ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process

Does your medical device come into direct or indirect contact with the human body?   If so, the FDA has released a guidance document on the Use of International Standard ISO 10993-1. This guidance will help you determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.  The scope is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body.  It specifically covers the use of ISO 10993-1 but also is relevant to other biocompatibility standards (e.g., other parts of the ISO 10993 series of standards, ASTM, ICH, OECD, USP).  Topics covered in this guidance are:

  • Use of risk assessments for biocompatibility evaluations for a proposed medical device
  • Use of ISO 10993-1 and the FDA-modified matrix 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.”

It also contains valuable resources in the appendices such as: Device Master Files for Biocompatibility Evaluations, Summary Biocompatibility Documentation, Biocompatibility Evaluation Flow Chart, Content of a Biocompatibility Test Report and Component and Device Documentation Examples.

Download the guidance here.