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GB/T 16886.10-2024 Active
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
Abstract
This document specifies the evaluation steps for potential skin sensitization reactions induced by medical devices and their constituent materials.
This document is applicable to:
—— Detailed in vivo skin sensitization test steps;
—— Key factors for interpreting the results.
Note: Preparation instructions for specific materials related to the aforementioned tests are provided in Appendix A.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.10-2024 |
| CCS | Medical devices |
| Implement Date | 2025-09-01 |
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