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ISO Publishes Testing Standard for Safety of Medical Devices

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

ISO
Wed, 10/06/2010 - 15:18
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(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.

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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.

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