F1980 : 21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

Standard Details

1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.

1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.

1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.

1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.

1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.

1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”

1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems.

1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International StandardDetails, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

What ASTM F1980 means for medical device packaging shelf life

ASTM F1980 is the Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. It provides a scientific approach to simulate long-term aging of medical device packaging so manufacturers can estimate shelf life without waiting for real-time aging data to accumulate. Accelerated aging tests are widely accepted by regulators and auditors as supportive evidence for claimed shelf life. :contentReference[oaicite:1]{index=1}

Video credit: Packaging Compliance Labs on YouTube.

It provides a scientific method to simulate long-term material aging in a shorter timeframe. :contentReference[oaicite:2]{index=2}
It supports shelf-life claims for sterile barrier systems and packaged devices. :contentReference[oaicite:3]{index=3}
It helps packaging engineers predict performance and durability over time. :contentReference[oaicite:4]{index=4}

Core building blocks of ASTM F1980

Accelerated aging principle: uses elevated temperatures to speed up degradation reactions that normally occur slowly over real time. :contentReference[oaicite:5]{index=5}
Arrhenius theory and aging factor (AAF): the Arrhenius equation predicts how aging accelerates with temperature increases. :contentReference[oaicite:6]{index=6}
Aging temperature and duration: chosen to simulate specific real-world shelf life using calculated aging factors. :contentReference[oaicite:7]{index=7}
Controlled environmental conditions: temperature (and optionally humidity) are maintained during the entire aging period. :contentReference[oaicite:8]{index=8}
Post-aging evaluation: integrity, seal strength, and package performance are tested at the end of the aging cycle. :contentReference[oaicite:9]{index=9}

Video credit: Packaging Compliance Labs on YouTube.

How accelerated aging works under ASTM F1980

Select the desired real-time shelf life you want to simulate (for example, 2 or 5 years). :contentReference[oaicite:10]{index=10}
Choose an elevated aging temperature (commonly 50°C, 55°C, or 60°C) based on material stability. :contentReference[oaicite:11]{index=11}
Use the Arrhenius-based aging factor (AAF) formula to calculate the accelerated aging time. :contentReference[oaicite:12]{index=12}
Expose samples to controlled temperatures for the calculated time. :contentReference[oaicite:13]{index=13}
Evaluate packaging integrity and performance after aging. :contentReference[oaicite:14]{index=14}

High-value use cases of ASTM F1980

Validating the shelf life of sterile medical device packaging. :contentReference[oaicite:15]{index=15}
Supporting regulatory submissions like FDA 510(k) tech files. :contentReference[oaicite:16]{index=16}
Comparing packaging materials during design selection. :contentReference[oaicite:17]{index=17}
Evaluating effects of time on seal strength and material degradation. :contentReference[oaicite:18]{index=18}
Documenting stability evidence for notified bodies and auditors. :contentReference[oaicite:19]{index=19}

Integration with packaging and sterilization standards

Complementary to ISO 11607 for terminal sterile packaging. :contentReference[oaicite:20]{index=20}
Works with ISO 11137 & ISO 11135 sterilization standards for overall device validation. :contentReference[oaicite:21]{index=21}
Supports regulatory expectations for shelf-life data. :contentReference[oaicite:22]{index=22}

How to apply ASTM F1980 in a validation program

Define your claimed shelf life and target storage conditions. :contentReference[oaicite:23]{index=23}
Calculate the accelerated aging time using AAF and temperature assumptions. :contentReference[oaicite:24]{index=24}
Perform controlled exposures in environmental chambers. :contentReference[oaicite:25]{index=25}
Test for seal strength, integrity, and performance post-aging. :contentReference[oaicite:26]{index=26}
Maintain documentation for regulatory submissions. :contentReference[oaicite:27]{index=27}

Deployment timeline and validation benchmarks

Week 1: define aging parameters and protocol. :contentReference[oaicite:28]{index=28}
Weeks 2–6: run accelerated aging exposures. :contentReference[oaicite:29]{index=29}
Weeks 6–8: post-aging evaluation and testing. :contentReference[oaicite:30]{index=30}
Ongoing: real-time aging confirmation studies. :contentReference[oaicite:31]{index=31}

Common pitfalls and how to avoid them

Using aging temperatures that exceed material heat tolerance, causing unrealistic degradation. :contentReference[oaicite:32]{index=32}
Failing to justify accelerated conditions with scientific rationale. :contentReference[oaicite:33]{index=33}
Not performing post-aging functional tests. :contentReference[oaicite:34]{index=34}
Skipping real-time aging confirmation. :contentReference[oaicite:35]{index=35}
Ignoring controlled humidity when material moisture sensitivity is significant. :contentReference[oaicite:36]{index=36}

Frequently Asked Questions

1. What does ASTM F1980 cover?
ASTM F1980 defines accelerated aging methods that simulate long-term shelf life effects using elevated temperature protocols to predict medical device packaging performance. :contentReference[oaicite:37]{index=37}

2. Is accelerated aging sufficient to prove shelf life?
Accelerated aging provides supportive evidence for shelf-life claims, but regulators generally expect real-time aging studies to confirm predictions. :contentReference[oaicite:38]{index=38}

3. What temperatures are typically used?
Common accelerated aging temperatures are 50°C, 55°C, and 60°C, chosen based on material stability. :contentReference[oaicite:39]{index=39}

4. Do I need to control humidity?
ASTM F1980 states controlled humidity can be considered if materials are moisture-sensitive; otherwise, ambient humidity may suffice. :contentReference[oaicite:40]{index=40}