我們的服務(wù)

作為中國(guó)第三方檢測(cè)與認(rèn)證服務(wù)的開(kāi)拓者和領(lǐng)先者,CTI華測(cè)檢測(cè)為全球客戶提供一站式檢驗(yàn)、測(cè)試、校準(zhǔn)、認(rèn)證及技術(shù)服務(wù)。

行業(yè)解決方案

服務(wù)能力已全面覆蓋到紡織服裝及鞋包、嬰童玩具及家居生活、電子電器、醫(yī)學(xué)健康、食品及農(nóng)產(chǎn)品……等行業(yè)的供應(yīng)鏈上下游。

特色服務(wù)

全面保障品質(zhì)與安全,推動(dòng)合規(guī)與創(chuàng)新,彰顯品牌競(jìng)爭(zhēng)力,實(shí)現(xiàn)更高質(zhì)量、更健康、更安全、更綠色的可持續(xù)發(fā)展。

權(quán)威公正 傳遞信任
彰顯品質(zhì) 創(chuàng)造價(jià)值
有源醫(yī)療器械檢測(cè)

CTI華測(cè)檢測(cè)為全球有源醫(yī)療器械客戶提供一站式測(cè)試、檢驗(yàn)、認(rèn)證、審核、培訓(xùn)及技術(shù)服務(wù),包括醫(yī)用診察和監(jiān)護(hù)、急救、物理治療、消毒滅菌、康復(fù)、臨床檢驗(yàn)設(shè)備等有源醫(yī)療器械安規(guī)、EMC、電磁兼容、可靠性、老化等有源醫(yī)療器械注冊(cè)的安全性、有效性研究等一站式解決方案。

有源醫(yī)療器械檢測(cè)

服務(wù)背景

依據(jù)《醫(yī)療器械注冊(cè)管理辦法》(局令第16號(hào))中的規(guī)定,第二類、第三類醫(yī)療器械由國(guó)家食品藥品監(jiān)督管理局會(huì)同國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局認(rèn)可的醫(yī)療器械檢測(cè)機(jī)構(gòu)進(jìn)行注冊(cè)檢測(cè),醫(yī)療器械檢測(cè)機(jī)構(gòu)應(yīng)當(dāng)在國(guó)家食品藥品監(jiān)督管理局和國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局認(rèn)可的檢測(cè)范圍內(nèi),依據(jù)生產(chǎn)企業(yè)申報(bào)適用的產(chǎn)品標(biāo)準(zhǔn)(包括適用的國(guó)家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)或者生產(chǎn)企業(yè)制定的注冊(cè)產(chǎn)品標(biāo)準(zhǔn))對(duì)申報(bào)產(chǎn)品進(jìn)行注冊(cè)檢測(cè),并出具檢測(cè)報(bào)告,方可用于臨床試驗(yàn)或者申請(qǐng)注冊(cè)。
注冊(cè)檢測(cè)作為醫(yī)療器械注冊(cè)過(guò)程中重要的一環(huán),其目的是為了驗(yàn)證醫(yī)療器械產(chǎn)品的性能要求及安全要求是否符合產(chǎn)品注冊(cè)標(biāo)準(zhǔn)(或國(guó)家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn))的規(guī)定,保證產(chǎn)品的有效性能和使用安全。只有通過(guò)了注冊(cè)檢測(cè)的產(chǎn)品,方可進(jìn)行下一步的臨床試驗(yàn)和最終的產(chǎn)品注冊(cè)。

 

適用產(chǎn)品范圍

1、醫(yī)用診察和監(jiān)護(hù)器械:多參數(shù)監(jiān)護(hù)儀、心電圖機(jī)、脈搏血氧儀、血壓計(jì)、電子和紅外體溫計(jì)

2、呼吸、麻醉和急救器械:家用呼吸機(jī)、醫(yī)用分子篩制氧機(jī)、家用分子篩制氧機(jī)、小型醫(yī)用制氧機(jī)、便攜式制氧機(jī)、醫(yī)用氧氣濃縮器、醫(yī)用超聲霧化器、醫(yī)用壓縮式霧化器、醫(yī)用霧化器

3、物理治療器械:神經(jīng)和肌肉刺激器、低頻電療儀、中低頻治療儀、熱墊式治療儀、特定電磁波治療儀、遠(yuǎn)紅外輻射治療儀、紅外熱輻射理療燈、特定電磁波治療器、電位治療設(shè)備、紅光治療設(shè)備、紫外治療設(shè)備

4、醫(yī)療器械消毒滅菌器械:醫(yī)用清洗器、醫(yī)用超聲波清洗器注輸、護(hù)理和防護(hù)器械:醫(yī)用防護(hù)口罩、醫(yī)用外科口罩、一次性使用醫(yī)用口罩、日常防護(hù)型口罩、呼吸防護(hù) 自吸過(guò)濾式防顆粒物呼吸器、兒童口罩、針織口罩

