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
8 Options for control measures for health software
products
9 Standards specific to risks of a particular nature
10 Observation on safety and risks in the user domain
11 Taxonomies
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