GB/T 16886.11-1997
Replaced
YY/T 0870.7-2023
Active
Industry standards-Medicine
YY/T 0870.7-2023 Test for genotoxicity of medical devices—Part 7:In vivo mammalian alkaline comet assay
YY/T 0870.7-2023 Test for genotoxicity of medical devices—Part 7:In vivo mammalian alkaline comet assay
Price:
$ 36
Basic Information
Standard Code:
YY/T 0870.7-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-01-13
Implement Date:
2024-01-15
Pages:
12 pages
Scope
This document specifies the method of the alkaline comet assay in mammals for the genetic toxicity testing of medical devices/materials.
This document is applicable to screening whether medical devices/materials have potential genetic toxicity by measuring the breaks in the nuclear DNA chains of mammals caused by medical devices/materials.
Note: When conducting the alkaline comet assay in mammals on nanomaterials and cross-linking agents, specific modifications to the methods in this document may be required, but these modifications are not described in this document.
Development Information
Referenced Standards
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 16886.3-1997 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
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
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
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced