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: 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.
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Sisällysluettelo
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 Position regarding medical devices in different countries (informative)
Annex B Analysis of classification procedures (informative)