摘要: IEC 60601-1-2：2014：医用电气设备 - 第1-2部分：基本安全和基本性能的一般要求 - 附属标准：电磁干扰 - 要求和测试 国际电工委员会（IEC）发布了IEC 60601-1-2：2014，“医疗电气设备 - 第1-2部分：基本安全和基 ...
| IEC 60601-1-2：2014：医用电气设备 - 第1-2部分：基本安全和基本性能的一般要求 - 附属标准：电磁干扰 - 要求和测试 国际电工委员会（IEC）发布了IEC 60601-1-2：2014，“医疗电气设备 - 第1-2部分：基本安全和基本性能的一般要求 - 附属标准：电磁干扰 - 要求和测试”。标准可在IEC的网上商店中找到。 “IEC 60601-1-2：2014适用于医疗设备（ME）设备和ME系统的基本安全性和基本性能，存在电磁干扰和ME设备和ME系统发出的电磁干扰。IEC 60601-1的这一附属标准规定了ME设备和ME系统的电磁干扰和电磁辐射的基本安全性和基本性能的一般要求和测试。它们是对通用标准IEC 60601-1的要求的补充，并作为特定标准的基础。“ 第四版取消并取代了IEC 60601-1-2的第三版，并构成了技术修订。与上一版相比，最重大的变化包括以下修改：
（2）当适用缓解或预期用途的特殊考虑时，调整抗扰度测试水平的指南; （3）关于电磁干扰的基本安全和基本性能的风险管理指南; （4）和关于确定抗扰度免疫性通过/未通过标准的指南。 IEC 60601-1-2 Identification of IMMUNITY pass/fail criteria YY0505-2012《医用电气设备 第1-2部分：安全通用要求 并列标准：电磁兼容 要求和试验》 YY 0505 - 2012 Identification of IMMUNITY pass/fail criteria 医疗器械产品标准众多，通标，产品专标，在满足基本的通用标准要求，还需要评估产品是否有适用的专标，然后进行相关补充测试。特别是针对医疗产品的抗扰度测试，新标准会依据产品的风险类别、使用环境，厂家对ME产品的使用及性能范围定义，以及特定产品在标准里面都会有相关的描述以及说明，可能会出现个别产品以及个别现象的评估差异，特别是在不同检验所、不同工程师的情况下。 |
Official Journal of the European Union COMMISSION REGULATION (EC) No 1275/2008o
Official Journal of the European Union COMMISSION REGULATION (EC) No 1275/2008o
工程师具有15年以上的EMC行业从业经验，处理过各类数字模拟复杂高集成度电路经验，不限于几十千伏高压放电与微小人体生理信号。成功处理过笔记本电脑、红外热像仪、脑电心电、血液透析、导航与各类家电等经验。
罗德与施瓦茨公司、是德/安捷伦、EMTest、ETS-Lindgren、泰克及整改用到的各类辅助设备，不限于近场探头、示波器、电桥等仪器设备。现场，还拥有各类EMC物料不限于、磁环、滤波器、电容、电阻、电感、磁珠、铜箔、导电布等。
我们相信您一定遇到过这样、那样的电磁干扰、抗干扰的问题，一筹莫展，找不到骚扰根源、或找不到敏感电路、信号，延误产品上市周期，这时您可以选择我们，我们可以为您提供清晰的解惑与悉心指导，不仅仅是解决问题，还授人以渔。
我们不仅仅仅有EMC测试、EMC整改服务、还有各类EMC器件，可以提供各类EMC合格方案，还具备全球各地区的认证，不限于电磁兼容、安规、无线射频、可靠性与偏门测试等标准法规，甚至定制化测试与验证，可为企业提供一站式服务。
Index of defined terms used in this collateral standard
ACCESSORY ............................................................................. IEC 60601-1:2005+A1:2012, 3.3
ACCOMPANYING DOCUMENT........................................................ IEC 60601-1:2005+A1:2012, 3.4
ALARM CONDITION ................................................................. IEC 60601-1:2005+A1:2012, 3.141
ALARM LIMIT .......................................................................... IEC 60601-1-8:2006+A1:2012, 3.3
ALARM SIGNAL ...................................................................... IEC 60601-1:2005+A1:2012, 3.142
ALARM SYSTEM ..................................................................... IEC 60601-1:2005+A1:2012, 3.143
APPLIED PART ........................................................................... IEC 60601-1:2005+A1:2012, 3.8
BASIC SAFETY ......................................................................... IEC 60601-1:2005+A1:2012, 3.10
CLASS II ................................................................................. IEC 60601-1:2005+A1:2012, 3.14
CLEARLY LEGIBLE .................................................................... IEC 60601-1:2005+A1:2012, 3.15
EFFECTIVE RADIATED POWER (ERP) ........................................................................................ 3.1
ELECTROMAGNETIC COMPATIBILITY (EMC) ............................................................................... 3.2
ELECTROMAGNETIC DISTURBANCE (EM DISTURBANCE) ................................................................ 3.3
(ELECTROMAGNETIC) EMISSION ............................................................................................... 3.4
ELECTROMAGNETIC ENVIRONMENT (EM ENVIRONMENT)............................................................... 3.5
ELECTROSTATIC DISCHARGE (ESD) ......................................................................................... 3.6
