医疗卫生装备2023,Vol.44Issue(11) :79-82.DOI:10.19745/j.1003-8868.2023233

GB 9706.255-2022标准修订要点解析

Key points analysis for GB 9706.255-2022 revision

马小建 王伟 张巍 胡知诿
医疗卫生装备2023,Vol.44Issue(11) :79-82.DOI:10.19745/j.1003-8868.2023233

GB 9706.255-2022标准修订要点解析

Key points analysis for GB 9706.255-2022 revision

马小建 1王伟 2张巍 1胡知诿1
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作者信息

  • 1. 深圳迈瑞生物医疗电子股份有限公司,广东深圳 518057
  • 2. 上海市医疗器械检验研究院,上海 201318
  • 折叠

摘要

介绍了 GB 9706.255-2022《医用电气设备第2-55部分:呼吸气体监护仪的基本安全和基本性能专用要求》修订的背景及范围,从整体上对比了 GB 9706.255-2022和YY 0601-2009《医用电气设备呼吸气体监护仪的基本安全和主要性能专用要求》的差异,并对基本性能、标识标记和文件、防护等级、校准/校零、粗鲁搬运、功能性连接、可用性等具体修订要点进行了解读可为生产企业和检验技术人员正确理解标准提供参考.

Abstract

The background and scope of the revision of GB 9706.255-2022"Medical Electrical Equipment-Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors"were introduced.The differences between GB 9706.255-2022 and YY 0601-2009"Medical electrical equipment particular requirements for basic safety and essential performance of respiratory gas monitors"were summarized.The key points of the revision of GB 9706.255-2022 were interpreted in terms of basic performance,marking signs and documents,protection level,calibration/nulling,rough handling,functional connectivity and usability.References were provided for manufacturers and inspection technicians to correctly understand GB 9706.255-2022.[Chinese Medical Equipment Journal,2023,44(11):79-82]

关键词

GB/9706.255-2022/YY/0601-2009/标准修订/医用电气设备/呼吸气体监护仪

Key words

GB 9706.255-2022/YY 0601-2009/standard revision/medical electrical equipment/respiratory gas monitor

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出版年

2023
医疗卫生装备
军事医学科学院卫生装备研究所

医疗卫生装备

CSTPCD
影响因子:0.776
ISSN:1003-8868
参考文献量3
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