5、患者承載器械:手動(dòng)病床、電動(dòng)病床

6、醫(yī)用康復(fù)器械:助聽(tīng)器、手動(dòng)輪椅車

7、臨床檢驗(yàn)設(shè)備:離心機(jī)、核酸提取儀、全自動(dòng)核酸提取儀、全自動(dòng)核酸純化儀、全自動(dòng)核酸提取純化儀、醫(yī)用冷藏箱、醫(yī)用冷凍箱、醫(yī)用冷藏冷凍箱、醫(yī)用超低溫冷凍箱、樣品前處理系統(tǒng)、樣品檢查自動(dòng)化系統(tǒng)、全自動(dòng)樣品處理系統(tǒng)、樣品后處理系統(tǒng)、分杯處理系統(tǒng)、樣本處理及孵育系統(tǒng)

7、醫(yī)用軟件:體外診斷類軟件等

 

有源醫(yī)療器械測(cè)試標(biāo)準(zhǔn)

● 體外診斷類設(shè)備 / in vitro diagnostic medical devices

名稱/Title

國(guó)際標(biāo)準(zhǔn)/international standards

國(guó)內(nèi)標(biāo)準(zhǔn)/National standards

測(cè)量、控制和試驗(yàn)室用電氣設(shè)備的安全要求 

Electrical Equipment For Measurement, 
Control ,and Laboratory Use

IEC/EN 61010-1

GB4793.1
GB/T42125.1

測(cè)量、控制和試驗(yàn)室用電氣設(shè)備的安全要求
第2-101部分:體外診斷(IVD)醫(yī)用設(shè)備的專用要求

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

測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求:實(shí)驗(yàn)室用分析和其他目的自動(dòng)和半自動(dòng)設(shè)備的特殊要求

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

測(cè)量、控制和實(shí)驗(yàn)室用的電設(shè)備 電磁兼容性要求 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

測(cè)量、控制和實(shí)驗(yàn)室用電設(shè)備.電磁兼容性(EMC)的要求.特殊要求.實(shí)驗(yàn)室診斷

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

 

● 醫(yī)用電器設(shè)備檢測(cè)標(biāo)準(zhǔn) / Medical Device testing standards list

名稱

國(guó)際標(biāo)準(zhǔn)

國(guó)內(nèi)標(biāo)準(zhǔn)

醫(yī)用電氣設(shè)備 第2部分 心電圖機(jī)安全專用要求

Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements

IEC/EN 60601-2-25

GB 10793  
GB 9706.225

無(wú)創(chuàng)血壓計(jì)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

 

無(wú)創(chuàng)血壓計(jì).第3部分:電-機(jī)血壓測(cè)量系統(tǒng)的補(bǔ)充要求

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

 

EN 1060-3

 

 

醫(yī)用電氣設(shè)備 第2-27部分:心電監(jiān)護(hù)安全及基本性能專用要求

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

醫(yī)用電氣設(shè)備 第2-26部分:腦電圖機(jī)安全專用要求

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

醫(yī)用電氣設(shè)備 第2-56部分:臨床體溫計(jì)的基本安全和性能的專用要求

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

血壓計(jì)

Non-invasive automated sphygmomanometers

ANSI/AAMI SP10

YY 0670

醫(yī)用電氣設(shè)備--第2-57部分:治療、診斷、監(jiān)測(cè)和美容/美學(xué)使用的非激光光源設(shè)備的基本安全和基本性能專用要求

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

醫(yī)用電氣設(shè)備 第2-2部分:高頻手術(shù)設(shè)備安全專用要求

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

醫(yī)用電氣設(shè)備第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

醫(yī)用電氣設(shè)備第2-10部分:神經(jīng)和肌肉刺激器安全專用要求

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

醫(yī)用電氣設(shè)備 第2-30部分:自動(dòng)循環(huán)無(wú)創(chuàng)血壓監(jiān)護(hù)設(shè)備的安全和基本性能專用要求

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

醫(yī)用電氣設(shè)備 第2-49部分:多參數(shù)患者監(jiān)護(hù)設(shè)備安全專用要求

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

醫(yī)用電氣設(shè)備.醫(yī)用脈搏血氧儀設(shè)備基本安全和主要性能專用要求

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

醫(yī)用電氣設(shè)備 第2-38部分:醫(yī)院電動(dòng)床安全專用要求 
醫(yī)用電氣設(shè)備 第2-52部分:醫(yī)院電動(dòng)床安全專用要求 

