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Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization.

Biological evaluation of medical devices. Tests for skin sensitization.

Biological evaluation of medical devices - Tests for irritation and skin sensitization

1 Scope This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitizatio…