適用產(chǎn)品范圍
● 診察和監(jiān)護器械：、、脈搏、、電子和
● 呼吸、麻醉和急救器械：家用、、家用、、、氧氣濃縮器、、、霧化器
● 器械：、儀、中儀、儀、特定儀、遠紅外儀、、特定器、設備、設備、紫外
● 消毒滅菌器械：清洗器、超聲波清洗器注輸、護理和防護器械：防護口罩、、一次性使用口罩、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、電動
● 康復器械：、手動車
● 臨床檢驗設備：離心機、核酸提取儀、、、、冷藏箱、冷凍箱、冷藏冷凍箱、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)、、樣本處理及孵育系統(tǒng)
● 軟件：體外診斷類軟件等
測試標準
● 體外診斷類設備 / in vitro diagnostic medical devices
| 名稱/Title | 國際標準/international standards | 國內(nèi)標準/National standards |
| 測量、控制和試驗室用電氣設備的安全要求 Electrical Equipment For Measurement, | IEC/EN 61010-1 | GB4793.1 |
| 測量、控制和試驗室用電氣設備的安全要求 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 |
| 測量、控制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 GB/T42125.14 |
| 測量、控制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 |
| 測量、控制和實驗室用電設備.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 |
● 電器設備檢測標準 / Medical Device testing standards list
| 名稱 | 國際標準 | 國內(nèi)標準 |
| 電氣設備 第2部分 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 |
| 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 |
|
| .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
|
|
| 電氣設備 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 basic safety and essential performance of electrocardiographic monitoring equipment |
IEC/EN 60601-2-27
| GB 9706.25 |
| 電氣設備 第2-26部分：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 |
| 電氣設備 第2-56部分:臨床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 |
|
Non-invasive automated sphygmomanometers | ANSI/AAMI SP10 | YY 0670 |
| 電氣設備--第2-57部分:治療、診斷、監(jiān)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
| YY 9706.257 |
| 電氣設備 第2-2部分: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 |
| 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 | GB9706.1 |
| 電氣設備第2-10部分: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 |
| 電氣設備 第2-30部分:自動循環(huán)血壓監(jiān)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 |
| YY 0667 |
| 電氣設備 第2-49部分：多參數(shù)患者監(jiān)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 80601-2-49 | YY 0668 |
| 電氣設備.脈搏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 |
ISO / EN ISO 80601-2-61
| YY 0784 |
| 電氣設備 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 |
IEC/EN 60601-2-52
| YY 0571 |
| 心電診斷設備 Diagnostic electrocardiographic devices | ANSI/AAMI EC11 | YY 1139 |
| 電氣設備 第1-11部分：安全及基本性能的通用要求—并列標準：家庭醫(yī)療保健環(huán)境下使用的電氣設備和系統(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 |
| .裝置小型電(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 |
|
| 臨床.連續(xù)測量用電子的性能 Performance of electrical thermometers | EN 12470-4 | YY 0785 |
|
infrared ear thermometers (with maximum device) | EN 12470-5 | GB/T 21417.1 |
| 電氣設備 第2部分：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 |
| 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 |
| 電氣設備.第2部分: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 |
| 電氣設備 第2部分：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 |
| 電纜和導聯(lián)線 ECG trunk cables and patient leadwires | AAMI ANSI EC53 | YY 0828 |
| 電氣設備 第2-18部分:內(nèi)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 |
| 電氣設備 第1-2 部分：安全通用要求 并列標準：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
| YY 0505 YY9706.102 |
| 電氣設備 - 第1-8 部分:基本安全和基本性能的通用要求 - 并列標準: 通用要求，醫(yī)療電氣設備和醫(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
| YY0709 |
| 激光產(chǎn)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 |
| 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,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 |
| 電氣設備--第2-24部分: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 |
| 電氣設備--第2-34部分:有創(chuàng)血壓監(jiān)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 |
| 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
| GB 9706.260 |
| 設備 - 部分：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 |
| 電氣設備 - 第1-6部分：基本安全和基本性能的通用要求 - 并列標準：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
| YY/T 9706.106 |
| 電氣設備 第2部分: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(huán)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
|
|
| 電子 Clinical electronic thermometer |
| GB/T21416 |
| 軟件 軟件生存周期過程 Medical device software — Software life cycle processes |
IEC62304
| YY/T 0664 |
| 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
| YY/T 0636.1 |
| 電氣設備 第2-37部分：超聲醫(yī)療診斷監(jiān)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 | IEC/EN 60601-2-37 | GB 9706.9 |
|
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment 超聲診斷設備聲輸出公布要求
| IEC 61157 | GB/T16846 |
| 醫(yī)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 |
| 超聲多普勒 ultrasonic Doppler fetal heartbeat detector |
| YY 0448 |
| 超聲多普勒 ultrasonic Doppler fetal monitor |
| YY/T0449 |
| 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 |
| 超聲 水聽器 第1部分：40MHz 以下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 |
| 內(nèi)窺鏡 | IEC/EN 60601-2-18 | YY 0068.1, YY 0068.2, YY/T 0068.3 ,YY 0068.4 |
| 膠囊式內(nèi)窺鏡 |
| YY 1298 |
| 內(nèi)窺鏡照明用光纜 |
| YY/T 0763 |
| 電子內(nèi)窺鏡 |
| YY 1587 |
| 內(nèi)窺鏡 內(nèi)窺鏡功能供給裝置 攝像系統(tǒng) |
| YY/T1603 |
| 環(huán)境試驗要求及試驗方法 |
| GB/T14710 |
| 產(chǎn)品加速老化試驗方法 | IEC62506 | GB/T34986 |
● 電池要求和部分家電產(chǎn)品檢測標準 / 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 | GB31241 |
| 《關于危險貨物運輸?shù)慕ㄗh書 標準與試驗手冊》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合激光和強烈光源的美容和美容護理器具的特殊要求 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 |
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● 無線醫(yī)療的檢測標準和法規(guī)要求 / Wireless Product testing standards
| 工作頻段/Frequency | 測試標準 | 典型產(chǎn)品 Typical products | |
| FCC | CE-RED | ||
| 2400MHZ-2483.5MHZ | FCC part 15 | EN300328 | 藍牙，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 |
● 可靠性測試和失效分析 / Reliability and Failure mode analysis
| 測試類別及依據(jù) | 測試項目 |
| 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&溫度&濕度Vitration & Temprature & Humidity | |
| 高加速壽命試驗HALT/HASS/HASA | |
| 失 效 分 析 與 預 防 Failure Analysis and Prevention IPC/ECAJ-STD,IPCTM 650-2 iS016232-10,etc. | PCB&PCBA失效分析和評估、PCB& PCBA Analysis and Evaluation |
| IC可靠性設計分析Reliability Design and Analysis of IC | |
| 無損檢測Non-destructive Testing | |
| 涂鍍層Coating and Palte Analysis | |
| 材料熱學Material Thermal | |
| 材料硬度Materal Hardness | |
| 掃描電鏡能譜分析SEM-EDS |
● 軟件測評 / Software evaluation
● 軟件測評服務主要包括：通用應用軟件測評、APP安全檢測、信息安全服務三個測評服務方向。
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)絡安全和漏洞評估
● YY/T1843-2022 電氣系統(tǒng)及軟件的網(wǎng)絡安全基本要求
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
