首页> 外文期刊>International journal of occupational medicine and environmental health. >Evaluation of the safety of users of active implantable medical devices (AIMD) in the working environment in terms of exposure to electromagnetic fields – Practical approach to the requirements of European Directive 2013/35/EU
【24h】

Evaluation of the safety of users of active implantable medical devices (AIMD) in the working environment in terms of exposure to electromagnetic fields – Practical approach to the requirements of European Directive 2013/35/EU

机译:评估工作环境中有源植入式医疗设备(AIMD)使用者在电磁场中的安全性–符合欧洲指令2013/35 / EU的实用方法

获取原文

摘要

Objectives: Electromagnetic fields (EMF) may cause malfunctions in electronic devices, in particular in active implantable medical devices (AIMD), along with discomfort or health hazards to users. The use of AIMD by workers is increasing (especially cardiac pacemakers, implantable cardioverter defibrillators and wearable insulin infusion pumps). Electromagnetic fields may be much stronger in the working environment than applied in basic immunity tests of AIMD (based on EN 60601- 1-2:2015 and EN 50527-1:2016). European Directive 2013/35/EU regarding the safety of workers exposed to EMF considered the AIMD users to be “workers at particular risk” who need an individual evaluation of EMF hazards. The study aimed at evaluating the safety of users of AIMD in medical and industrial working environments exposed to EMF Material and Methods: Near the common sources of strong EMF applied in medical and industrial use, the “standard safety distances” (SSD) for AIMD users were evaluated (i.e., distances from the EMF source, where exposure drops below limits from Recommendation 1999/519/EC and AIMD safety may be expected). The analysis is based on the results of measurements of magnetic and electric field strengths near 127 typical devices, in their normal use. Results: The longest electric field related SSD was identified near dielectric sealers (up to 180 cm), and the longest magnetic field related SSD – near induction heaters (up to 450 cm). Conclusions: Electromagnetic fields related AIMD malfunctions need to be considered up to several meters from EMF sources. The “individual safety distance,” that is sufficient to ensure the safety of a particular AIMD user may be significantly different (usually shorter) from the presented SSD, but needs to be considered in the context of detailed safety data from the AIMD manufacturer (if available). The labelling indicating the location of the area of a strong EMF increases safety of AIMD users in the work environment.
机译:目标:电磁场(EMF)可能会导致电子设备,特别是有源植入式医疗设备(AIMD)发生故障,并给用户带来不适或健康危害。工人对AIMD的使用正在增加(尤其是心脏起搏器,植入式心脏复律除颤器和可穿戴式胰岛素输注泵)。在工作环境中,电磁场可能比AIMD的基本抗扰度测试(基于EN 60601-1-2:2015和EN 50527-1:2016)中所施加的磁场强得多。有关暴露于EMF的工人安全的欧洲指令2013/35 / EU认为AIMD用户是“有特殊风险的工人”,需要对EMF危害进行单独评估。该研究旨在评估AIMD在暴露于EMF的医疗和工业工作环境中的用户的安全性材料和方法:在医疗和工业用途中使用的常见强EMF的常见来源附近,AIMD用户的“标准安全距离”(SSD)进行了评估(即距EMF源的距离,在此情况下,暴露量降至低于1999/519 / EC建议书的限值,并且可以预期AIMD安全)。该分析基于在正常使用情况下对127种典型设备的磁场和电场强度的测量结果。结果:在电介质封口机附近(最长180厘米)确定了最长的电场相关SSD,在感应加热器附近(最长450厘米)确定了最长的磁场相关SSD。结论:与电磁场相关的AIMD故障需要考虑到距EMF源几米远的地方。足以确保特定AIMD用户安全的“个体安全距离”可能与所提供的SSD明显不同(通常更短),但需要结合AIMD制造商提供的详细安全数据加以考虑(如果可用)。指示强电动势区域位置的标签可提高AIMD用户在工作环境中的安全性。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号