作為中國第三方檢測與認(rèn)證服務(wù)的開拓者和領(lǐng)先者，CTI華測檢測為全球客戶提供一站式檢驗、測試、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，推動合規(guī)與創(chuàng)新，彰顯品牌競爭力，實現(xiàn)更高質(zhì)量、更健康、更安全、更綠色的可持續(xù)發(fā)展。
醫(yī)療電氣設(shè)備的線性變壓器繞組應(yīng)有足夠的絕緣以防止可能引起內(nèi)部短路過熱而導(dǎo)致的危險狀況。變壓器倍頻倍壓是保障醫(yī)療電氣產(chǎn)品安全的重要試驗之一，用來評價醫(yī)療電氣產(chǎn)品的質(zhì)量和電氣安全特性。CTI華測檢測為您提供醫(yī)用電器設(shè)備檢測，電子電器相關(guān)的變壓器倍壓倍頻測試，可為醫(yī)用電器設(shè)備客戶提供有源醫(yī)械安全測試、安規(guī)測試、EMC測試、軟件測評等測試服務(wù)。
醫(yī)用電器設(shè)備安全檢測旨在評估醫(yī)療機構(gòu)的電器設(shè)備是否符合相關(guān)的安全標(biāo)準(zhǔn)和法規(guī)要求，以確保設(shè)備在正常使用情況下不會對患者、醫(yī)護人員和環(huán)境造成危害。
● 保障醫(yī)療安全
通過醫(yī)用電器設(shè)備安全檢測，可以發(fā)現(xiàn)并修復(fù)醫(yī)用電器設(shè)備中可能存在的安全隱患，降低事故發(fā)生的風(fēng)險，保障醫(yī)療安全。
● 遵守法律法規(guī)
醫(yī)用電器設(shè)備安全檢測是遵守國家及地方有關(guān)電器設(shè)備安全法規(guī)和標(biāo)準(zhǔn)的要求，是保障患者和醫(yī)護人員安全的重要手段 。
醫(yī)用診察和監(jiān)護器械：多參數(shù)監(jiān)護儀、心電圖機、脈搏血氧儀、血壓計、電子和紅外體溫計。
呼吸、麻醉和急救器械：家用呼吸機、醫(yī)用分子篩制氧機、家用分子篩制氧機、小型醫(yī)用制氧機、便攜式制氧機、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。
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。
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、護理和防護器械：醫(yī)用防護口罩、醫(yī)用外科口罩、一次性使用醫(yī)用口罩、日常防護型口罩、呼吸防護 自吸過濾式防顆粒物呼吸器、兒童口罩、針織口罩。
患者承載器械：手動病床、電動病床。
醫(yī)用康復(fù)器械：助聽器、手動輪椅車。
臨床檢驗設(shè)備：離心機、核酸提取儀、全自動核酸提取儀、全自動核酸純化儀、全自動核酸提取純化儀、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)、樣品檢查自動化系統(tǒng)、全自動樣品處理系統(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)。
醫(yī)用軟件：體外診斷類軟件等。
● 醫(yī)用電器設(shè)備檢測標(biāo)準(zhǔn) / Medical Device testing standards list
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名稱 |
國際標(biāo)準(zhǔn) |
國內(nèi)標(biāo)準(zhǔn) |
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醫(yī)用電氣設(shè)備 第2部分 心電圖機安全專用要求 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements |
IEC/EN 60601-2-25 |
GB 10793 |
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無創(chuàng)血壓計第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 |
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無創(chuàng)血壓計.第3部分:電-機血壓測量系統(tǒng)的補充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3
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醫(yī)用電氣設(shè)備 第2-27部分：心電監(jiān)護安全及基本性能專用要求 Medical electrical equipment - Part 2-27: Particular requirements for the basi csafety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27
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GB 9706.25 |
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醫(yī)用電氣設(shè)備 第2-26部分：腦電圖機安全專用要求 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC/EN 60601-2-26:2012 |
GB 9706.26 |
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醫(yī)用電氣設(shè)備 第2-56部分:臨床體溫計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 |
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血壓計 Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
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醫(yī)用電氣設(shè)備--第2-57部分:治療、診斷、監(jiān)測和美容/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
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YY 9706.257 |
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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 |
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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 |
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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
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YY 0607 |
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醫(yī)用電氣設(shè)備 第2-30部分:自動循環(huán)無創(chuàng)血壓監(jiān)護設(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 |
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YY 0667 |
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醫(yī)用電氣設(shè)備 第2-49部分：多參數(shù)患者監(jiān)護設(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 |
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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
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YY 0784 |
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醫(yī)用電氣設(shè)備 第2-38部分:醫(yī)院電動床安全專用要求 Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds |
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YY 0571 |
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心電診斷設(shè)備 Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
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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
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YY 9706.111 |
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醫(yī)用體溫計.最大裝置小型電體溫計(非預(yù)測型和預(yù)測型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 |
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臨床體溫計.連續(xù)測量用電子體溫計的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
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紅外體溫計 infrared ear thermometers (with maximum device)
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EN 12470-5
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GB/T 21417.1 |
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醫(yī)用電氣設(shè)備 第2部分：動態(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 |
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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
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GB 9706.20 |
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醫(yī)用電氣設(shè)備.第2部分:手術(shù)無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 |
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醫(yī)用電氣設(shè)備 第2部分：手術(shù)臺安全專用要求 Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46
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YY 0570 |
