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ISO 10993-1 and Biocompatibility

Guidelines on conducting a biological evaluation of a medical device

Manager reviewing reports by laying them out on a table

Manufacturers are required to thoroughly assess a medical device's biological safety before placing it on the market in many regulated nations to reduce the danger of bio-incompatibility with the human body. This presents the ISO 10993 series as an international standard accepted in many nations, including Europe, the United States, and others.

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