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GB/T 16886.3-2019 Active
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
Abstract
This part of GB/T 16886 specifies the risk assessment, the selection of tests for hazard (source) identification, and strategies for risk management, as well as the possibility of the following potentially irreversible biological effects caused by exposure to medical devices:
—— Genotoxicity;
—— Carcinogenicity;
—— Reproductive and developmental toxicity.
This part applies to the evaluation of medical devices that have been identified as having potential genotoxicity, carcinogenicity, or reproductive toxicity.
Note: Guidelines for test selection are provided in ISO 10993-1.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.3-2019 |
| CCS | Medical devices |
| ICS | Laboratory medicine |
| Implement Date | 2020-01-01 |
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