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CEN/TS 15260:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Health informatics - Classification of safety risks from health informatics products
16-11-2017
29-03-2006
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
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