What is ISO 10993?
For nearly 10 years, Technical Committee 194 of the International Organization for Standardization (ISO) and its various working groups have been developing the documents known collectively as ISO 10993, a set of harmonized standards that address the biological evaluation of medical devices. During most of that period, the U.S. device industry has operated according to the Tripartite Guidance for medical device biocompatibility, which was introduced in 1987.
What is ISO 10993?
For nearly 10 years, Technical Committee 194 of the International Organization for Standardization (ISO) and its various working groups have been developing the documents known collectively as ISO 10993, a set of harmonized standards that address the biological evaluation of medical devices. During most of that period, the U.S. device industry has operated according to the Tripartite Guidance for medical device biocompatibility, which was introduced in 1987.
THE ISO 10993 STANDARDS
Technical Committee 194 meets annually in the spring to review progress made on the various 10993 standards and to chart a course for the coming year. Recent meetings were held in Stockholm in 1996 and in the UK city of York in 1997; the 1998 meeting will be held in the Washington, DC area. To date, 12 ISO 10993 standards have been issued by the committee:- 10993-1: “Guidance on Selection of Tests.”
- 10993-2: “Animal Welfare Requirements.”
- 10993-3: “Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity.”
- 10993-4: “Selection of Tests for Interactions with Blood.”
- 10993-5: “Tests for Cytotoxicity—In Vitro Methods.”
- 10993-6: “Tests for Local Effects after Implantation.”
- 10993-7: “Ethylene Oxide Sterilization Residuals.”
- 10993-8: No title assigned.
- 10993-9: “Degradation of Materials Related to Biological Testing.”
- 10993-10: “Tests for Irritation and Sensitization.”
- 10993-11: “Tests for Systemic Toxicity.”
- 10993-12: “Sample Preparation and Reference Materials.”
Summary

Article Name
Biological Evaluation of Medical Devices - ISO 10993
Description
Technical Committee 194 meets annually in the spring to review progress made on the various 10993 standards and to chart a course for the coming year. Recent meetings were held in Stockholm in 1996 and in the UK city of York in 1997; the 1998 meeting will be held in the Washington, DC area.
Author
William
Publisher Name
Pliance Inc.
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