PD ISO/TR 27809:2007
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
08-31-2007
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
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