| 名稱 | 國際標準 | 國內(nèi)標準 |
| 電氣設(shè)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
GB 9706.225 |
| 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(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 basic safety and essential performance of electrocardiographic monitoring equipment | IEC/EN 60601-2-27 | GB 9706.25
GB9706.227 |
| 電氣設(shè)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
IEC 80601-2-26：2019 | GB 9706.26
GB9706.226 |
| 電氣設(shè)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(shè)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(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 |
| 電氣設(shè)備 第2-2部分: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
GB 9706.204 |
| 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
EN /IEC60601-1 | GB9706.1 |
| 電氣設(shè)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
GB9706.210 |
| 電氣設(shè)備 第2-30部分:自動循環(huán)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 |
IEC/EN 80601-2-30
| YY 0667
YY 9706.230 |
| 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
YY 9706.249 |
| 電氣設(shè)備.脈搏設(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
YY 9706.261 |
| 電氣設(shè)備 第2-38部分:醫(yī)院電動床安全專用要求
電氣設(shè)備 第2-52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
YY 9706.252 |
| 心電診斷設(shè)備 Diagnostic electrocardiographic devices | ANSI/AAMI EC11 | YY 1139 |
| 電氣設(shè)備 第1-11部分：安全及基本性能的通用要求—并列標準：家庭醫(yī)療保健環(huán)境下使用的電氣設(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 |
| .裝置小型電(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
ASTM E1112 | |
| 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
ASTM E1965-98 | GB/T 21417.1 |
| 電氣設(shè)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
ANSI/AAMI EC38:2007
AAMI/ANSI/ISO 60601-2-47:2012 | YY 0885
YY 9706.247 |
| 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
GB9706.222 |
| 電氣設(shè)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
YY 9706.241 |
| 電氣設(shè)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
YY 9706.246 |
| 電纜和導(dǎo)聯(lián)線 ECG trunk cables and patient leadwires | AAMI ANSI EC53 | YY 0828 |
| 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
GB 9706.218 |
| 電氣設(shè)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(shè)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(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 | YY0709
YY 9706.108 |
| 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
AS/NZS IEC 62471
IEC IEC/TR 62778
IEC/TR 62471-2 | 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
ISO 27427 | YY 0109 |
| 電氣設(shè)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
GB 9706.224 |
| 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 | YY0783
YY 9706.234 |
| 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 |
| 設(shè)備 - 部分：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 |
| 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(shè)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(shè)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(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 | |
| 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(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 | YY/T 0636.1 |
| 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
GB10152
GB9706.237 |
| Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment 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(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
GB9706.7
GB9706.205 |
| 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 |
