GB/T 16886.3-2019 Active National standards

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

Publish Date: 2019-06-04 Implement Date: 2020-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 16886.3-2019

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2019-06-04

Implement Date: 2020-01-01

Pages: 31 pages

Scope

This part of GB/T 16886 specifies the risk assessment, the selection of tests for hazard (source) identification, and strategies for risk management, as well as the possibility of the following potentially irreversible biological effects caused by exposure to medical devices:
—— Genotoxicity;
—— Carcinogenicity;
—— Reproductive and developmental toxicity.
This part applies to the evaluation of medical devices that have been identified as having potential genotoxicity, carcinogenicity, or reproductive toxicity.
Note: Guidelines for test selection are provided in ISO 10993-1.

Development Information

Word Count: 58 Thousand words Pages: 31 pages

Replace the following standards

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

Referenced Standards

ISO 10993-1 ISO 10993-2 ISO 10993-6 ISO 10993-12 ISO 10993-18 OECD 414 OECD 415 OECD 416 OECD 421 OECD 451 OECD 453 OECD 471 OECD 473 OECD 476 OECD 487