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FDA Compliance

ISO Publishes Testing Standard for Safety of Medical Devices

ISO 10993-10:2010 tests for irritation and skin sensitization

Published: Wednesday, October 6, 2010 - 15:18

(ISO: Geneva) -- To ensure that medical devices do not irritate the skin or eyes, or cause other adverse reactions, the International Organization for Standardization (ISO) has published a testing standard for checking their safety prior to marketing and use.

ISO 10993-10:2010—“Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization,” describes procedures to assess medical devices and their constituent materials (including release of chemicals), so that they do not pose risks when in contact with human tissue.

Extra care has been taken to minimize the need for testing on animals, and ensure their well-being by encouraging the use of in vitro (not conducted in living beings) tests whenever possible.

“Traditionally, tests on small animals have been performed prior to testing on humans to help predict human response. More recent, in vitro tests as well as human tests have been added as adjuncts or alternatives. Despite progress and considerable effort in this direction, animal testing is still often required for reliable results and to ensure human safety. However, ISO 10993-10 now opens the possibility that in vitro tests take place prior to animal testing to identify risk. Furthermore, the standard aims to reduce the number of animals used, with a step-by-step approach, with review and analysis of test results at each stage,” explains Wim De Jong, project leader of the standard.

ISO 10993-10 requires that studies apply good laboratory practices and comply with regulations related to animal welfare. The standard is intended for use by trained professionals.

This third edition replaces the previous version published in 2002, which has since been technically revised.

ISO 10993-10—“Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization,” was developed by ISO/TC 194, “Biological evaluation of medical devices,” and is available from ISO national member institutes. For the complete list of members with contact details, visit www.iso.org/iso/about/iso_members.


About The Author

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The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.