DS/EN 80001-1-2011

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

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标准号

DS/EN 80001-1-2011

发布日期

2011年04月14日

实施日期

2011年04月14日

废止日期

无

国际标准分类号

11.040.01;35.240.80

发布单位

DK-DS

适用范围

Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirablebenefits (for example, INTEROPERABILITY), this international standard defines the roles,responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKSincorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEMSECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISKlevels.NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971 [4]. Therelationship between ISO 14971 and this standard is described in Annex A.This standard applies after a MEDICAL DEVIC