GB/T 16886.3-2019
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (English Version)

Standard No.

GB/T 16886.3-2019

Language

Chinese, Available in English version

Release Date

2019

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 16886.3-2019

Replace

GB/T 16886.3-2008

Scope

This part of GB/T 16886 specifies risk estimation, selection of hazard (source) identification tests and risk management strategies, as well as the possibility of the following potentially irreversible biological effects due to exposure to medical devices: 　——Genotoxicity; 　——Carcinogenicity; 　——Reproductive and developmental toxicity. This section applies to the evaluation of medical devices that have been determined to have potential genotoxicity, carcinogenicity, or reproductive toxicity. Note: Guidelines for test selection are given in ISO10993-1.

GB/T 16886.3-2019 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

GB/T 16886.3-2019 history

• 2019 GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• 2008 GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• 1997 GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.3-2019 -All Parts