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心電監(jiān)護儀電纜和導(dǎo)聯(lián)線 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
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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
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GB9706.19 |
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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 Medical electrical equipment-Part 1-2:General requirements for safetyCollateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2
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YY 0505 YY9706.102 |
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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)報警系統(tǒng)的測試和指南 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
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YY0709 |
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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 |
GB 7247.1 |
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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 |
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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 |
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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
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GB 9706.27 |
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醫(yī)用電氣設(shè)備--第2-34部分:有創(chuàng)血壓監(jiān)護設(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
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YY0783 |
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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
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GB 9706.260 |
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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
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YY/T 1474 |
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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
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YY/T 9706.106 |
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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
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GB 9706.219 |
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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)境意識設(shè)計的要求 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
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醫(yī)用電子體溫計 Clinical electronic thermometer |
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GB/T21416 |
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醫(yī)療器械軟件 軟件生存周期過程 Medical device software — Software life cycle processes |
IEC62304
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YY/T 0664 |
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醫(yī)用吸引設(shè)備 第1部分: 電動吸引設(shè)備 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1
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YY/T 0636.1 |
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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 |
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醫(yī)用超聲診斷設(shè)備聲輸出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 |
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醫(yī)療診斷超聲波設(shè)備的聲輸出報告用標(biāo)準(zhǔn)方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
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超聲多普勒胎兒心率儀 ultrasonic Doppler fetal heartbeat detector |
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YY 0448 |
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超聲多普勒胎兒監(jiān)護儀 ultrasonic Doppler fetal monitor |
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YY/T0449 |
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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
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超聲 水聽器 第1部分：40MHz 以下醫(yī)用超聲場的測量和特征描繪 ultrasonic-Hydrophone Part 1: Measurement and characterization of medical ultrasonic fields to 40MHZ |
IEC62127-1 |
YY/T 0865.1 |
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醫(yī)用內(nèi)窺鏡 |
IEC/EN 60601-2-18 |
YY 0068.1 |
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醫(yī)用膠囊式內(nèi)窺鏡 |
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YY 1298 |
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醫(yī)用內(nèi)窺鏡照明用光纜 |
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YY/T 0763 |
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醫(yī)用電子內(nèi)窺鏡 |
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YY 1587 |
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醫(yī)用內(nèi)窺鏡 內(nèi)窺鏡功能供給裝置 攝像系統(tǒng) |
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YY/T1603 |
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環(huán)境試驗要求及試驗方法 |
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GB/T14710 |
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產(chǎn)品加速老化試驗方法 |
IEC62506 |
GB/T34986 |
● 軟件測評 / Software evaluation
● 軟件測評服務(wù)主要包括：通用應(yīng)用軟件測評、APP安全檢測、信息安全服務(wù)三個測評服務(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)量要求和評價（SQuaRE）第51部分：就緒可用軟件產(chǎn)品（RUSP）的質(zhì)量要求和測試細則》 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 《系統(tǒng)與軟件工程系統(tǒng)與軟件質(zhì)量要求和評價（SQuaRE）第10部分：系統(tǒng)與軟件質(zhì)量模型 IEC/ISO25010
System and software engineering - System and software quality requirements and evaluation(SQuaRE)- part 10 System and software quality models
● 網(wǎng)絡(luò)安全和漏洞評估
● YY/T1843-2022 醫(yī)用電氣系統(tǒng)及醫(yī)療器械軟件的網(wǎng)絡(luò)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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