GB/T 16886.11-1997
Replaced
YY/T 0870.6-2019
Active
Industry standards-Medicine
YY/T 0870.6-2019 Test for genotoxicity of medical devices—Part 6:In vitro mammalian cell micronucleus test
YY/T 0870.6-2019 Test for genotoxicity of medical devices—Part 6:In vitro mammalian cell micronucleus test
Price:
$ 51
Basic Information
Standard Code:
YY/T 0870.6-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2019-07-24
Implement Date:
2020-08-01
Pages:
16 pages
Scope
This part of YY/T 0870 specifies the method for in vitro micronucleus test of mammalian cells for medical devices/materials. This part is applicable to determining the number of micronuclei in mammalian cells produced by medical devices/materials in vitro, and screening whether medical devices/materials have potential genotoxic effects. Note: The relevant tests for nanomaterials can be carried out in accordance with this part.
Development Information
Same series standard
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 16886.3-1997 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
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