GB/T 16886.20-2015
Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices (English Version)

Standard No.

GB/T 16886.20-2015

Language

Chinese, Available in English version

Release Date

2015

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 16886.20-2015

Scope

This part of GB/T 16886 gives an overview of immunotoxicology on the potential immunotoxicity of medical devices. This section also gives guidance on methods used to test the immunotoxicity of different types of medical devices. This section is based on several publications written over the past few decades by different expert groups in immunotoxicology, which has developed as a separate branch within the field of toxicology. The current state of knowledge regarding immunotoxicity is described in Appendix A, and an overview of clinical experience in immunotoxicology relevant to medical devices to date is given in Appendix B.

GB/T 16886.20-2015 Referenced Document

• GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
• GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
• GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
• GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
• GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
• YY/T 0316-2008 Medical devices.Application of risk management to medical devices

GB/T 16886.20-2015 history

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

GB/T 16886.20-2015 -All Parts