服務背景
單一故障：指的是醫療設備只有一個降低風險的措施失效，或只出現一種非正常狀態。在單一故障狀態下醫療電氣設備依舊需要保持產品安全性。單一故障是保障醫療電氣產品安全的重要試驗之一，用來評價醫療電氣產品的質量和電氣安全特性。
其醫療器械檢測是醫療器械產品進入全球市場最基本的準入門檻。產品若出口到歐盟，美國，在滿足歐盟，美國法規要求之前必須要有相對應的測試。
醫療器械其他服務內容
- 有源器械安全測試 Testing of active medical device
- 電磁兼容測試與整改服務 EMC testing and debugging service
- 可靠性測試 Reliability Testing
- NMPA註冊與備案檢測服務NMPA registration testing service
- 有效期壽命驗證Validation of product life
- 失效分析Failure mode analysis
- 生物兼容性測試 biocompatibilitytest
- 軟件測評Software evaluation
- 全球市場準入；Global marketing access
- 美國代理人服務（US Agent）；US agent service
- 歐盟代理人服務 EU representative service
- 培訓服務Training Service
醫療器械測試標準
體外診斷類設備/ in vitro diagnostic medical devices
|
序號 |
名稱 |
國際標準 |
國內標準 |
|
1 |
測量、控製和試驗室用電氣設備的安全要求 Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
測量、控製和試驗室用電氣設備的安全要求第2-101部分：體外診斷(IVD)醫用設備的專用要求 Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
|
3 |
測量、控製和實驗室用電氣設備的安全要求：實驗室用分析和其他目的自動和半自動設備的特殊要求 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 |
|
4 |
測量、控製和實驗室用的電設備 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 |
|
5 |
測量、控製和實驗室用電設備.電磁兼容性(EMC)的要求.特殊要求.實驗室診斷 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 |
醫用電器設備檢測標準/Medical Device testing standards list
|
序號 |
名稱 |
國際標準 |
國內標準 |
|
1 |
醫用電氣設備 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 |
|
2 |
無創血壓計第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 |
|
|
3 |
無創血壓計.第3部分:電-機血壓測量系統的補充要求 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 1060-3 |
|
|
4 |
醫用電氣設備 第1-1部分：通用安全要求 並列標準醫用電氣系統安全要求 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
IEC/EN 60601-1-1 |
GB 9706.15 |
|
5 |
醫用電氣設備 第2-27部分：心電監護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 |
|
7 |
醫用電氣設備 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 IEC 80601-2-26：2019 |
GB 9706.26 |
|
8 |
醫用電氣設備 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 |
|
|
9 |
血壓計Non-invasive automated sphygmomanometers |
ANSI/AAMI SP10 |
YY 0670 |
|
10 |
醫用電氣設備--第2-57部分:治療、診斷、監測和美容/美學使用的非激光光源設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 |
|
|
11 |
醫用電氣設備 第2-2部分:高頻手術設備安全專用要求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 |
|
12 |
醫用電氣設備第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 |
|
13 |
醫用電氣設備第2-10部分:神經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 |
IECC/EN 60601-2-10 |
YY 0607 |
|
14 |
醫用電氣設備 第2-30部分:自動循環無創血壓監護設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 |
|
15 |
醫用電氣設備 第2-49部分：多參數患者監護設備安全專用要求Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment |
IEC/EN 60601-2-49/IEC 80601-2-49 |
YY 0668 |
|
16 |
醫用電氣設備.醫用脈搏血氧儀設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 |
EN ISO 9919 ISO / EN ISO 80601-2-61 |
YY 0784 |
|
18 |
醫用電氣設備 第2-38部分:醫院電動床安全專用要求 醫用電氣設備 第2-52部分:醫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 |
IEC/EN 60601-2-52 |
YY 0571 |
|
19 |
醫用電氣設備 第2-51 部分：記錄和分析型單道和多道心電圖機安全和基本性能專用要求 Part 2-51: Particular requirements for safety, including essentialperformance,of recording and analysing single channel and multichannelelectrocardiographs |
IEC/EN 60601-2-51 |
YY 0782-2010 |
|
20 |
心電診斷設備Diagnostic electrocardiographic devices |
ANSI/AAMI EC11 |
YY 1139 |
|
21 |
心電監護設備Electrocardiographic |
ANSI/AAMI EC13 |
YY1079 |
|
22 |
醫用電氣設備 第1-11部分：安全及基本性能的通用要求—並列標準：家庭醫療保健環境下使用的醫用電氣設備和系統 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 |
|
|
23 |
醫用體溫計.最大裝置小型電體溫計(非預測型和預測型)的性能 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-3 ASTM E1112 |
|
|
24 |
臨床體溫計.連續測量用電子體溫計的性能 Performance of electrical thermometers |
EN 12470-4 |
YY 0785 |
|
25 |
