GB/T 16886.20-2015 Active National standards

GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices

Publish Date: 2015-12-10 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.20-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2015-12-10

Implement Date: 2017-01-01

Pages: 18 pages

Scope

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].