Work with a testing lab to determine the best specs. There isn't a predetermined size, it depends on the contact, the test, and the levels of exposure desired. But, without question, the coupon has to have all of the material, in roughly proportionate volumes and all final processing to be considered valid for biocompatibility testing.
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Lisa Olson
RCRI - ENTERPRISE
Minneapolis MN
United States
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Original Message:
Sent: 06-Feb-2018 15:17
From: Lori Burns
Subject: Biocompatibility Coupon
Does anyone know how to estimate the size of a coupon for biocompatibility testing representative of an implantable medical device?
 | Lori Burns | Director, Regulatory Affairs
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Avenue | Audubon, PA 19403
Ph: (610) 930-1800 ext. 2950 | Fax: 610-930-2042
An ISO 13485 Registered Company
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