DIN CEN/TS 15260-2007 医药卫生信息.健康信息产品防范风险分级

标准号：DIN CEN/TS 15260-2007
中文标准名称：医药卫生信息.健康信息产品防范风险分级
英文标准名称：Health informatics - Classification of safety risks from health informatics products; German and English version CEN/TS 15260:2006
标准类型：C07
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C07
适用范围：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 [7] [8] [9].