其医疗器械检测是医疗器械产品进入全球市场*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
有源器械安全测试 Testing of active medical device
电磁兼容测试与整改服务 EMC testing and debugging service
可靠性测试 Reliability Testing
NMPA注册与备案检测服务NMPA registration testing service
有效期寿命验证Validation of product life
失效分析Failure mode analysis
生物兼容性测试 biocompatibilitytest
软件测评Software evaluation
全球市场准入；Global marketing access
美国代理人服务（US Agent）；US agent service
欧盟代理人服务 EU representative service
培训服务Training Service
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 医用电气设备 第2-52部分:医院电动床安全专用要求 Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds | 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.*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 ANSI/AAMI EC38:2007 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 - **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）。
以上文章内容为部分列举，更多检测需求及详情免费咨询机构在线顾问：15201733840(电话及微信)，做检测上百检网-出具权威检测报告具有法律效力。
