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Normas DIN – AENOR
DIN CEN/TS 15260:2007-04

DIN CEN/TS 15260:2007-04

Health informatics - Classification of safety risks from health informatics products; German and English version CEN/TS 15260:2006

Informatique de santé - Classification des risques de sûreté des produits d'information de santé; Version allemande et anglaise CEN/TS 15260:2006

Medizinische Informatik - Klassifikation von Sicherheitsrisiken bei der Benutzung von Medizininformatikprodukten; Deutsche und Englische Fassung CEN/TS 15260:2006

Fecha Anulación:
2018-07 /Withdrawn
Equivalencias internacionales:

CEN/TS 15260 (2006-03)

Resumen:
This document 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 document 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 document does not apply to any software which is encompassed within EU Medical Devices Directives.
Keywords:
Analysis, Categories, Classification, Classification systems, Computer sciences, Computer software, Damage, Definitions, Hazard analysis, Hazard classes, Hazards, Health protection, Medical devices, Medical informatics, Medical products, Medical sciences, Multilingual, Patient protection, Patients, Public health, Risk, Risk analysis, Safety, Software
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