Health informatics. Classification of safety risks from health informatics products
Health informatics. Classification of safety risks from health informatics products
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What is DD CEN/TS 15260 - Classification of safety risks from health informatics products about?
DD CEN/TS 15260 is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. DD CEN/TS 15260 applies to hazards and risks which could cause harm to a patient. Other risks such as financial or organizational are out of scope unless they have the potential to harm a patient. Note 1: DD CEN/TS 15260 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. Note 2: DD CEN/TS 15260 does not apply to any software which is encompassed within EU Medical Devices Directives.
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