scope:

This document considers the control measures required to ensure patient safety in respect to health software products. 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. The document is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be regulated or controlled in some other formal or informal or voluntary manner whether national, regional or local. However it is not the purpose of this document to recommend whether or not health software products should be regulated. This document applies to any health software product whether or not it is placed on the market and whether or not it is for sale or free of charge. It is addressed to manufacturers of health software products.