EMERGENCY MEDICAL SERVICES ENVIRONMENT ....................................... IEC 60601-1-12:—13) 3.1
ENCLOSURE ............................................................................ IEC 60601-1:2005+A1:2012, 3.26
ENCLOSURE PORT .................................................................................................................. 3.7
ESSENTIAL PERFORMANCE ....................................................... IEC 60601-1:2005+A1:2012, 3.27
EXPECTED SERVICE LIFE .......................................................... IEC 60601-1:2005+A1:2012, 3.28
FALSE NEGATIVE ALARM CONDITION ........................................ IEC 60601-1-8:2006+A1:2012, 3.20
FALSE POSITIVE ALARM CONDITION ......................................... IEC 60601-1-8:2006+A1:2012, 3.21
FIXED ..................................................................................... IEC 60601-1:2005+A1:2012, 3.30
HAND-HELD ............................................................................ IEC 60601-1:2005+A1:2012, 3.37
HARM ..................................................................................... IEC 60601-1:2005+A1:2012, 3.38
HAZARD.................................................................................. IEC 60601-1:2005+A1:2012, 3.39
HAZARDOUS SITUATION ............................................................ IEC 60601-1:2005+A1:2012, 3.40
HF (HIGH FREQUENCY) ................................................................ IEC 60601-2-2:2009, 201.3.218
HF SURGICAL ACCESSORY ........................................................... IEC 60601-2-2:2009, 201.3.221
HF SURGICAL EQUIPMENT ............................................................ IEC 60601-2-2:2009, 201.3.222
HIGH PRIORITY ..................................................................... IEC 60601-1-8:2006+A1:2012, 3.22
HOME HEALTHCARE ENVIRONMENT ........................................................ IEC 60601-1-11:2010, 3.2
IMMUNITY (TO A DISTURBANCE) ................................................................................................ 3.8
IMMUNITY TEST LEVEL ............................................................................................................. 3.9
INFORMATION TECHNOLOGY EQUIPMENT (ITE) ......................................................................... 3.10
INTENDED USE ........................................................................ IEC 60601-1:2005+A1:2012, 3.44
INTERNALLY POWERED ............................................................. IEC 60601-1:2005+A1:2012, 3.46
INTERMITTENT MODE ............................................................................................................ 3.11
LARGE ME EQUIPMENT .......................................................................................................... 3.12
LARGE ME SYSTEM ............................................................................................................... 3.13
LOW VOLTAGE ...................................................................................................................... 3.14
MANUFACTURER ...................................................................... IEC 60601-1:2005+A1:2012, 3.55
ME EQUIPMENT ....................................................................... IEC 60601-1:2005+A1:2012, 3.63
ME SYSTEM ............................................................................ IEC 60601-1:2005+A1:2012, 3.64
