S.R. CEN TR 15640:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Hardcopy , PDF
08-12-2017
English
01-01-2007
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
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
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