YY/T 0456.1-2003
Replaced
GB/T 16886.5-2017
Active
National standards
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
Basic Information
Standard Code:
GB/T 16886.5-2017
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2017-12-29
Implement Date:
2018-07-01
Pages:
32 pages
Scope
This part of GB/T 16886 describes the test methods for evaluating the in vitro cytotoxicity of medical devices. This part specifies the incubation methods for direct contact with the device and/or device extracts, or contact with cultured cells through diffusion. This part is applicable to the in vitro determination of appropriate biological parameters for the biological response of mammalian cells.
Development Information
Same series standard
GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-12
Adopt standards
ISO 10993-5:2009
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active