GB/T 16886.10-2017
AbolishedBiological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
Application Summary AI generated
This standard specifies test methods for evaluating the potential of medical devices to cause skin irritation and allergic contact sensitization. It is applied during the biological safety assessment of materials and finished devices that come into direct or indirect contact with human skin, such as surgical gloves, wound dressings, and implantable components. The testing ensures compliance with regulatory requirements for clinical use and manufacturing quality control.
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