服务背景
超声诊断和监护设备的超声超温：超声诊断和监护设备的换能器组件不预期向患者提供热量，但由于换能组件内部的能量损耗和患者的超声吸收，产生了该问题。标准规定产品需同时满足2种试验条件的要求，即模拟使用和静止空气，用以避免换能器产生的超温导致的风险。模拟使用条件：根据换能器的预期用途，使用对应的体外/体内试验体模进行超温试验，验证其温度或温升符合标准要求。静止空气（无耦合剂）：将表面清洁的（无耦合剂）换能器组件悬挂在静止空气中，或将换能器组件的应用部分置于环境箱内空气流通最小的固定位置处，验证其温升符合标准要求。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
超声诊断和监护设备的超声能量：在一定条件下，通过热和机械方面的两种基本机理，超声可能引起改变或损害组织生物的效应。超声能量，即超声输出功率，影响着温升和空化的可能性，是临床应用关注的重要参数之一。利用超声功率计或水听器/声压平方空间积分法进行超声功率测量，可为制造商研发、用户安全使用超声产品提供可靠的数据参考。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
超声诊断和监护设备的超声能量：各种声输出参数（例如声强、声压、声功率等）在一定条件下，通过热和机械方面的两种基本机理，超声可能引起改变或损害组织生物的效应。温升和空化的可能性与总的能量输出、模式、超声波束的形状、焦点的位置、中心频率、波形的形状、帧率和工作持续系数有显著关系。机械指数（MI）和热指数（TI）的设计考虑了所有这些因素，是指导用户安全使用超声产品的重要参数。利用水听器和三维扫描系统测量医用超声设备在水中所产生的声场参数，可帮助制造商研发符合监管要求的超声设备，为用户安全使用超声产品提供可靠的数据支持。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
体温计实验室精度：体温计温度显示范围应不窄于标准规定的范围。在实验室参考条件下，对体温计在估算模式下按指定的测试步骤进行测量，并提取其读数。
在黑体设定以下的两个温度下重复试验：
记录体温计显示的温度读数，结果应符合显示范围的要求。体温计测量范围是保障体温计安全的重要试验之一，用来评价体温计的质量和电气安全特性。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
体温计实验室精度：体温计在宣称的温度显示范围内，最大允许误差达到标准要求。在实验室参考条件下，黑体温度应根据制造商的建议设定，对体温计按指定的测试步骤进行测量，并提取其读数。在测试前，体温计应在实验室参考条件下至少稳定30min，如果制造商另有规定，稳定时间可以更长。在宣称的温度显示范围内，黑体温度取间隔大致相同的三个温度点。若有需要，可适当增加测试点。体温计应在每个黑体温度下各测量3次，每次测试读数后都应更换新的一次性探测器保护罩(若有)。体温计实验室精度是保障体温计安全的重要试验之一，用来评价体温计的质量和电气安全特性。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
无创血压计的重复性：对于一个血压计，在静态连续低压状态下测量，在刻度范围内每一点重复测量的读数之间，相差应满足标准的要求 。
将设置当前的压力分别标准规定的压力点上, 观察在充气、放气过程中压力测量值与基准之间差值的变化，重复 10 次。
在每次试验中都将连续的管路压力调整到与基准所指示的同一压力水平。对于这 10 次压力试验中的每一次管路压力的设置，被测压力计的压力显示极差应在 标准要求的范围 之内。无创血压计的重复性是保障无创血压计安全的重要试验之一，用来评价无创血压计的质量和电气安全特性。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
无创血压计的重复性：无创血压计传感器精度：无论升压还是降压，在量程中的任何测量点上，袖带内压力测量的最大误差应达到标准的要求 。
用一个“Y”型三通与压力源和基准（已校准的压力计）相连，来验证压力转换／指示系统的准确性。无创血压计传感器精度是保障无创血压计安全的重要试验之一，用来评价无创血压计的质量和电气安全特性。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
服务背景
手术电极高频漏电流：手术附件及手术附件的电缆应有足够的绝缘，以减轻正常使用时对患者和操作者非预期热灼伤风险。应用于手术附件的绝缘，包括手术电极绝缘，但不包括手术连接器，应限制绝缘外表面上流通的高频漏电流小于对应类型的漏电流限值。手术电极高频漏电流是保障医疗电气产品安全的重要试验之一，用来评价医疗电气产品的质量和电气安全特性。
其医疗器械检测是医疗器械产品进入全球市场最基本的准入门槛。产品若出口到欧盟，美国，在满足欧盟，美国法规要求之前必须要有相对应的测试。
医疗器械其他服务内容
医疗器械测试标准
体外诊断类设备/ in vitro diagnostic medical devices
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
测量、控制和试验室用电气设备的安全要求第2-101部分：体外诊断(IVD)医用设备的专用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
测量、控制和实验室用电气设备的安全要求：实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
|
4 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
|
5 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
医用电器设备检测标准/Medical Device testing standards list
|
序号 |
名称 |
国际标准 |
国内标准 |
|
1 |
医用电气设备 第2部分 心电图机安全专用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
|
2 |
无创血压计第1部分:通用要求 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
EN ISO /ISO 81060-1 |
|
|
3 |
