GB/T 16886.3-2008 Replaced National standards

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

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

Publish Date: 2008-01-22 Implement Date: 2008-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.3-2008

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2008-01-22

Implement Date: 2008-09-01

Pages: 17 pages

Scope

This part of GB/T 16886 specifies the following biological hazard identification strategies and tests for medical devices: — Genetic toxicity, — Carcinogenicity, and — Reproductive and developmental toxicity. This part of GB/T 16886 is applicable to the evaluation of medical devices identified as having potential genetic toxicity, carcinogenicity, or reproductive toxicity.

Development Information

Word Count: 30 Thousand words Pages: 17 pages

Replace the following standards

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

Superseded by the following standards

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

Referenced Standards

ISO 10993-18 OECD 414 OECD 415 OECD 416 OECD 421 OECD 451 OECD 453 OECD 471 OECD 473 OECD 476 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Adopt standards

ISO 10993-3:2003

Related Standards

YY/T 0456.1-2003 Replaced

YY/T 0456.1-2003 Regents for hematology analyzer use—Part 1:Rinse

Publish Date: 2003-06-20

YY/T 0456.2-2003 Replaced

YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin

Publish Date: 2003-06-20

YY/T 0456.3-2003 Replaced

YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent

Publish Date: 2003-06-20

YY/T 0475-2004 Replaced

YY/T 0475-2004 General technical requirements for urine analyzer

Publish Date: 2004-03-23

YY/T 0478-2004 Replaced

YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis

Publish Date: 2004-03-23

YY/T 0032-2004 Active

YY/T 0032-2004 Haemoglobin instrument

Publish Date: 2004-11-08