常规安全测试——温升、耐压、泄露电流、除颤防护测试、机械性测试、单一故障测试等。 电磁兼容测试——电源端子骚扰电压，辐射骚扰，谐波电流，电压波动和闪烁，静电放电抗扰度，射频辐射抗扰度，工频磁场抗扰度，电快速瞬变脉冲群抗扰度，射频传导抗扰度，浪涌抗扰度，电压暂降、短时中断和电压变化抗扰度。 产品特殊标准的测试——例如：血压精度、血氧精度、输液泵和输液控制器的精度测试等，以及监护，神经和肌肉刺激器等一系列产品的性能测试。
服务范围
适用产品范围
● 医用诊察和监护器械：多参数监护仪、心电图机、脉搏血氧仪、血压计、电子和红外体温计
● 呼吸、麻醉和急救器械：家用呼吸机、医用分子筛制氧机、家用分子筛制氧机、小型医用制氧机、便携式制氧机、医用氧气浓缩器、医用超声雾化器、医用压缩式雾化器、医用雾化器
● 物理治疗器械：神经和肌肉刺激器、低频电疗仪、中低频治疗仪、热垫式治疗仪、特定电磁波治疗仪、远红外辐射治疗仪、红外热辐射理疗灯、特定电磁波治疗器、电位治疗设备、红光治疗设备、紫外治疗设备
● 医疗器械消毒灭菌器械：医用清洗器、医用超声波清洗器注输、护理和防护器械：医用防护口罩、医用外科口罩、一次性使用医用口罩、日常防护型口罩、呼吸防护 自吸过滤式防颗粒物呼吸器、儿童口罩、针织口罩
● 患者承载器械：手动病床、电动病床
● 医用康复器械：助听器、手动轮椅车
● 临床检验设备：离心机、核酸提取仪、全自动核酸提取仪、全自动核酸纯化仪、全自动核酸提取纯化仪、医用冷藏箱、医用冷冻箱、医用冷藏冷冻箱、医用超低温冷冻箱、样品前处理系统、样品检查自动化系统、全自动样品处理系统、样品后处理系统、分杯处理系统、样本处理及孵育系统
● 医用软件：体外诊断类软件等
医疗器械测试标准
● 体外诊断类设备 / in vitro diagnostic medical devices
名称/Title | 国际标准/international standards | 国内标准/National standards |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment For Measurement, | IEC/EN 61010-1 | GB4793.1 |
测量、控制和试验室用电气设备的安全要求 Safety requirements for electrical equipment for measurement, control andlaboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101
| YY 0648 |
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 GB/T42125.14 |
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 |
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
名称 | 国际标准 | 国内标准 |
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 |
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 | |
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
| |
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 |
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 | GB 9706.26 |
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 | YY 9706.256 |
血压计 Non-invasive automated sphygmomanometers | ANSI/AAMI SP10 | YY 0670 |
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
| YY 9706.257 |
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 |
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 | GB9706.1 |
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 |
IEC/EN 60601-2-10
| YY 0607 |
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 |
| YY 0667 |
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 80601-2-49 | YY 0668 |
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 |
ISO / EN ISO 80601-2-61
| YY 0784 |
医用电气设备 第2-38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 |
心电诊断设备 Diagnostic electrocardiographic devices | ANSI/AAMI EC11 | YY 1139 |
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
| YY 9706.111 |
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 | |
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 |
红外体温计 infrared ear thermometers (with maximum device) | EN 12470-5 | GB/T 21417.1 |
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 | YY 0885 |
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 |
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 |
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 |
心电监护仪电缆和导联线 ECG trunk cables and patient leadwires | AAMI ANSI EC53 | YY 0828 |
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 |
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 safetyCollateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2
| YY 0505 YY9706.102 |
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 |
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 |
灯和灯系统的光生物安全性 Photobiological safety of lamps and lamp systems | IEC /EN62471 | GB/T 20145 |
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 |
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 |
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 |
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
| GB 9706.260 |
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 |
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
| YY/T 9706.106 |
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 of baby incubators |
IEC/EN 60601-2-19
| GB 9706.219 |
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
| |
医用电子体温计 Clinical electronic thermometer | GB/T21416 | |
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 |
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
| YY/T 0636.1 |
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 | IEC/EN 60601-2-37 | GB 9706.9 |
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment 医用超声诊断设备声输出公布要求
| IEC 61157 | GB/T16846 |
