PD CEN/TR 15640:2007

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Symbols and abbreviations
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 General
   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 specific to risks of a particular nature
   9.1 Conclusions
10 Observation on safety and risks in the user domain
   10.1 Conclusions
11 Taxonomies
   11.1 Conclusions
12 Summary of conclusions
Annex A (informative) Position regarding medical devices in
        different countries
      A.1 The EU, Australia and Canada
      A.2 USA
      A.3 The Global Harmonization Task Force (GHTF)
Annex B (informative) Analysis of classification procedures
      B.1 EU, Australian, Canadian and GHTF Medical Device
          Classification
      B.2 USA Medical Device Classification
      B.3 USA FDA guidance related to software classification
      B.4 CEN classification of health software products
      B.5 Conclusions
Annex C (informative) Risk management
      C.1 Attributes necessary for successful uptake of risk
          management processes
      C.2 Minimum components for an effective risk management
          process
      C.3 'Enterprise risk management' processes
      C.4 'Healthcare related' risk management standards
      C.5 Related risk management standards
      C.6 Overall conclusions regarding risk management standards
Bibliography

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

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.