YY/T 0456.1-2003
Replaced
GB/T 16886.11-2021
Active
National standards
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Price:
$ 102
Basic Information
Standard Code:
GB/T 16886.11-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2021-11-26
Implement Date:
2022-12-01
Pages:
33 pages
Scope
This document specifies the requirements for evaluating potential adverse systemic reactions caused by medical device materials, and provides guidelines for experimental procedures.
This document is applicable to the systemic toxicity studies of medical devices or materials.
Development Information
Same series standard
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
Adopt standards
ISO 10993-11:2017
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