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.
BS PD CEN/TR 15640:2007 history
2007BS PD CEN/TR 15640:2007 Health informatics — Measures for ensuring the patient safety of health software