GB/T 16886.11-1997
Replaced
YY/T 0467-2016
Active
Industry standards-Medicine
YY/T 0467-2016 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY/T 0467-2016 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
Basic Information
Standard Code:
YY/T 0467-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
19 pages
Scope
This standard considers and identifies certain important standards and guidelines that are useful for assessing the compliance of medical devices with generally accepted basic principles of safety and performance.
This standard is intended to be used by manufacturers, standardization bodies, and regulatory authorities for compliance assessment.
Development Information
Replace the following standards
Adopt standards
ISO/TR 16142:2006
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