DD ISO/TS 25238:2007
Current
The latest, up-to-date edition.
Health informatics. Classification of safety risks from health software
Hardcopy , PDF
English
08-31-2007
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Principles of hazard and risk analysis
5 Assignment of a risk class to a health software product
5.1 Introduction
5.2 Assignment to consequence categories
5.3 Assignment of likelihood to consequences
5.4 Risk classes
5.5 Assignment of risk class to a health software product
5.6 Process of iteration
6 The analytical process
6.1 General
6.2 Involvement of stakeholders
6.3 Understanding the system and user environment
6.4 Consequence analysis
6.5 Likelihood analysis
6.6 Iteration
6.7 Reviews
6.8 Documentation
6.9 Incident library
7 Examples of assignment of risk classes to products
8 Relationship of risk classes to design and control of
production of products
Annex A (informative) Health software products and medical
devices: rationale
Annex B (informative) Examples of assignment of Risk Classes
Annex C (informative) Illustration of the nature of the relationship
between risk classes and potential controls
for risk management
Bibliography
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