GB/T 16886.3-2008
Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (English Version)

Standard No.

GB/T 16886.3-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

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

Status

Be replaced 2020-01

Replace By

GB/T 16886.3-2019

Latest

GB/T 16886.3-2019

Replace

GB/T 16886.3-1997

Scope

This part of GB/T 16886 specifies strategies and tests for the identification of medical device hazards for the following biological aspects: — genotoxicity, carcinogenicity, and — reproductive and developmental toxicity. This part of GB/T 16886 applies to the evaluation of medical devices that are identified as having potential genotoxicity, carcinogenicity or reproductive toxicity.

GB/T 16886.3-2008 Referenced Document

• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements *， 2011-12-30 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update

GB/T 16886.3-2008 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 16886.3-2008 -All Parts