ASTM International Packaging Standard to Aid Medical Devices Industry

To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.

To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.
To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.

ASTM International’s committee on primary barrier packaging (F02) has approved a new guide that will help validate test methods for packaging on medical devices.

This will help professionals who specify certain packaging as well as those who regularly test packaging, helping to support quality and the safety of products.

ASTM International member Daniel Burgess of Boston Scientific notes there had previously been no standard explicitly focused on validating packaging test methods. The new standard (soon to be published as F3263) will provide guidance specifically for validating attribute (pass/fail) and variable packaging test methods.

Burgess says that industry professionals are encouraged to participate in further development of the standard by making suggestions for future revisions.

A presentation on the topic will be given at the F02 committee 2018 fall meeting October 3-4 in Nice, France.

“More than 12,000 ASTM standards operate globally,” according to the organization’s website. “Committed to serving global societal needs, ASTM International impacts public health and safety, consumer confidence, and overall quality of life. We integrate consensus standards—developed with our international membership of volunteer technical experts—and innovative services to improve lives,” says the organization.

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