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医疗器械 IEC 60601-1-2 与 YY0505抗扰度简述

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:
  • 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。

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  1. 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

  2. 多多交流分享

  3. Table 9 – ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

    Table 9 – ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

    Table 9 – ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

  4. Table 8 – Signal input/output parts PORT

    Table 8 – Signal input-output parts PORT

    Table 8 – Signal input-output parts PORT

  5. Table 7 – * PATIENT coupling PORT

    Table 7 – PATIENT coupling PORT

    Table 7 – PATIENT coupling PORT

  6. Table 6 – Input d.c. power PORT

    Table 6 – Input d.c. power PORT

    Table 6 – Input d.c. power PORT

  7. Table 5 – * Input a.c. power PORT (1 of 2)

    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 5 (2 of 2)


  8. Table 4 – * ENCLOSURE PORT

    Table 4 – ENCLOSURE PORT

    Table 4 –  ENCLOSURE PORT

  9. Figure 3 – Examples of environments of INTENDED USE

    [attach]5262[/attach]

    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。

  10. Figure 3 – Examples of environments of INTENDED USE

    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。

  11. Intertek.IEC-60601-1-2-4th-edition.pdf (405.2 KB, 下载次数: 0)

  12. IEC 60601-1-2 (4th edition)第三版与第四版对比.pdf (2.86 MB, 下载次数: 0)