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GB/T 16886.16-2021 Active
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
Abstract
This document stipulates the principles of designing and conducting pharmacokinetic studies related to medical devices. Appendix A describes the issues to be considered in pharmacokinetic studies during the biological evaluation of medical devices. This document applies to pharmacokinetic studies of degradation products and leachables in medical devices.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.16-2021 |
| CCS | Medical devices |
| ICS | Laboratory medicine |
| Implement Date | 2022-12-01 |
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