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有源医疗器械检测注册

认证资质：
检测价格：电议
检测周期：7-15天
检测类型：标准检测
送样方式：不限

领域分类：医药-医疗器械

检测项目：医疗器械

服务地点：全国

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详细信息

服务背景

依据《医疗器械注册管理办法》（局令第16号）中的规定，第二类、第三类医疗器械由国家食品药品监督管理局会同国家质量监督检验检疫总局认可的医疗器械检测机构进行注册检测，医疗器械检测机构应当在国家食品药品监督管理局和国家质量监督检验检疫总局认可的检测范围内，依据生产企业申报适用的产品标准（包括适用的国家标准、行业标准或者生产企业制定的注册产品标准）对申报产品进行注册检测，并出具检测报告，方可用于临床试验或者申请注册。

注册检测作为医疗器械注册过程中重要的一环，其目的是为了验证医疗器械产品的性能要求及安全要求是否符合产品注册标准（或国家标准、行业标准）的规定，保证产品的有效性能和使用安全。只有通过了注册检测的产品，方可进行下一步的临床试验和最终的产品注册。

检测内容

CTI华测检测拥有CMA、CNAS资质，可以提供医疗器械有源产品测试、检验、认证、审核一站式解决方案，包括医用诊察和监护、急救、物理治疗、消毒灭菌、康复、临床检验设备等有源医疗器械安规、EMC、电磁兼容、可靠性、老化等有源医疗器械注册的安全性、有效性研究等一站式解决方案。

医疗器械有源产品测试

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,

Control ,and

Laboratory Use

IEC/EN 61010-1

GB4793.1

GB/T42125.1

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

andlaboratory use –Part 2-101: Particular requirements for in vitro diagnostic

(IVD) medicalequipm

IEC/EN 61010-2-101

YY 0648

GB/T42125.16

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 GB 9706.225
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 GB9706.227
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 GB9706.226
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 GB 9706.204
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
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 GB9706.210
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 YY 9706.230
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 YY 9706.249
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 YY 9706.261
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 YY 9706.252
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 ASTM E1112
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 ASTM E1965-98	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 ANSI/AAMI EC38:2007 AAMI/ANSI/ISO 60601-2-47:2012	YY 0885 YY 9706.247
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 GB9706.222
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 YY 9706.241
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 YY 9706.246
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 GB 9706.218
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 YY 9706.108
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 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2	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 ISO 27427	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 GB 9706.224
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 YY 9706.234
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 GB10152 GB9706.237
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 GB9706.7 GB9706.205
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

IEC62133-1

IEC62133-2

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

AS/NZS60335.2.52

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

AS/NZS 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

AS/NZS 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

AN/NZS 60335.2.81

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

AS/NZS60335.2.27

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
工作频段/Frequency	FCC	CE-RED	典型产品 Typical products
2400MHZ-2483.5MHZ	FCC part 15 FCC part 18	EN300328 EN301489-1/17 EN60950-1/EN62368-1 EN62479/EN62311	蓝牙，WLAN，ZIgBee等 Blue tooth, WLAN,Zigbee etc.
LTD band 1/3/7/8/20/22/28/33/34/38/40/42/43	禁用Prohibited	EN301 983-13 EN301 489-1/-52	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 FCC part 24 FCC part 27	禁用/Prohibited	利用LTE功能传输数据 Use LTE function to transfer data
868MHZ	禁用Prohibited	EN300 220 EN301 489-1/3 EN60950-1/EN62368 EN62479	用ASK、FSK类调制传输数据类Use ASK, FSK function to transfer data
433.92MHZ	FCC part 15 FCC part 18	EN300 220 EN301 489-1/3 EN60950-1/EN62368 EN62479	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