Health Informatics — Application of clinical risk management to the manufacture of health software
ISO/TS 29321:2008 describes the risk management processes required to ensure patient safety in respect to the manufacture of health software products as defined in this document. It does not apply to software which is:
necessary for the proper application of a medical device or
which is an accessory to a medical device or
which is a medical device in its own right.
ISO/TS 29321:2008 applies to…