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GB/T 16886.10-2017 Active
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
Abstract
This part of GB/T 16886 describes the evaluation steps for potential irritation and skin sensitization of medical devices and their constituent materials. This part includes: a) considerations before irritation testing, including biosimulation experiments and in vitro methods for skin contact; b) detailed in vivo (irritation and sensitization) testing steps; c) key factors for result interpretation. Appendix A provides preparation instructions for specific materials related to the above-mentioned tests. Appendix B provides several special irritation tests applicable to medical devices other than the skin area.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.10-2017 |
| CCS | Medical devices |
| ICS | Laboratory medicine |
| Implement Date | 2018-07-01 |
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$ 123
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$ 123
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Order Total (incl. tax)
$ 123