ISO Issues New Device Standard to Test Skin, Eye Sensitivities

Sponsors should use a step approach to ensure their devices do not cause skin or eye irritations, according to a new standard by the International Organization for Standardization (ISO). Since no in vitro tests can unequivocally show a device will not cause a skin or eye irritation, in vivo animal tests are generally required prior to testing in humans, ISO 10993-10:2010 says. But to minimize the use of animals, devicemakers should, where appropriate, first use in vitro methods to help predict a human response before moving to animal testing.
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