国内外标准对应表
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标准号标准名称标准号标准名称
GB 9706.1-2007
(IEC
60601-1:1988+A1:1991+A2:1995,IDT) 医用电气设备第1部分：安全通用
要求
IEC 60601-1：2005 Medical electrical equipment -
Part 1: General requirements for
basic safety and essential
performance
GB 9706.15:-2008 (IEC 60601-1-1:2000,IDT) 医用电气设备第1-1部分：安全通用
要求并列标准：医用电气系统安全要
求
IEC 60601-1-1:2000 Medical electrical equipment -
Part 1-1: General requirements
for safety - Collateral
standard: Safety requirements
for medical electrical systems
YY 0505:2005
(IEC 60601-1-2:2001,IDT) 医用电气设备第1-2部分：安全通用
要求并列标准：电磁兼容要求和试验
IEC 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests
GB 9706.12-1997 (IEC 60601-1-3:1994,IDT) 医用电气设备第一部分：安全通用
要求三、并列标准：诊断X射线设
备辐射防护通用要求
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
YY/T 0708-2009 (IEC 60601-1-4:2000,IDT) 医用电气设备第1-4部分：安全通用
要求并列标准：可编程医用电气系统
IEC 60601-1-4：2000 Medical electrical equipment -
Part 1-4: General requirements
for safety - Collateral
Standard: Programmable
electrical medical systems
/ / IEC 60601-1-6:2010 Medical electrical equipment -
标准号标准名称标准号标准名称
Part 1-6: General requirements
for basic safety and essential
performance - Collateral
standard: Usability
YY 0709-2009
(IEC 60601-1-8:2001,IDT) 医用电气设备第1-8部分：安全通用
要求并列标准：通用要求，医用电气
设备和医用电气系统中报警系统的测
试和指南
IEC 60601-1-8:2006 Medical electrical equipment -
Part 1-8: General requirements
for basic safety and essential
performance - Collateral
Standard: General requirements,
tests and guidance for alarm
systems in medical electrical
equipment and medical electrical
systems
/ / IEC 60601-1-9:2007 Medical electrical equipment -
Part 1-9: General requirements
for basic safety and essential
performance - Collateral
Standard: Requirements for
environmentally conscious
design
/ / IEC 60601-1-10:2007 Medical electrical equipment -
Part 1-10: General requirements
for basic safety and essential
performance - Collateral
Standard: Requirements for the
development of physiologic
closed-loop controllers
/ / IEC 60601-1-11:2010 Medical electrical equipment -