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1、超声诊断设备适用 SFDA 标准法规标准编号标准名称GB 9706.1-2007；IEC 60601-1+A1:1991+A2:1995医用电气设备 第 1 部分：安全通用要求；符合性标准强制通用安全GB 10152-2009B 型超声诊断设备；符合性标准强制电气专用安全GB 9706.9-2008医用超声诊断和监护设备专用安全要求符合性标准强制电磁兼容YY 0505-2005；IEC 60601-1-2:2001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 要求和试验符合性标准-参考环境GB/T 14710-1993医用电气设备 环境要求及试验方法符合性标准强制风险管理Y
2、Y/T 0316-2008；ISO 14971:2007医疗器械 风险管理对医疗器械的应用符合性标准强制生物学评估GB/T 16886.1-2001 ；ISO 10993-1:1997医疗器械生物学评价 第 1 部分：评价与试验符合性标准强制GB/T 191-2008；ISO 780:1997包装储运图示标志符合性标准强制GB 9969.1-1998工业产品使用说明书 总则符合性标准强制标识、随机文件YY 0466-2003；ISO 15223:2000用于医疗器械标签、标记和提供信息的符号符合性标准强制包装GB/T 15464-1995仪器仪表包装通用技术条件符合性标准参考声输出GB/T16
3、846-2008 ；IEC 1157:1992医用超声诊断设备声输出公布要求符合性标准强制JJG 639-1998医用超声诊断仪超声源检定规程符合性标准强制其它专用标准YY 0593-2005超声经颅多普勒血流分析仪符合性标准强制临床试验国内法规国家食品药品监督管理局令 5 号医疗器械临床试验规定符合性法规强制标识要求国内法规国家食品药品监督管理局令 10 号医疗器械说明书、标签和包装标识管理规定符合性法规强制医疗器械适用 CE 标准法规 1标准编号标准名称EN 60601-1电气通用安全要求Medical electrical equipment - Part 1: General requ
4、irements for safety （1990+A1: 1993+A2: 1995+A13: 1996）通用安全EN 60601-1-1:2001电气系统安全要求Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems电气安全专用EN 60601-2-37超声设备专用安全要求Medical electrical equipment - Part 2-37:
5、Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment（2001+A1: 2005+A2: 2005）电磁兼容EN 60601-1-2:2007EMC 标准Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and testsEN
6、ISO 14971:2007风险管理标准Medical devices - Application of risk management to medical devices风险管理EN 60601-1-41996+A1:1999软件风险管理Medical electrical equipment - Part 1-4: General requirements for safety; Collateral standard: Programmable electrical medical systems生物学评估EN ISO 10993-1:2003生物兼容性评估标准Biological e
7、valuation of medical devicesPart 1: Evaluation and testingEN 980:2008标识要求Symbols for use in the labelling of medical devicesEN 1041:1998标识要求Terminology, Symbols and information provided with Medical Devices: information supplied by the manufacturer with medical devicesIEC 60878：2003标识符号要求Graphical s
8、ymbols for electrical equipment in medical practice标识、随机文件ISO 1000：1992+Amendment1:1998国际单位要求SI units and recommendations for the use of their multiples and of certain other units声输出EN 61157：2007声输出公布要求Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
9、可用性EN 60601-1-6：2007可用性要求Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability软件生命周期EN 62304：2006软件生命周期过程Medical device software Software life cycle processes医疗器械适用 CE 标准法规 2标准编号标准名称93/42/EEC：1993医疗器械指令COUNCIL DIRECTIVE 93/42/EEC Of 14 June 1993 co
10、ncerning medical devices+M1: Directive 98/79/EC+M2: Directive 2000/70/EC+M3: Directive 2001/104/EC+M4: Regulation No 1882/20032006/95/EC：2006低电压指令Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonization of the laws of Member States relating to elect
11、rical equipment designed for use within certain voltage limits法规2004/108/EC：2004电磁兼容指令Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336
12、/EEC医疗器械适用 FDA/CMDL 标准法规标准编号标准名称UL 60601-1：2003UL 医用电气安全通用要求Medical Electrical Equipment Part 1: General Requirements for Safety 通用安全CAN/CSA-C22.2 No.601.1-B90加拿大医用电气安全通用要求Medical Electrical Equipment Part 1: General Requirements for Safety （M90+ supplement 1: 1994+A2: 1998）UD 2：2004超声设备声输出测试标准ACOUS
13、TIC OUTPUT MEASUREMENT STANDARD FOR DIAGNOSTIC ULTRASOUND EQUIPMENT声输出UD 3：2004超声设备热指数和机械指数实时显示标准STANDARD FOR REAL-TIME DISPLAY OF THERMAL AND MECHANICAL ACOUSTIC OUTPUT INDICES ON DIAGNOSTIC ULTRASOUND EQUIPMENT超声诊断设备 FDA 认证专用指南September 9, 2008：Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers法规指南超声诊断设备加拿大认证专用指南2005/07/06：Device Licence Applications forUltrasound Diagnostic Systemsand Transducers
