医用X射线设备IEC 60601第3版系列标准研究初探

doi:10.3969/j.issn.1674-1633.2014.05.024

摘要
图/表
参考文献
相关文章 (8)

全文: PDF (1868 KB) HTML (1 KB)
输出: BibTeX | EndNote (RIS)

摘要自IEC 60601-1:2005 及其系列标准发布以来，由于其与第2版的标准理念和技术差异较大，在全世界医疗器械生产、检测及监管领域引起了巨大的震动。医用X射线设备的IEC60601第2版标准在我国执行经历了很长一段的时间，第3版的标准架构和技术参数与之有很多差异，本文就X射线设备两版标准的差异展开讨论。

	服务

	把本文推荐给朋友
	加入我的书架
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	侯耀芳

关键词 ：医用X射线设备, 设备安全, 通用标准, 专用标准

Abstract：The differences of the concepts and technologies between the 3^rd and 2^nd edition of IEC 60601-1:2005 standard had caused great controversy in medical devices manufacturing, testing and regulatory areas all over the world. This paper mainly discusses the differences of the two editions.

Key words： medical X-ray equipment equipment safety general standard particular standard

收稿日期: 2013-11-05

ZTFLH:

R814.41

引用本文:

侯耀芳. 医用X射线设备IEC 60601第3版系列标准研究初探[J]. 中国医疗设备, 2014, 29(5): 74-76.
HOU Yao-fang. Preliminary Study on IEC 60601-1 Standard 3rd Edition of Medical X-ray Equipment. China Medical Devices, 2014, 29(5): 74-76.

链接本文:

http://www.china-cmd.org/CN/10.3969/j.issn.1674-1633.2014.05.024 或 http://www.china-cmd.org/CN/Y2014/V29/I5/74

[2]	孙卓惠."标准"在医用电气设备符合性评价中的应用(下)[J].中国医疗设备,2010,25(7):154-156.
[4]	YY/T 0316-2008,医疗器械风险管理对医疗器械的应用[S].
[1]	刘群. IEC 60601系列标准的发布与发展情况[J].中国医疗器械杂志,2003,4(27):287-289.
[3]	杜堃,叶中琛.对IEC60601-1:2005标准引入风险管理过程后的讨论[J].中国医疗器械信息,2007,9(13):51-55.
[5]	IEC 60601-1:2005+A1:2012,Medical Electrical Equipment-Part 1:General requirements for basic safety and essential performance[S].
[6]	IEC 60601-2-63:2012,Medical electrical equipment-Part 2-63:Particular requirements for basic safety and essential performance of dental extra-oral X-ray equipment[S].
[7]	IEC 60601-2-65:2012,Medical electrical equipment-Part 2-65:Particular requirements for basic safety and essential performance of dental intra-oral X-ray equipment[S].
[9]	郑佳,张春青,余新华.IEC 60601-1第三版标准在我国转化及实施的初步探讨[J].中国医疗器械杂志,2011,4(35):284-285.
[8]	IEC 60601-1-3:2008,Medical electrical equipment-Part 1-3: General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment[S].