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IEC 60601-1-6-2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
适用范围：IEC 60601-1-6:2010 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. 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 to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with 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, associated with 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). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.
发布日期： 2010-01-27
实施日期： 2010-01-27
中标分类号： C37 - 医药、卫生、劳动保护 - 医疗设备通用要求
ICS分类号： 11.040.01 - 医药卫生技术 - 医疗设备综合
标准组织： IEC - 国际电工委员会标准
全文来源： WF
中文关键词： 事故预防 麻醉学 球压试验 防护等级 分类 间隙 色码 定义 设计 测定 尺寸 接地导线 接地 电气器具 电接触保护 电气外壳 (电网)电源 电力系统 电击 电气事故 电气工程 电气设备 医用电气设备 电气保护设备 电气安全 电驱动装置 电磁兼容性 电医学 静电学 外壳 环境条件 设备 设备安全 防爆 防火安全 适用性 图形符号 危害 冲击试验器 检验 使用说明书 绝缘外壳 绝缘材料 绝缘件 漏电路径 表 作标记 测量 测量技术 机械安全 医疗设备 医学放射学 医学科学 医疗技术学 职业安全 操作说明书 防电击 保护覆盖层 合格试验 辐射防护 危险分析 安全 安全装置 安全工程 安全规则 安全要求 规范(验收) 材料强度 调查 符号 温度 试验大气环境 试验设备 试验 试验条件 试验电压 变压器
英文关键词： EMC
语种： 汉语
页数： 51
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