GB/T 3533.1-1983
Replaced
YY/T 1473-2016
Replaced
Industry standards-Medicine
YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
Basic Information
Standard Code:
YY/T 1473-2016
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
General Principles of Standardization
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
21 pages
Scope
This standard provides guidance for standard writers on how to include safety requirements in the development of medical device safety standards. Medical device safety standards are expected to use the risk management framework established in ISO 14971. This guide includes safety-related performance and usability, and expands on the concepts developed in ISO/IEC Guide 51.
This standard is intended to be used in conjunction with ISO/IEC Guide 51 and ISO 14971.
Development Information
Superseded by the following standards
Adopt standards
ISO/IEC Guide 63:2012
Related Standards
GB/T 12366.1-1990
Replaced
GB/T 12366.1-1990 Guideline for the work of complex standardization—Principle and method
GB/T 12366.2-1990
Replaced
GB/T 12366.2-1990 Guideline for the work of complex standardization—General requirements of complex standardization for industrial products
GB/T 12366.3-1990
Replaced
GB/T 12366.3-1990 Guideline for the work of complex standardization—General requirements of complex standardization for agriculture products
GB/T 12366.4-1991
Replaced
GB/T 12366.4-1991 Guideline for the work of complex standardization—Drafting method for program of standard-complex
GB/T 12366.5-1991
Abolished