PD ISO/TR 27809:2007

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Outline of the issues
5 General position on medical device controls
6 The border between health software products and medical
   devices
7 Classifying health software products
   7.1 Options
   7.2 Conclusions
8 Options for control measures for health software products
   8.1 Overview
   8.2 Labelling and documentation
   8.3 Clinical evidence
   8.4 Incident reporting
   8.5 Quality systems
   8.6 Design control
   8.7 Risk management
9 Standards relevant to risks of a particular nature
   9.1 General
   9.2 Conclusions
10 Observation on safety and risks in the user domain
   10.1 General
   10.2 Conclusions
11 Taxonomies
   11.1 General
   11.2 Conclusions
12 Summary of conclusions
Annex A (informative) Position regarding medical devices in
                      different countries
Annex B (informative) Analysis of classification procedures
Annex C (informative) Risk management
Bibliography

Describes the control measures required to ensure patient safety in respect to health software products.

This Technical Report 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 an accessory to a medical device or a medical device in its own right. This Technical Report 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 Technical Report to recommend whether or not health software products should be regulated. This Technical Report 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. AnnexA considers this matter in detail. This Technical Report 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.