标准编号：ISO/TR 80001-2-7:2015
中文名称：信息技术网络包含医疗器械的风险管理应用 第2-7部分：医疗保健服务组织（HDOs）自身如何符合IEC 80001-1 的指南
英文名称：Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their confor
发布日期：2015-04
标准范围
The purpose of this part of ISO/TR 80001 is to provide guidance to HDOs on self-assessment of theirconformance against IEC 80001-1.The purpose of this part of ISO/TR 80001 is toa) provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1,b) provide an exemplar assessment method which can be used by HDOs in varying contexts to assessthemselves against IEC 80001-1,c) define a PRM comprising a set of processes, described in terms of process purpose and outcomesthat demonstrate coverage of the requirements of IEC 80001-1, andd) define a PAM that meets the requirements of ISO/IEC 15504-2 and that supports the performance ofan assessment by providing indicators for guidance on the interpretation of the process purposes andoutcomes as defined in IEC 80001-1 (PRM) and the process attributes as defined in ISO/IEC 15504-2.This part of ISO/TR 80001 does not introduce any requirements in addition to those expressed inIEC 80001-1.
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