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 |
超声多普勒胎儿心率仪 ultrasonic Doppler fetal heartbeat detector | YY 0448 | |
超声多普勒胎儿监护仪 ultrasonic Doppler fetal monitor | YY/T0449 | |
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 |
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 |
医用内窥镜 | IEC/EN 60601-2-18 | YY 0068.1, YY 0068.2, YY/T 0068.3 ,YY 0068.4 |
医用胶囊式内窥镜 | YY 1298 | |
医用内窥镜照明用光缆 | YY/T 0763 | |
医用电子内窥镜 | YY 1587 | |
医用内窥镜 内窥镜功能供给装置 摄像系统 | YY/T1603 | |
环境试验要求及试验方法 | GB/T14710 | |
产品加速老化试验方法 | IEC62506 | GB/T34986 |
● 电池要求和部分家电产品检测标准 / Battery and household appliance testing standards
便携式和便携式装置用密封含碱性电解液二次电池的安全要求 Secondary cells and batteries containing alkaline or other non-acid electrolytes- Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable applications | IEC/EN 62133 | GB31241 |
联合国《关于危险货物运输的建议书 标准与试验手册》38.3 章 recommendations on the transportation of dangerous goods manual of tests and criteria | UN DOT 38.3 | |
家用和类似用途电器的安全 口腔卫生器具的特殊要求 Household and similar electrical appliances- Safety Particular requirements for for oral and hygiene appliances | IEC/EN60335-2-52 | GB 4706.59 |
家用和类似用途电器的安全加湿器的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for humidifiers | IEC/EN 60335-2-98 | GB 4706.48 |
家用和类似用途电器的安全按摩器具的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for massage appliances | IEC/EN 60335-2-32 |
GB 4706.10
|
家用和类似用途电器的安全 暖脚器和热脚垫的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for foot warmers and heating mats | IEC/EN60335-2-81 |
GB4706.80
|
家用和类似用途电器的安全紫外线和红外线辐射皮肤器具 的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for appliances for skin exposure to optical radiation |
IEC/EN 60335-2-27
|
GB4706.85
|
家用和类似用途电器的安全结合激光和强烈光源的美容和美容护理器具的特殊要求 Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources | IEC/EN60335-2-113 |
● 无线医疗的检测标准和法规要求 / Wireless Product testing standards
工作频段/Frequency | 测试标准 | 典型产品 Typical products | |
FCC | CE-RED | ||
2400MHZ-2483.5MHZ | FCC part 15 | EN300328 | 蓝牙，WLAN，ZIgBee等 |
LTD band 1/3/7/8/20/22/28/33/34/38/40/42/43 | 禁用Prohibited | EN301 983-13 | 利用LTE功能传输数据 Use LTE function to transfer data |
LTD band 2/4/5/7/12/13/17/41 | FCC part 22 | 禁用/Prohibited | 利用LTE功能传输数据 Use LTE function to transfer data |
868MHZ | 禁用Prohibited | EN300 220 | 用ASK、FSK类调制传输数据类Use ASK, FSK function to transfer data |
433.92MHZ | FCC part 15 | EN300 220 | 用ASK、FSK类调制传输数据类 Use ASK, FSK function to transfer data |
● 可靠性测试和失效分析 / Reliability and Failure mode analysis
| 测试类别及依据 | 测试项目 |
| 可 靠 性 Reliability IEC 60068,IEC60529,IE60598 EIA-364.MIL-STD-202, ISO 4892,ISO 1431, ASTM G 154,ASTM G155, ASTM D4728, etc. | 恒温恒湿Constant Temprature and Humidity |
| 振动Vibration | |
| 盐雾Salt Spray | |
| 温度湿度循环Temprature & Humidity Cycling | |
| 寿命分析Life Analysi | |
| 臭氧老化Ozone Aging | |
| 防水防尘Waterproof and Dustproof | |
| 震动&温度&湿度Vitration & Temprature & Humidity | |
| 高加速寿命试验HALT/HASS/HASA | |
| 失 效 分 析 与 预 防 Failure Analysis and Prevention IPC/ECAJ-STD,IPCTM 650-2 iS016232-10,etc. | PCB&PCBA失效分析和评估、PCB& PCBA Analysis and Evaluation |
| IC可靠性设计分析Reliability Design and Analysis of IC | |
| 无损检测Non-destructive Testing | |
| 涂镀层Coating and Palte Analysis | |
| 材料热学Material Thermal | |
| 材料硬度Materal Hardness | |
| 扫描电镜能谱分析SEM-EDS |
软件测评 / Software evaluation
● 软件测评服务主要包括：通用应用软件测评、APP安全检测、信息安全服务三个测评服务方向。
The software evaluation service includes general software evaluation, APP security test , information security.
● GB/T 25000.51-2016《系统与软件工程系统与软件质量要求和评价（SQuaRE）第51部分：就绪可用软件产品（RUSP）的质量要求和测试细则》 IEC/ISO25051
System and software engineering - System and software quality requirements and evaluation(SQuaRE)- part 51 requirements for quality of ready to use software software products( RUSP) and instructions for testing
● GB/T 25000.10-2016 《系统与软件工程系统与软件质量要求和评价（SQuaRE）第10部分：系统与软件质量模型 IEC/ISO25010
System and software engineering - System and software quality requirements and evaluation(SQuaRE)- part 10 System and software quality models
● 网络安全和漏洞评估
● YY/T1843-2022 医用电气系统及医疗器械软件的网络安全基本要求
IEC/TR80001-2-2 Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
相关标准
NF EN 50103:2003 EN 29001和EN 46001以及EN 29002和EN 46002在有源医疗器械行业(包括有源植入式器械)的应用指南
YY 0989.6-2016 手术植入物 有源植入医疗器械 第6部分:治疗快速性心律失常的有源植入医疗器械(包括植入式除颤器)的专用要求
DS/EN 45502-2-1:2004 有源植入式医疗器械 第 2-1 部分:用于治疗心动过缓的有源植入式医疗器械的特殊要求(心脏起搏器)
prEN 50103-1992 有源(包括有源可植入)医疗器械工业用
IS0 9001/EN 46001和IS0 9002/EN 46002应用导则
