ISO/PRF TS 29321

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 any health software product whether or not it is placed on the market as an off the shelf or configurable product and whether or not it is for sale or free of charge. It is addressed to all manufacturers of health software products as defined in this document.