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医疗制药
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医疗器械有源产品测试
适用于有源医疗器械产品如医用诊察和监护、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;
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, 
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
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

FCC

CE-RED

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

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