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ADA 41-2015

ADA 41-2015 Evaluation of Biocompatibility of Medical Devices Used in Dentistry

standard by American Dental Association, 12/23/2015

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This standard covers standard practices for the biological evaluation of the safety of medical devices used indentistry. In addition, this document covers biological evaluation of the device component of combinationproducts, including those with a pharmacological agent or biologic component as an integral part of thedevice.

This standard does not cover testing of materials and devices that do not come into direct or indirect contactwith the patient's body.

 
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