Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Principles of hazard and risk analysis
6 Assignment of a risk class to a health informatics product
7 The analytical process
8 Examples of assignment of risk classes to products
9 Relationship of risk classes to design and control of
production of products
Annex A (informative) Health informatics 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