DD CEN/TS 15260-2006

标准号：DD CEN/TS 15260-2006
英文标准名称：Health informatics — Classification of safety risks from health informatics products —
标准类型：C07
发布日期：2006/7/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C07
国际标准分类号：35.240.80
适用范围：This document is concerned with the safety of patients and gives guidance on the analysis and categorisationof hazards and risks to patients from health informatics products, to allow any product to be assigned to one offive risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks such asfinancial 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 whetheror 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[7] [8] [9].