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

心電診斷設(shè)備

Diagnostic electrocardiographic devices       

ANSI/AAMI EC11

YY 1139

醫(yī)用電氣設(shè)備 第1-11部分:安全及基本性能的通用要求—并列標(biāo)準(zhǔn):家庭醫(yī)療保健環(huán)境下使用的醫(yī)用電氣設(shè)備和系統(tǒng)

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

醫(yī)用體溫計(jì).最大裝置小型電體溫計(jì)(非預(yù)測(cè)型和預(yù)測(cè)型)的性能

Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

EN 12470-3
ASTM E1112

 

臨床體溫計(jì).連續(xù)測(cè)量用電子體溫計(jì)的性能

Performance of electrical thermometers

EN 12470-4

YY 0785

紅外體溫計(jì)

infrared ear thermometers (with maximum device)

EN 12470-5
ASTM E1965-98

GB/T 21417.1

醫(yī)用電氣設(shè)備 第2部分:動(dòng)態(tài)心電圖系統(tǒng)安全和基本性能專用要求

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

醫(yī)用電氣設(shè)備 第2部分:診斷和治療激光設(shè)備安全專用要求

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

醫(yī)用電氣設(shè)備.第2部分:手術(shù)無(wú)影燈和診斷用照明燈安全專用要求

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

醫(yī)用電氣設(shè)備 第2部分:手術(shù)臺(tái)安全專用要求

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

心電監(jiān)護(hù)儀電纜和導(dǎo)聯(lián)線

ECG trunk cables and patient leadwires

AAMI ANSI EC53

YY 0828

醫(yī)用電氣設(shè)備 第2-18部分:內(nèi)窺鏡設(shè)備安全專用要求

Part performance 2-18: Particular of endoscopic requirements equipment

 

IEC/EN 60601-2-18

 

GB9706.19
GB 9706.218

醫(yī)用電氣設(shè)備 第1-2 部分:安全通用要求 并列標(biāo)準(zhǔn):電磁兼容 要求和試驗(yàn)

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

醫(yī)用電氣設(shè)備 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列標(biāo)準(zhǔn): 通用要求,醫(yī)療電氣設(shè)備和醫(yī)療電氣系中統(tǒng)報(bào)警系統(tǒng)的測(cè)試和指南

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

激光產(chǎn)品的安全 第1 部分:設(shè)備分類和要求

Safety of laser products —Part 1: Equipment classification and requirements

IEC/EN 60825-1
AS/NZS 2211.1

GB 7247.1

燈和燈系統(tǒng)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

呼吸治療設(shè)備,第1部分:霧化系統(tǒng)及其組成部分RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components

EN13544-1
ISO 27427

YY 0109

醫(yī)用電氣設(shè)備--第2-24部分:輸液泵及控制器的基本安全和基本性能專用要求

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

醫(yī)用電氣設(shè)備--第2-34部分:有創(chuàng)血壓監(jiān)護(hù)設(shè)備的基本安全和基本性能專用要求

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

醫(yī)用電氣設(shè)備 2-60部分:牙科設(shè)備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

醫(yī)用設(shè)備 - 第一部分:醫(yī)用設(shè)備可用性工程的應(yīng)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

醫(yī)用電氣設(shè)備 - 第1-6部分:基本安全和基本性能的通用要求 - 并列標(biāo)準(zhǔn):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

醫(yī)用電氣設(shè)備 第2部分:嬰兒培養(yǎng)箱安全專用要求

Medical electrical equipment -Part 2:Particular requirements for safety of baby incubators

 

IEC/EN 60601-2-19

 

GB 9706.219

醫(yī)療電氣設(shè)備-第1-9部分:基本安全和重要性能的一般要求.附屬標(biāo)準(zhǔn):環(huán)境意識(shí)設(shè)計(jì)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

 

 

醫(yī)用電子體溫計(jì)

Clinical electronic thermometer

 

GB/T21416

醫(yī)療器械軟件 軟件生存周期過(guò)程

Medical device software — Software life cycle processes

 

IEC62304 

 

YY/T 0664

醫(yī)用吸引設(shè)備 第1部分: 電動(dòng)吸引設(shè)備 安全要求

Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements

 

ISO10079-1

 

YY/T 0636.1

醫(yī)用電氣設(shè)備 第2-37部分:超聲醫(yī)療診斷監(jiān)視設(shè)備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

醫(yī)用超聲診斷設(shè)備聲輸出公布要求

 

IEC 61157

GB/T16846

醫(yī)療診斷超聲波設(shè)備的聲輸出報(bào)告用標(biāo)準(zhǔn)方法

Ultrasonics  dental  descaler systems; measurement and declaration of the output characteristics

IEC 61205

YY/T 0751

超聲多普勒胎兒心率儀

ultrasonic Doppler fetal heartbeat detector

 

YY 0448

超聲多普勒胎兒監(jiān)護(hù)儀

ultrasonic Doppler fetal monitor

 

