Relevant standards can be found at the following address
Standard number: YY/T 0664-2008, standard name: Medical device software software life cycle process
Standard Status: Current
English title: Medical device software - Software life cycle processes
Implementation date: 2009-6-1
Issuing authority: National Food and Drug Administration Administration
Content introduction: This standard adopts IEC 62034:2006 "Medical Device Software Life Cycle Process" (English version).
IEC 62034:2006 "Medical Device Software - Software Life Cycle Process" provides an index of terms defined in Chapter 3. This index will be deleted from this standard.
Clauses marked with an asterisk (*) in this standard indicate that there is guidance on that clause in Appendix B.
The terminology and Appendix C in IEC 62034:2006 "Medical Device Software Life Cycle Process" (English version) refer to the terms of ISO 14971:2000. Since the ISO 14971:2007 version has been released, the terms in this standard Reference the corresponding part of YY/T 0316-2008/ISO 14971:2007.
This standard specifies the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establish a common framework for the medical device software life cycle process.
This standard applies to the development and maintenance of medical device software.
This standard applies to the development and maintenance of medical device software when the software itself is a medical device, or when the software is an embedded part or component of the final medical device.
This standard does not cover the qualification and final release of a medical device, even when the medical device consists entirely of software.