IEC TR 80002-1-2009 下载积分: 1500 内容提示: IEC/TR 80002-1Edition 1.0 2009-09TECHNICAL REPORT Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software IEC/TR 80002-1:2009(E) colourinsideLICENSED TO MECON Limited. - RANCHI/BANGALORE,FOR ...
IEC TR 80002-1:2009 适用范围 “本技术报告为 ISO 14971:2007@ 医疗器械中包含的要求的应用提供指导?参考 IEC 62304:2006@ 医疗器械软件?将医疗器械风险管理应用于医疗器械软件?软件生命周期它不会添加@或以其他方式更改@ISO 14971:2007 或 IEC 62304:2006 的要求。本技术报告针对的是当软件包含在医疗设备/...
英文名称:Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 标准状态:现行 发布日期:2009-09-23 文档简介 IECTR80002-1:2009ENMedicaldevicesoftware-Part1:GuidanceontheapplicationofISO14971tomedicaldevicesoftware是一个针对医疗设备软件的标准,它提供了许多...
IEC/TR80002-1:2009ENMedicaldevicesoftware—Part1:GuidanceontheapplicationofISO14971tomedicaldevicesoftware是一个国际电气工程委员会(IEC)发布的医疗器械软件标准,它主要关注医疗器械软件的开发和应用。该标准分为多个部分,其中第一部分是关于ISO14971在医疗器械软件中的应用指南。
RISK MANAGEMENT REPORTVersion : RISK MANAGEMENT REPORTVersion :A/0 Appendix 2 List of Safety Characteristics of XXXXXX The list is based on the list of questions in Appendix B of the IEC TR 80002-1-2009. The intended use and safety-related characteristics of the medical device are judged. ...
The following questions are based on Appendix B of the IEC TR 80002-1-2009 B.1 Alarms and alerts: B1.1 Do specifications identify howthe SYSTEM reacts to multiplealarm conditions? B1.1.1 Are there multiple levels of alarms? Do higher level alarms override the audio for lower level alarms?
PD IEC/TR 80002-1:2009由英国标准学会 GB-BSI 发布于 2009-09-23。 PD IEC/TR 80002-1:2009 医疗设备软件 ISO 14971 在医疗器械软件中的应用指南的最新版本是哪一版? 最新版本是PD IEC/TR 80002-1:2009。 PD IEC/TR 80002-1:2009的历代版本如下: ...
PD IEC/TR 80002-1:2009 2007EN ISO 17510-1:2002EN ISO 18778-2005ISO/HL7 27931:2009IEC 62304-2006IEC/TR 80002-1-2009IEEE标准11073-00101-2008IEEE标准11073-10406-2011IEEE标准11073-10417-2011IEEE标准11073-10418-2011IEEE标准11073-10420-2010IEEE标准11073-10421-... 被引量: 0发表: 0年 Medical ...
IEC/TR 80002-1-2009 中文名称:医疗设备软件.第1部分:用于医疗设备软件的ISO 14971标准应用指南 英文名称:Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 中国标准分类(CCS):C37;C07 国际标准分类(ICS):11.040.01;35.080;35.240.80...
6) Does anyone know if IEC TR 80002-1:2009 is applicable to stand-alone software? I saw a post that seem to indicate it might only be applicable to when a software product needs to be verified at the user end (example hospital network) so I’m wondering if it would...