What are the conditioning requirements for test specimens before ASTM F1929 testing?

When no specific conditioning requirements are given, and packaging materials are moisture-sensitive, a standard conditioning atmosphere of 23 ± 2°C (73.4 ± 3.6°F) and 50 ± 2% relative humidity is recommended for a minimum of 24 hours before testing.

Do we need to provide complete packaged devices for the test, or can we use empty packages?

Complete packaged devices are not always necessary for the test. The test specimen can consist of an entirely packaged device, empty packages, or edge seal samples. Blemished, rejected, or dummy products may be used if they will not affect test results and are recorded prior to the test.

Is your lab accredited to perform ASTM F1929 testing?

As an ISO/IEC 17025 accredited lab, Micom Laboratories is approved to perform ASTM F1929 testing on medical packaging. The FDA and Health Canada recognize ASTM F1929 as a consensus standard, which is important to consider when developing studies and validations.

Can this test be used as part of our package validation process for sterile barrier systems?

Yes, ASTM F1929 can be used as part of package validation processes for sterile barrier systems. It is designed to detect and locate leaks in package edge seals formed between a porous sheet material and a transparent material, which is relevant for medical packaging. Micom also offers ASTM F1980 testing services to evaluate the aging of sterile barrier systems for medical devices.

ASTM F1929 Testing Services for Medical Packaging

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Home » ASTM F1929

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