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Find out what biocompatibility (ISO 10993) tests your device needs

MEDICAL DEVICE AND ITS BIOCOMPATIBILITY TESTING REQUIREMENT TABLE AS PER FDA 510 (K) G95-MEMORANDUM AND ISO 10993-1

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X = Tests per ISO 10993-1
O = Additional tests that may be applicable in the U.S.
Note1 – Tissue includes tissue fluid and subcutaneous spaces
Note2 – For all devices used in extracorporeal circuits