DANSK DS/CEN/TR 15640 PDF

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. NOTE – The scope is intended to cover health software products which are not, in practice, covered by medical device regulations. Annex A considers this matter in detail. This TR acknowledges that, on the boundary, there are health software products which are encompassed by medical device regulations in some countries but not in others and that some definitions of medical devices may appear to cover health software products in general but in practice do not.