无创血压计.第3部分:电-机血压测量系统的补充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
医用电气设备 第1-1部分：通用安全要求 并列标准医用电气系统安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
医用电气设备 第2-27部分：心电监护安全及基本性能专用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27 |
GB 9706.25 |
|
7 |
医用电气设备 第2-26部分：脑电图机安全专用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
医用电气设备 第2-56部分:临床体温计的基本安全和性能的专用要求 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement |
ISO/ EN ISO 80601-2-56 |
|
|
9 |
血压计Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
医用电气设备--第2-57部分:治疗、诊断、监测和美容/美学使用的非激光光源设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
IEC/EN 60601-2-57 |
|
|
11 |
医用电气设备 第2-2部分:高频手术设备安全专用要求Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories |
IEC/EN/EN IEC 60601-2-2 |
GB 9706.4 |
|
12 |
医用电气设备第1部分：安全通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ANSI/AAMI ES60601-1 EN /IEC60601-1 |
GB9706.1 |
|
13 |
医用电气设备第2-10部分:神经和肌肉刺激器安全专用要求Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
医用电气设备 第2-30部分:自动循环无创血压监护设备的安全和基本性能专用要求Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC/EN 80601-2-30 |
YY 0667 |
|
15 |
医用电气设备 第2-49部分：多参数患者监护设备安全专用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
医用电气设备.医用脉搏血氧仪设备基本安全和主要性能专用要求Medical electrical equipment — Part 2-61: Particular requirements for basic safetyand essential performance of pulseoximeter equipment |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
医用电气设备 第2-38部分:医院电动床安全专用要求 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
医用电气设备 第2-51 部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心电诊断设备Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心电监护设备Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
医用电气设备 第1-11部分：安全及基本性能的通用要求—并列标准：家庭医疗保健环境下使用的医用电气设备和系统 Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
IEC/EN 60601-1-11 |
|
|
23 |
医用体温计.最大装置小型电体温计(非预测型和预测型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
临床体温计.连续测量用电子体温计的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
红外体温计 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC/EN 60601-2-47 AAMI/ANSI/ISO 60601-2-47:2012 |
YY 0885 |
|
27 |
医用电气设备 第2部分：诊断和治疗激光设备安全专用要求 Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment |
IEC/EN 60601-2-22 |
GB 9706.20 |
|
28 |
医用电气设备.第2部分:手术无影灯和诊断用照明灯安全专用要求 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC/EN 60601-2-41 |
YY 0627 |
|
29 |
医用电气设备 第2部分：手术台安全专用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
医用电气设备 第2-18部分:内窥镜设备安全专用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
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 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
医用电气设备 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列标准: 通用要求，医疗电气设备和医疗电气系中统报警系统的测试和指南 Medical electrical equipment- Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
IEC/EN 60601-1-8 |
