2024年4月7日发(作者：)

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ASTM F1980-2023 Specification for Accelerated Aging of Sterile

Medical Device Packages

Introduction

ASTM F1980-2023 is the standard specification for

accelerated aging of sterile medical device packages. This

specification provides guidelines for conducting accelerated

aging tests to determine the shelf life of sterile medical device

packages. Accelerated aging tests can help predict the effects of

time on the sterile barrier system over the projected shelf life.

This standard is applicable to packages made of various

materials such as films, foils, and papers.

Scope

This specification covers the minimum requirements for

accelerated aging of sterile medical device packages. It

provides guidelines on the selection of test parameters,

accelerated aging methods, and the interpretation of test

results. The objective of this standard is to ensure that the

sterile barrier system maintains its integrity and functionality

over the intended shelf life.

Test Methods

The accelerated aging test involves subjecting the sterile

medical device packages to elevated temperatures and

humidity conditions for a specified period. This test simulates

the aging process and provides an estimate of the shelf life of

the package. The following test methods are recommended:

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1. Test Specimen Preparation: The test specimens

should be prepared according to the manufacturer’s

instructions. The size and configuration of the specimens

should be representative of the package system.

2. Aging Conditions: The test specimens should be

exposed to elevated temperatures and humidity conditions.

The recommended aging conditions are 55 ± 2°C and 95%

relative humidity (RH). The exposure time for accelerated

aging may vary depending on the intended shelf life of the

package.

3. Monitoring: During the aging process, the test

specimens should be periodically inspected for any signs of

failure or degradation. This may include visual inspection,

seal integrity testing, microbial barrier testing, and physical

testing.

4. Test Period: The accelerated aging period should be

based on the intended shelf life of the package. The test

period is typically determined by multiplying the intended

shelf life by a factor derived from the Arrhenius equation.

The selection of the acceleration factor is based on the type

of material used in the package system.

Test Results

The test results should be evaluated based on the

acceptance criteria defined by the manufacturer. The

performance of the sterile barrier system should be assessed

by conducting various tests such as peel strength, burst

strength, microbial barrier testing, visual inspection, and

integrity testing. Any failure or degradation observed during

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the accelerated aging process should be documented and

reported.

Reporting

The test report should include the following information:

1. Identification of the package system and test

specimens.

2. Aging conditions and exposure time.

3. Monitoring and inspection procedures.

4. Test results including any failures or degradations

observed.

5. Discussion and interpretation of the test results.

6. Conclusion and recommendations for the shelf life of

the package.

Conclusion

ASTM F1980-2023 provides guidelines for conducting

accelerated aging tests on sterile medical device packages.

These tests can help determine the shelf life of the package by

simulating the effects of time on the sterile barrier system. By

following the procedures outlined in this specification,

manufacturers can ensure that their sterile medical device

packages maintain their integrity and functionality over the

intended shelf life. It is important to note that this standard

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should be used in conjunction with other relevant standards

and regulations applicable to sterile packaging.

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