紅外體溫計 infrared ear thermometers (with maximum device) |
EN 12470-5 ASTM E1965-98 |
GB/T 21417.1 |
|
26 |
醫用電氣設備 第2部分：動態心電圖系統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 |
|
27 |
醫用電氣設備 第2部分：診斷和治療激光設備安全專用要求 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 |
|
28 |
醫用電氣設備.第2部分:手術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 |
|
29 |
醫用電氣設備 第2部分：手術臺安全專用要求Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
IEC/EN 60601-2-46 |
YY 0570 |
|
30 |
心電監護儀電纜和導聯線 ECG trunk cables and patient leadwires |
AAMI ANSI EC53 |
YY 0828 |
|
31 |
醫用電氣設備 第2-18部分:內窺鏡設備安全專用要求 Part performance 2-18: Particular of endoscopic requirements equipment |
IEC/EN 60601-2-18 |
GB9706.19 |
|
32 |
醫用電氣設備 第1-2 部分：安全通用要求 並列標準：電磁兼容 要求和試驗 Medical electrical equipment-Part 1-2:General requirements for safety Collateral standard :Electromagnetic compatibility-Requirements and tests |
IEC/EN 60601-1-2 |
YY 0505 |
|
37 |
醫用電氣設備 - 第1-8 部分:基本安全和基本性能的通用要求 - 並列標準: 通用要求，醫療電氣設備和醫療電氣系中統報警系統的測試和指南 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 |
YY0709 |
|
38 |
激光產品的安全 第1 部分:設備分類和要求 Safety of laser products —Part 1: Equipment classification and requirements |
IEC/EN 60825-1 AS/NZS 2211.1 |
GB 7247.1 |
|
39 |
燈和燈系統的光生物安全性 Photobiological safety of lamps and lamp systems |
IEC /EN62471 AS/NZS IEC 62471 IEC IEC/TR 62778 IEC/TR 62471-2 |
GB/T 20145 |
|
40 |
呼吸治療設備,第1部分:霧化系統及其組成部分 RESPIRATORY THERAPY EQUIPMENT –Part 1: Nebulizing systems and their components |
EN13544-1 |
YY 0109 |
|
41 |
醫用電氣設備--第2-24部分:輸液泵及控製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 |
|
42 |
醫用電氣設備--第2-34部分:有創血壓監護設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 |
|
43 |
醫用電氣設備 2-60部分：牙科設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 |
|
|
44 |
醫用設備 - 第一部分：醫用設備可用性工程的應用 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 |
|
45 |
醫用電氣設備 - 第1-6部分：基本安全和基本性能的通用要求 - 並列標準：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 |
|
|
46 |
醫用電氣設備 第2部分:嬰兒培養箱安全專用要求 Medical electrical equipment -Part 2:Particular requirements for safety ofbaby incubators |
IEC/EN 60601-2-19 |
GB 11243 |
|
47 |
醫療電氣設備-第1-9部分:基本安全和重要性能的一般要求.附屬標準:環境意識設計的要求 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 |
|
|
48 |
醫用電子體溫計 Clinical electronic thermometer |
GB/T21416 |
|
|
49 |
醫療器械軟件 軟件生存周期過程 Medical device software — Software life cycle processes |
IEC62304 |
YY/T 0664 |
|
50 |
醫用吸引設備 第1部分: 電動吸引設備 安全要求 Medical suction equipment Part 1: Electrically powered suction equipment — Safety requirements |
ISO10079-1 |
|
|
51 |
醫用電氣設備 第2-37部分：超聲醫療診斷監視設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 |
EN 60601-2-37 |
GB 9706.9-2008 GB10152-2009 |
|
52 |
醫用超聲診斷設備聲輸出公布要求 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
IEC 61157 |
GB/T16846 UD2 UD3 |
|
53 |
醫療診斷超聲波設備的聲輸出報告用標準方法 Ultrasonics dental descaler systems; measurement and declaration of the output characteristics |
IEC 61205 |
YY/T 0751 |
|
54 |
超聲多普勒胎兒心率儀/ultrasonic Doppler fetal heartbeat detector |
YY 0448 |
|
|
55 |
超聲多普勒胎兒監護儀ultrasonic Doppler fetal monitor |
YY/T0449 |
|
|
56 |
超聲理療設備 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 |
|
57 |
超聲水聽器 第1部分：40MHz 以下醫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 |
適用產品範圍
醫療器械產品（包括：體溫計，血氧儀，血壓計，胎心儀，心電圖機，彩超，X光機等）。
常規樣品要求
完整能正常工作的樣機，其他具體詳情請咨詢CTI在線客服。
我們的優勢
- CTI具有專業資質、經驗豐富的技術專家團隊，為您提供專業咨詢和服務。
- CTI擁有先進的實驗室設備，確保測試數據的準確和可靠。
- CTI作為全球客戶信賴的第三方測試認證機構，我們是您品質的背書。
- 我們憑借遍布全球的實驗室網絡，為您提供全面完善的一站式測試認證解決方案。
常見問題
CTI的醫療器械檢測的測試周期是多久？
實際周期根據委托的產品標準來確定，請與CTI客服聯系確認。
CTI醫療器械檢測的測試方法是什麽？
針對產品的出口要以及客戶委托的要求，進行標準檢測。
CTI對於樣品的留樣周期是多久？
退樣。
