GB/T 16886.10-2017 Active National standards

GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization

Publish Date: 2017-12-29 Implement Date: 2018-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.10-2017

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2017-12-29

Implement Date: 2018-07-01

Pages: 60 pages

Scope

This part of GB/T 16886 describes the evaluation steps for potential irritation and skin sensitization of medical devices and their constituent materials. This part includes: a) considerations before irritation testing, including biosimulation experiments and in vitro methods for skin contact; b) detailed in vivo (irritation and sensitization) testing steps; c) key factors for result interpretation. Appendix A provides preparation instructions for specific materials related to the above-mentioned tests. Appendix B provides several special irritation tests applicable to medical devices other than the skin area.

Development Information

Word Count: 114 Thousand words Pages: 60 pages

Same series standard

GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Replace the following standards

GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity

Superseded by the following standards

GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization

Referenced Standards

GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process ISO 10993-2 ISO 10993-9 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-18 ISO 14155-1 ISO 14155-2