MEDIUM PRIORITY ................................................................. IEC 60601-1-8:2006+A1:2012, 3.28
NOMINAL ................................................................................ IEC 60601-1:2005+A1:2012, 3.69
NORMAL CONDITION ................................................................. IEC 60601-1:2005+A1:2012, 3.70
NORMAL USE ........................................................................... IEC 60601-1:2005+A1:2012, 3.71
OBJECTIVE EVIDENCE .............................................................. IEC 60601-1:2005+A1:2012, 3.72
OPERATOR ............................................................................. IEC 60601-1:2005+A1:2012, 3.73
PATIENT ................................................................................. IEC 60601-1:2005+A1:2012, 3.76
PATIENT CONNECTION .............................................................. IEC 60601-1:2005+A1:2012, 3.78
PATIENT-COUPLED ................................................................................................................ 3.15
PATIENT COUPLING POINT...................................................................................................... 3.16
PERMANENTLY INSTALLED ........................................................ IEC 60601-1:2005+A1:2012, 3.84
PORT .................................................................................................................................. 3.17
PORTABLE .............................................................................. IEC 60601-1:2005+A1:2012, 3.85
POTENTIAL EQUALIZATION CONDUCTOR ...................................... IEC 60601-1:2005+A1:2012, 3.86
POWER SUPPLY CORD .............................................................. IEC 60601-1:2005+A1:2012, 3.87
PROCESS ............................................................................... IEC 60601-1:2005+A1:2012, 3.89
PROTECTIVE EARTH CONDUCTOR .............................................. IEC 60601-1:2005+A1:2012, 3.93
PUBLIC MAINS NETWORK ....................................................................................................... 3.18
RADIO FREQUENCY (RF) ....................................................................................................... 3.19
RATED ................................................................................... IEC 60601-1:2005+A1:2012, 3.97
RESIDUAL RISK ...................................................................... IEC 60601-1:2005+A1:2012, 3.100
RESPONSIBLE ORGANIZATION ................................................. IEC 60601-1:2005+A1:2012, 3.101
RISK .................................................................................... IEC 60601-1:2005+A1:2012, 3.102
RISK ANALYSIS ...................................................................... IEC 60601-1:2005+A1:2012, 3.103
RISK ASSESSMENT ................................................................. IEC 60601-1:2005+A1:2012, 3.104
RISK CONTROL ...................................................................... IEC 60601-1:2005+A1:2012, 3.105
RISK EVALUATION .................................................................. IEC 60601-1:2005+A1:2012, 3.106
RISK MANAGEMENT ................................................................ IEC 60601-1:2005+A1:2012, 3.107
RISK MANAGEMENT FILE ......................................................... IEC 60601-1:2005+A1:2012, 3.108