YY/T0449

超聲理療設(shè)備

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

超聲 水聽(tīng)器 第1部分:40MHz 以下醫(yī)用超聲場(chǎng)的測(cè)量和特征描繪 

ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ

IEC62127-1

YY/T 0865.1

醫(yī)用內(nèi)窺鏡

IEC/EN 60601-2-18

YY 0068.1, YY 0068.2, YY/T 0068.3 ,YY 0068.4

醫(yī)用膠囊式內(nèi)窺鏡

 

YY 1298

醫(yī)用內(nèi)窺鏡照明用光纜

 

YY/T 0763

醫(yī)用電子內(nèi)窺鏡

 

YY 1587

醫(yī)用內(nèi)窺鏡 內(nèi)窺鏡功能供給裝置 攝像系統(tǒng)

 

YY/T1603

環(huán)境試驗(yàn)要求及試驗(yàn)方法

 

GB/T14710

產(chǎn)品加速老化試驗(yàn)方法

IEC62506

GB/T34986

 

● 電池要求和部分家電產(chǎn)品檢測(cè)標(biāo)準(zhǔn) / Battery and household appliance testing standards

便攜式和便攜式裝置用密封含堿性電解液二次電池的安全要求

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

聯(lián)合國(guó)《關(guān)于危險(xiǎn)貨物運(yùn)輸?shù)慕ㄗh書 標(biāo)準(zhǔn)與試驗(yàn)手冊(cè)》38.3 章

recommendations on the transportation of dangerous goods manual of tests and criteria

UN DOT 38.3

 

家用和類似用途電器的安全 口腔衛(wèi)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

家用和類似用途電器的安全加濕器的特殊要求 Household and similar electrical appliances - Safety - Particular requirements for humidifiers

IEC/EN 60335-2-98
AS/NZS 60335.2.98

GB 4706.48

家用和類似用途電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

 

家用和類似用途電器的安全 暖腳器和熱腳墊的特殊要求

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

 

家用和類似用途電器的安全紫外線和紅外線輻射皮膚器具 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

 

家用和類似用途電器的安全結(jié)合激光和強(qiáng)烈光源的美容和美容護(hù)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

 

 

● 無(wú)線醫(yī)療的檢測(cè)標(biāo)準(zhǔn)和法規(guī)要求 / Wireless Product testing standards

工作頻段/Frequency

測(cè)試標(biāo)準(zhǔn)

典型產(chǎn)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

藍(lán)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功能傳輸數(shù)據(jù) 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功能傳輸數(shù)據(jù) Use LTE function to transfer data

868MHZ

禁用Prohibited

EN300 220
EN301 489-1/3
EN60950-1/EN62368
EN62479

用ASK、FSK類調(diào)制傳輸數(shù)據(jù)類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類調(diào)制傳輸數(shù)據(jù)類 Use ASK, FSK function to transfer data

 

● 可靠性測(cè)試和失效分析 / Reliability and Failure mode analysis

測(cè)試類別及依據(jù) 測(cè)試項(xiàng)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.
恒溫恒濕Constant Temprature and Humidity
振動(dòng)Vibration
鹽霧Salt Spray
溫度濕度循環(huán)Temprature & Humidity Cycling
壽命分析Life Analysi
臭氧老化Ozone Aging
防水防塵Waterproof and Dustproof
震動(dòng)&溫度&濕度Vitration & Temprature & Humidity
高加速壽命試驗(yàn)HALT/HASS/HASA
失 效 分 析 與 預(yù) 防
Failure Analysis and Prevention

 IPC/ECAJ-STD,IPCTM    650-2
iS016232-10,etc.
PCB&PCBA失效分析和評(píng)估、PCB& PCBA Analysis and Evaluation
IC可靠性設(shè)計(jì)分析Reliability Design and Analysis of IC
無(wú)損檢測(cè)Non-destructive Testing
涂鍍層Coating and Palte Analysis
材料熱學(xué)Material Thermal
材料硬度Materal Hardness
掃描電鏡能譜分析SEM-EDS

 

軟件測(cè)評(píng) / Software evaluation

軟件測(cè)評(píng)服務(wù)主要包括:通用應(yīng)用軟件測(cè)評(píng)、APP安全檢測(cè)、信息安全服務(wù)三個(gè)測(cè)評(píng)服務(wù)方向。

The software evaluation service includes general software evaluation, APP security test , information security.  

GB/T 25000.51-2016《系統(tǒng)與軟件工程系統(tǒng)與軟件質(zhì)量要求和評(píng)價(jià)(SQuaRE)第51部分:就緒可用軟件產(chǎn)品(RUSP)的質(zhì)量要求和測(cè)試細(xì)則》 IEC/ISO25051

System and software engineering -&nb

 

常規(guī)樣品要求

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