YY0709 |
|
38 |
激光产品的安全 第1 部分:设备分类和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治疗设备,第1部分:雾化系统及其组成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
医用电气设备--第2-24部分:输液泵及控制器的基本安全和基本性能专用要求 Medical electrical equipment –Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC/EN 60601-2-24 |
GB 9706.27 |
|
42 |
医用电气设备--第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-34: Particular requirementsfor the basic safety and essential performance of invasive bloodpressure monitoring equipment |
IEC/EN 60601-2-34 |
YY0783 |
|
43 |
医用电气设备 2-60部分：牙科设备的基本安全和基本性能Medical electrical equipment –Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
IEC/EN 80601-2-60 |
|
|
44 |
医用设备 - 第一部分：医用设备可用性工程的应用 Medical devices IEC devices 62366-1: - Part 2015 1: IEC Application 62366: 2007+A1:2014 of usability engineering |
IEC/EN 62366-1 |
YY/T 1474 |
|
45 |
医用电气设备 - 第1-6部分：基本安全和基本性能的通用要求 - 并列标准：可用性 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral s tandard: Usability |
IEC/EN 60601-1-6 |
|
|
46 |
医用电气设备 第2部分:婴儿培养箱安全专用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19
|
GB 11243 |
|
47 |
医疗电气设备-第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance– Collateral Standard: Requirements for environmentally conscious design |
IEC/EN 60601-1-9 |
|
|
48 |
医用电子体温计 Clinical electronic thermometer |
|
GB/T21416 |
|
49 |
医疗器械软件 软件生存周期过程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
医用吸引设备 第1部分: 电动吸引设备 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
医用电气设备 第2-37部分：超声医疗诊断监视设备基本安全和基本性能的特殊要求 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
医用超声诊断设备声输出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
医疗诊断超声波设备的声输出报告用标准方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超声多普勒胎儿心率仪/ultrasonic Doppler fetal heartbeat detector |
|
YY 0448 |
|
55 |
超声多普勒胎儿监护仪ultrasonic Doppler fetal monitor |
|
YY/T0449 |
|
56 |
超声理疗设备 Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
IEC/EN 60601-2-5 |
YY/T1090 GB9706.7 |
|
57 |
超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
适用产品范围
医疗器械产品（包括：体温计，血氧仪，血压计，胎心仪，心电图机，彩超，X光机等）。
常规样品要求
完整能正常工作的样机，其他具体详情请咨询CTI在线客服。
我们的优势
常见问题
1.CTI的医疗器械检测的测试周期是多久？
实际周期根据委托的产品标准来确定，请与CTI客服联系确认。
2.CTI医疗器械检测的测试方法是什么？
针对产品的出口要以及客户委托的要求，进行标准检测。
3.CTI对于样品的留样周期是多久？
退样。
医疗电气设备的线性变压器绕组应有足够的绝缘以防止可能引起内部短路过热而导致的危险状况。变压器倍频倍压是保障医疗电气产品安全的重要试验之一，用来评价医疗电气产品的质量和电气安全特性。
医疗电气设备的变压器应对任何输出绕组短路或过载产生的过热进行保护。在变压器过载和短路状态下医疗电气设备依旧需要保持产品安全性，产品不会超温，绝缘不会失效。
指的是宣称防除颤的医疗电气设备在处于病人被除颤时，设备、患者电缆、电缆连接器等的任何未保护接地的可触及部分，不会因除颤电压的闪络释放出危险水平的电荷或能量；且在承受除颤电压后医疗电气设备应能继续行使其功能。
单一故障：指的是医疗设备只有一个降低风险的措施失效，或只出现一种非正常状态。在单一故障状态下医疗电气设备依旧需要保持产品安全性。
模压是保证医疗电气产品模压或注塑成形的热塑性材料外壳应构造得，由模压或注塑成形产生的内应力释放所引起材料的任何收缩或变形，不会导致不可接受的风险。模压测试是保障医疗电气产品安全的重要试验之一，用来评价医疗电气产品的外壳的安全特性。
球压是保证产品的绝缘材料的机械强度及耐热度是否能满足要求，以保证材料的绝缘特性不会降低。球压测试是保障医疗电气产品安全的重要试验之一，用来评价医疗电气产品的绝缘材料的安全特性。
在线咨询
粤公网安备 44030602000441号