SEVERITY ............................................................................. IEC 60601-1:2005+A1:2012, 3.114
SHORT-WAVE THERAPY EQUIPMENT .............................................. IEC 60601-2-3:2012, 201.3.206
SIP/SOP (SIGNAL INPUT/OUTPUT PART) .................................... IEC 60601-1:2005+A1:2012, 3.115
SPECIAL ENVIRONMENT ......................................................................................................... 3.20
TYPE TEST ............................................................................ IEC 60601-1:2005+A1:2012, 3.135
VERIFICATION ....................................................................... IEC 60601-1:2005+A1:2012, 3.138
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Table 9 – ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Table 9 – ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Table 8 – Signal input/output parts PORT
Table 8 – Signal input-output parts PORT
Table 7 – * PATIENT coupling PORT
Table 7 – PATIENT coupling PORT
Table 6 – Input d.c. power PORT
Table 6 – Input d.c. power PORT
Table 5 – * Input a.c. power PORT (1 of 2)
Table 5 – Input a.c. power PORT (1 of 2)
Table 5 (2 of 2)
Table 4 – * ENCLOSURE PORT
Table 4 – ENCLOSURE PORT
Figure 3 – Examples of environments of INTENDED USE
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专业的医疗设施环境 - Professional healthcare facility environment
医生办公室、牙科诊所、诊所、有限护理设施、独立手术中心、独立分娩中心、多种治疗设施、医院（急诊室、病房、重症监护室、手术室，HF 手术设备附近除外，用于磁共振成像的 ME 系统的射频屏蔽室外）
家庭保健环境 - HOME HEALTHCARE ENVIRONMENT
餐馆、咖啡馆、商店、商店、市场、学校、教堂、图书馆、户外（街道、人行道、公园）、住所（住宅、家庭、疗养院）、车辆（汽车、公共汽车、火车、船、飞机、直升机）、火车站、汽车站、机场、酒店、旅馆、养老院、博物馆、剧院
特殊环境 - SPECIAL ENVIRONMENT军事区（潜艇、雷达装置附近、武器控制系统附近）、重工业区（发电厂、钢铁和造纸厂、铸造厂、汽车和电器制造、冶炼和采矿作业、石油和天然气精炼厂）、配备高功率 ME 设备（HF 手术设备、短波治疗设备）的医疗区域，ME 系统的射频屏蔽室内 用于磁共振成像）
Although healthcare professionals are present in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, the ELECTROMAGNETIC ENVIRONMENT is similar to that of the HOME HEALTHCARE ENVIRONMENT. Therefore, for the purposes of this collateral standard, the EMISSIONS and IMMUNITY requirements of the HOME HEALTHCARE ENVIRONMENT apply to ME EQUIPMENT and ME SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT. An example of such a location is an ambulance.
尽管急救医疗服务环境中有医疗专业人员，但电磁环境与家庭医疗环境类似。因此，就本附带标准而言，家庭医疗环境的排放和免疫要求适用于用于紧急医疗服务环境的医用电气设备和医用电气系统。救护车就是这样一个例子。
Figure 3 – Examples of environments of INTENDED USE
Figure 3 – Examples of environments of INTENDED USE
专业的医疗设施环境 - Professional healthcare facility environment
医生办公室、牙科诊所、诊所、有限护理设施、独立手术中心、独立分娩中心、多种治疗设施、医院（急诊室、病房、重症监护室、手术室，HF 手术设备附近除外，用于磁共振成像的 ME 系统的射频屏蔽室外）
家庭保健环境 - HOME HEALTHCARE ENVIRONMENT
餐馆、咖啡馆、商店、商店、市场、学校、教堂、图书馆、户外（街道、人行道、公园）、住所（住宅、家庭、疗养院）、车辆（汽车、公共汽车、火车、船、飞机、直升机）、火车站、汽车站、机场、酒店、旅馆、养老院、博物馆、剧院
特殊环境 - SPECIAL ENVIRONMENT军事区（潜艇、雷达装置附近、武器控制系统附近）、重工业区（发电厂、钢铁和造纸厂、铸造厂、汽车和电器制造、冶炼和采矿作业、石油和天然气精炼厂）、配备高功率 ME 设备（HF 手术设备、短波治疗设备）的医疗区域，ME 系统的射频屏蔽室内 用于磁共振成像）
Although healthcare professionals are present in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, the ELECTROMAGNETIC ENVIRONMENT is similar to that of the HOME HEALTHCARE ENVIRONMENT. Therefore, for the purposes of this collateral standard, the EMISSIONS and IMMUNITY requirements of the HOME HEALTHCARE ENVIRONMENT apply to ME EQUIPMENT and ME SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT. An example of such a location is an ambulance.
尽管急救医疗服务环境中有医疗专业人员，但电磁环境与家庭医疗环境类似。因此，就本附带标准而言，家庭医疗环境的排放和免疫要求适用于用于紧急医疗服务环境的医用电气设备和医用电气系统。救护车就是这样一个例子。