医疗器械 IEC 60601-1-2 与 YY0505抗扰度简述

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：

• 根据预期用途的环境规定的抗扰度测试等级，根据与IEC 60601-1-11协调的位置进行分类：专业医疗设施环境，家庭医疗保健环境和特殊环境;
  

当便携式RF通信设备靠近医疗电气设备使用时，根据第三版规定的抗扰度测试水平，建议测试和测试水平的规范，以提高医疗电气设备和医疗电气系统的安全性;

• 根据医疗电气设备或医疗电气系统的端口规定的抗扰度试验和抗扰度试验水平;
  

• 基于在预期使用环境中可合理预见的最大电磁干扰水平的抗扰度测试水平的规范，导致一些免疫测试水平高于前一版本; 和更好地协调基本安全和基本性能的风险概念，包括删除定义的“生命支持”一词。此新版本包括以下主要内容：
  

     （1）确定特殊环境的抗扰度测试水平的指南;
     （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。

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)