服務背景
模壓：模壓是保證醫療電氣產品模壓或註塑成形的熱塑性材料外殼應構造得，由模壓或註塑成形產生的內應力釋放所引起材料的任何收縮或變形，不會導致不可接受的風險。測試是將完整的醫療 設備或與任何支撐框架一起組成的外殼作為一個樣品，放入空氣循環的特定溫度的烘箱內，測試後樣品冷卻至室溫後，外殼的收縮或變形，不會導致不可接受的風險。模壓測試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外殼的安全特性。
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。
