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  • IEEE/ANSI C63.18-2014 REDLINE

    Current The latest, up-to-date edition.

    American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  20-06-2014

    Publisher:  Institute of Electrical & Electronics Engineers

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    Table of Contents - (Show below) - (Hide below)

    1 Overview
    2 Caveats and limitations
    3 Overview of the test
    4 Preparation for testing
    5 Testing
    6 Use of the test results in determining
      minimum separation distances
    7 Test report
    8 Correlation of test results to laboratory
      immunity testing
    9 Use of test results in EMI policies and
      procedures
    Annex A (informative) - EMC standards and
            guidelines containing radiated RF
            immunity requirements that are or
            could be applicable to medical devices
    Annex B (informative) - Characteristics and
            types of RF transmitters
    Annex C (informative) - Alternative RF test
            sources and test methods
    Annex D (informative) - Estimation of incident
            field strength and minimum test distance
            without the use of an E-field meter
    Annex E (informative) - Obtaining appropriate
            experimental licenses
    Annex F (informative) - Recommendations for
            mitigation of EMI in health-care facilities
    Annex G (informative) - Sample test data sheets
    Annex H (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    This recommended practice is a guide to evaluating the electromagnetic immunity of medical devices to radiated radio-frequency (RF) emissions from common RF transmitters (e.g., two-way radios; walkie-talkies; mobile phones; wireless-enabled tablets, e-readers, laptop computers, and similar devices; radio-frequency identification (RFID) readers; networked mp3 players; two-way pagers; and wireless personal digital assistants [PDAs]).

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Institute of Electrical & Electronics Engineers
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment
    CEI EN 61326-2-6 : 2014 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
    AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
    ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
    PD ISO/TR 21730:2007 Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    I.S. EN 61326-2-6:2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV))
    10/30216029 DC : 0 BS EN 61326-2-6 - ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
    IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    IEEE/ANSI C63.15-2010 American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
    PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
    IEEE DRAFT 1073.0.1 : D01J 2006 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - TECHNICAL REPORT - GUIDELINES FOR THE USE OF RF WIRELESS TECHNOLOGY
    EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
    IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEEE/ANSI C63.9-2008 American National Standard for RF Immunity of Audio Office Equipment to General Use Transmitting Devices with Transmitter Power Levels up to 8 Watts
    IEC 61000-6-1 : 3.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-1: GENERIC STANDARDS - IMMUNITY STANDARD FOR RESIDENTIAL, COMMERCIAL AND LIGHT-INDUSTRIAL ENVIRONMENTS
    IEC TR 61000-5-2:1997 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 2: Earthing and cabling
    ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    IEEE/ANSI C63.12-2015 REDLINE American National Standard Recommended Practice for Electromagnetic Compatibility Limits and Test Levels
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEC TR 61000-5-6:2002 Electromagnetic compatibility (EMC) - Part 5-6: Installation and mitigation guidelines - Mitigation of external EM influences
    IEC 61000-6-1:2016 Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments
    IEC TR 61000-5-1:1996 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 1: General considerations - Basic EMC publication
    RTCA DO 294 : C2008 GUIDANCE ON ALLOWING TRANSMITTING PORTABLE ELECTRONIC DEVICES (T-PEDS) ON AIRCRAFT
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