GB/T 16886.20-2015 Active
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
Abstract
This part of GB/T 16886 provides an immunotoxicology review of the potential immunotoxicity of medical devices. It also provides guidelines for testing the immunotoxicity of different types of medical devices. This part is based on several publications written by various immunotoxicology expert groups over the past few decades, and immunotoxicology is developing as an independent branch within the field of toxicology. Appendix A describes the current state of knowledge about immunotoxicity, and Appendix B provides an overview of the immunotoxicology clinical experience related to medical devices to date. Note: See Reference [11].
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.20-2015 |
| CCS | Medical devices |
| ICS | Laboratory medicine |
| Implement Date | 2017-01-01 |