DD CEN/TS 15260:2006

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

Pertains to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient.

This Technical Specification is concerned with the safety of patients and gives guidance on the analysis and categorisation of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient. This Technical Specification applies to any health informatics product whether or not it is placed on the market and whether or not it is for sale or free of charge. Examples of the application of the classification scheme are given. This Technical Specification does not apply to any software which is encompassed within EU Medical Devices Directives [7] [8] [9].