ASTM International’s medical and surgical devices committee (F04) has approved a new standard that provides details and considerations for planning and conducting a seal zone leakage assessment for stent grafts.
According to ASTM member Lucas Chavez-Pardini, the new standard (soon to be published as F3849) will be used by commercial and new product development quality engineers evaluating stent graft devices for medical device companies.
The new standard will also be used by contract testing companies that fulfill ISO testing requirements for medical device submissions. It will also help drive alignment and understanding between regulatory bodies and device manufacturers as to the accepted practices for fulfilling the seal zone leakage test for stent graft devices.”
Chavez-Pardini, Member, ASTM International
This effort directly relates to the United Nations Sustainable Development Goal #3 on good health and well-being.
Users of the new standard are encouraged to contact the F04 committee with any feedback that could be helpful for future editions.
ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.
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