Health informatics. Classification of safety risks from health software1 Scope This Technical Specification is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health software products, in order 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 organizational risks, are outside the scope of this Technical Specification unless

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including volume

focusing mainly on noise source localization

Those used by laypersons and/or healthcare professionals

— oxygen-enriched air

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It is necessary in these cases to inspect the relevant spectral regions

The maximum measurable dose in the pulse

characterised from 1 MHz up to 250 MHz

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