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The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact  with the human body. This document specifically covers the use of ISO 10993-1 but also is relevant to other biocompatibility standards (e.g., other parts of the ISO4 10993 series of standards, ASTM, ICH,  OECD,  USP

This document discusses the following topics:

• use of risk assessments for biocompatibility evaluations for a proposed medical device;
• use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints for an evaluation;
• general biocompatibility testing considerations, including test article preparation;
• specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments

• chemical assessment recommendations;
• considerations for labeling devices as “-free.”


Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”