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GB/T 16886.9-2017
GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
Abstract
This part of GB/T 16886 provides basic principles for the systematic evaluation of potential and observed biodegradation of medical devices, as well as the design and implementation of biodegradation studies. This part of GB/T 16886 does not apply to: a) the evaluation of degradation caused solely by mechanical processes; the methodology for generating such degradation products may be specified in specific product standards as appropriate.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Replaced |
| Standard Code | GB/T 16886.9-2017 |
| CCS | Medical devices |
| ICS | Medical equipment |
| Implement Date | 2018-07-01 |
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$ 47
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$ 47
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$ 47