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Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Standard in brief
Scope of Application：
GB 9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。
本部分适用于医用电气设备和医用电气系统（以下简称ME设备和ME系统）。
Basic information
Standard No：GB 9706.228-2020
Standard Name：医用电气设备 第2-28部分：医用诊断X射线管组件的基本安全和基本性能专用要求
English Name：Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Standard Status：现行
Release Date：2020-12-24
Effective Date：2023-05-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.50
CCS Number：C43
Related Standards
Referenced Standards：GB/T 191,GB/T 1002,GB/T 1003,GB/T 2099.1,GB/T 2423.2-2008,GB/T 2439,GB/T 2941,GB/T 3667.1,GB/T 3768,GB/T 3785.1,GB/T 3785.2,GB 3836.1,GB/T 3836.5,GB/T 3836.6,GB/T 3836.7,GB/T 4026,GB/T 4074.6-2008,GB/T 4205,GB/T 4207,GB/T 4208,GB 4706.1-2005,GB 4943.1-2011,GB/T 5013.1-2008,GB/T 5023.1-2008,GB/T 5169.16,GB/T 5465.2,GB/T 6346.14-2015,GB 7247.1-2012,GB 8897.4,GB 8898-2011,GB/T 9364.1,GB 9706.12,GB/T 11021,GB/T 11210,GB/T 11918.1,GB/T 11918.2,GB/T 14790.1,GB/T 15092.1,GB/T 16886(所有部分),GB/T 16895.21,GB/T 16935.1-2008,GB/T 17465.1,GB 18278.1,GB 18279.1-2015,GB 18280.1-2015,GB/T 19212.2,GB/T 23821-2009,GB 27701,GB/T 28164,YY/T 0316-2016,YY/T 0466.1,YY 0505,YY/T 0664-2008,YY 0709,ISO 2882,ISO 3864-1:2002,ISO 7000:2004,ISO 7010:2011,ISO 9614-1,ISO 80000-1:2009,IEC 60601-1-6,IEC 60730-1:2010,IEC 60851-3:2009,IEC 60851-5:2008,GB 9706.103-2020,GB/T 5465.2-2008,YY/T 0062,YY/T 0063,YY/T 0064-2016,IEC/TR 60788:2004
Adopted Standards：IEC 60601-2-28:2017
Adopted Standard Name：《医用电气设备 第2-28部分:医用诊断X射线管组件的基本安全和基本性能专用要求》
Adoption Level：MOD
Publication Information
Number of pages：24
Number of words：38 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2020-12-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家市场监督管理总局、国家标准化管理委员会
Standard Type：CN
Standard Attribute：GB
Other Standard Number：9706.228
Management Organization：国家药品监督管理局
Proposing Department：国家药品监督管理局
