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基本信息:
- 标准号:IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV EN-FR
- 标准名称:医学电气设备 第1-6部分:基本安全和基本性能的一般要求 补充标准:可用性
- 英文名称:Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 标准状态:现行
- 发布日期:2020-07-22
文档简介
IEC60601-1-6:2010+AMD1:2013+AMD2:2020CSVEN-FRMedicalelectricalequipment-Part1-6:Generalrequirementsforbasicsafetyandessentialperformance-Usabilityisacollateralstandardthatspecifiestherequirementsfortheusabilityofmedicalelectricalequipment.Itensuresthatequipmentisdesignedinawaythatiseasytouseandunderstandforpatients,healthcareprofessionals,andotherswhomayuseit.Thisincludesaspectssuchasclearlabeling,conspicuouswarnings,andsimplecontrols.
Thestandardalsospecifiestheimportanceofprovidinginformationtousersonhowtousetheequipmentsafelyandeffectively,includinganynecessarytraining.Thisinformationshouldbeprovidedinawaythatiseasytounderstandandfollow,andshouldnotbeoverlytechnicalorcomplex.
Additionally,thestandardspecifiestheneedforequipmenttobedesignedinawaythatensuresitsreliabilityanddurability,inordertominimizetheriskofmalfunctionorbreakdownduringuse.
Overall,IEC60601-1-6:2010+AMD1:2013+AMD2:2020CSVEN-FRMedicalelectricalequipment-Part1-6:Generalrequirementsforbasicsafetyandessentialperformance-Usabilityisacrucialstandardthatensuresthatmedicalelectricalequipmentiseasytouseandu
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