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.
YY/T 0664-2008 Referenced Document
YY/T 0316 Medical devices.Application of risk management to medical devices*, 2016-01-26 Update
YY/T 0664-2008 history
2020YY/T 0664-2020 Medical device software software life cycle process
2008YY/T 0664-2008 Medical devices software.Software life cycle processes