GB 9706.8-1995
Replaced
YY/T 0664-2008
Replaced
Industry standards-Medicine
YY/T 0664-2008 Medical device software—Software life cycle processes
YY/T 0664-2008 Medical device software—Software life cycle processes
Basic Information
Standard Code:
YY/T 0664-2008
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Medical equipment
Publish Date:
2008-04-25
Implement Date:
2009-06-01
Pages:
59 pages
Scope
This standard specifies the requirements for the life cycle of medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for the life cycle process of medical device software.
Development Information
Superseded by the following standards
Referenced Standards
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
Adopt standards
IEC 62304:2006
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced