YY 9706.257-2021 医用电气设备第2-57部分：治疗、诊断、监测和整形医疗美容使用的非激光光源设备基本安全和基本性能的专用要求

ICS 01.040.01 C 40 YY 中华人民共和国医药行业标准 YY 9706.257—2021 医用电气设备 第2-57部分：治疗、诊断、 监测和整形/医疗美容使用的非激光光源 设备基本安全和基本性能的专用要求 Medical electrical equipment—Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011, MOD) 2021-03-09 发布 2023-05-01 实施 国家药品监督管理局 发布 YY 9706.257—2021 目 次 前言 ······························································································································································· Ⅲ 201.1 范围、目的和相关标准 ····························································································································· 1 201.2 规范性引用文件 ········································································································································· 2 201.3 术语和定义 ··············································································································································· 2 201.4 通用要求 ··················································································································································· 4 201.5 ME设备试验的通用要求 ··························································································································· 5 201.6 ME设备和ME系统的分类 ······················································································································· 5 201.7 ME设备标识、标记和文件 ······················································································································· 7 201.8 ME设备对电击危险的防护 ······················································································································· 10 201.9 ME设备和ME系统对机械危险的防护 ····································································································· 11 201.10 对不需要的或过量的辐射危险（源）的防护 ··························································································· 11 201.11 对超温和其他危险（源）的防护 ··············································································································· 12 201.12 控制器和仪表的准确性和危险输出的防护 ······························································································· 12 201.13 ME设备危险情况和故障状态 ··················································································································· 13 201.14 可编程医用电气系统（PEMS） ················································································································· 13 201.15 ME设备的结构 ········································································································································· 13 201.16 ME系统 ··················································································································································· 14 201.17 ME设备和ME系统的电磁兼容性 ············································································································· 14 附录A（资料性附录） 特定指南与原理 ··············································································································· 15 附录BB（资料性附录） 光辐射源 ······················································································································· 17 附录CC（资料性附录） LS设备的防护罩 ··········································································································· 21 附录DD（资料性附录） 制造商要求的概述 ··········································································································· 22 附录EE（资料性附录） 标记符号 ······················································································································· 23 参考文献 ····························································································································································· 24 图201.101 具有多个危险光源区域的设备说明标记示例 ······················································································· 9 图201.102 警告标签一览表符号 ··························································································································· 10 表201.101 LS设备风险等级的发射限值 ··············································································································· 6 表201.102 用于LS设备分类的风险等级时间基准 ··································································································· 7 表201.103 用于LS设备的可达发射评估的适用辐射角度 ······················································································· 7 表201.104 按照风险类别分类，LS设备的标记要求 ······························································································· 9 电 子 电 工 网 www.leike.com 免费下载 YY 9706.257—2021 附录L（资料性）光刺激的曝光范围 …… 17 附录M（规范性）ME设备或ME系统的光辐射 …… 18 附录P（资料性）ME设备或ME系统的风险管理 …… 20 附录Q（资料性）制造商要求的概述 …… 22 参考文献 …… 23 图 表 前言 …… 引言 ……