GB/T 16886.3-1997
Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (English Version)

Standard No.

GB/T 16886.3-1997

Language

Chinese, Available in English version

Release Date

1997

Published By

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

Status

Be replaced 2008-09

Replace By

GB/T 16886.3-2008

Latest

GB/T 16886.3-2019

Scope

This standard specifies the following biochemical tests: - genotoxicity, - carcinogenicity, and - reproductive and developmental toxicity tests. The biological evaluation of certain types of medical devices involves these tests. GB/T 16886.1-ISO 10993-1 provides a guide for test selection. When it is confirmed that it is necessary to evaluate the potential genotoxicity, carcinogenicity and reproductive toxicity of medical devices and materials, the evaluation should be carried out according to this standard. Most of the tests in this standard refer to the provisions of the Organization for Economic Co-operation and Development (OECD) "Guidelines for Testing Chemical Drugs". During the test, it should be carried out according to the current OCCD "Guidelines for Chemical Drug Testing". Note 1: The term "device" is consistent with the definition given in GB/T 16886.1-ISO 10993.1, including materials, dental materials and devices. Definitions are in accordance with the European Committee for Standardization CEN standard documents.

GB/T 16886.3-1997 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 16886.3-1997 -All Parts