BS EN 50527-2-1-2011 工作轴承有源植入性医疗器械的电磁场辐射暴露的评定规程.对佩戴心脏起搏器工作者的具体评估

标准号：BS EN 50527-2-1-2011
中文标准名称：工作轴承有源植入性医疗器械的电磁场辐射暴露的评定规程.对佩戴心脏起搏器工作者的具体评估
英文标准名称：Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers
标准类型：A58
发布日期：2011/7/31 12:00:00
实施日期：2011/7/31 12:00:00
中国标准分类号：A58
国际标准分类号：11.040.40;13.280;17.240
引用标准：EN 50527-1-2010;EN 45502-2-1-2003;EN 62226-3-1-2007
适用范围：This European Standard provides the procedure for the specific assessment required in Annex A ofEN 50527-1:2010 for workers with implanted pacemakers. It offers different approaches for doing the riskassessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, theyhave to be assessed separately.The purpose of the specific assessment is to determine the risk for workers with implanted pacemakersarising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood ofclinically significant effects and takes account of both transient and long-term exposure within specific areasof the workplace.NOTE 1 This standard does not address risks to workers bearing a pacemaker from contact currents.The techniques described in the different approaches may also be used for the assessment of publiclyaccessible areas.The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with thepacemaker occurs when the exposure limits are not exceeded.NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in Clause 5 of ANSI/AAMI PC69:2007.