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GB/T 16886.23-2023 Active
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
Abstract
This document specifies the evaluation steps for potential irritation of medical devices and their constituent materials, including the following: -- Considerations before irritation testing, including computer simulation tests and in vitro methods for skin contact; -- Detailed in vitro and in vivo irritation testing steps; -- Key factors for result interpretation. This document is applicable to predicting and classifying the potential irritation of medical devices, materials, or their extracts according to ISO 109931 and ISO 109932.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.23-2023 |
| CCS | Medical devices |
| Implement Date | 2024-12-01 |
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