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ASTM International Packaging Standard Will Aid Medical Devices Industry


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, ultimately helping support quality and safety of products. 

According to ASTM International member Daniel Burgess of Boston Scientific, 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 make suggestions for future revisions.

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

For a downloadable infographic showing how standards support innovation in health and medicine, see this page.

To purchase standards, contact ASTM International customer relations (tel +1.877.909.ASTM;

Media Inquiries: Dan Bergels, tel +1.610.832.9602;
Committee Contact: James Farrell, tel +1.610.832.9661; 

Release #10494

March 5, 2018

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