通過(guò)構(gòu)建覆蓋戰(zhàn)略決策層、管理執(zhí)行層和業(yè)務(wù)運(yùn)營(yíng)層的全價(jià)值鏈ESG治理體系,積極實(shí)踐對(duì)ESG風(fēng)險(xiǎn)機(jī)遇的穿透式管理,賦能全產(chǎn)業(yè)鏈可持續(xù)發(fā)展。
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)。
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。
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。
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。
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)。
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
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, |
IEC/EN 61010-1 |
GB4793.1 |
測(cè)量、控制和試驗(yàn)室用電氣設(shè)備的安全要求 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 |
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 |
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 |
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 |
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 |
GB 9706.26 |
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 |
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 |
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 |
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 |
|
YY 0667 |
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 |
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 |
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 Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds |
IEC/EN 60601-2-52
|
YY 0571 |
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 |
|
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 |
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 |
YY 0885 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
|
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 |
|
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 |
EN300328 |
藍(lán)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 |
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 |
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 |
EN300 220 |
用ASK、FSK類調(diào)制傳輸數(shù)據(jù)類 Use ASK, FSK function to transfer data |
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)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
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