IEC-60601-1-6:2013 pdf download ​​​​​​​医用电气设备 - 第1-6部分:基本安全和基本性能的一般要求 - 附属标准:可用性 Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance Collateral standard:Usability

IEC-60601-1-6:2013 pdf download,Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance Collateral standard:Usability.
医用电气设备 - 第1-6部分:基本安全和基本性能的一般要求 - 附属标准:可用性
This International Standard specifies a PROCESS for a MANUFACTURER to analyse,specify,design,VERIFY and VALIDATE USABILITY,as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT,hereafter referred to as ME EQUIPMENT.
This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS,i.e.,NORMAL USE.It can be used toidentify but does not assess or mitigate RISKS associated with ABNORMAL USE.
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been compliedwith and the acceptance criteria documented in the USABILITY VALIDATION plan have been met(see 5.9 of IEC 62366:2007)，then the RESIDUAL RISKS,as defined in ISO 14971,associatedwith USABILITY of ME EQUIPMENT are presumed to be acceptable,unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
本国际标准规定了制造商分析、规定、设计、验证和确认可用性的过程，因为它与医疗电气设备(以下简称ME设备)的基本安全和基本性能有关。
此可用性工程过程评估并减轻由与正确使用和使用错误相关的可用性问题引起的风险。,正常使用。它可用于识别但不能评估或减轻与异常使用相关的风险。
如果本附带标准中详述的可用性工程过程已得到遵守，并且已满足可用性验证计划中记录的验收标准(见IEC 62366:2007中的5.9)，则假定ISO 14971中定义的与ME设备可用性相关的剩余风险是可接受的，除非有相反的客观证据(见IEC 62366:2007中的4.1.2)。