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  • AAMI TIR18:2010

    Current The latest, up-to-date edition.

    GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-03-2010

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Foreword
    1 Introduction and scope (ALL)
    2 Definitions and abbreviations (ALL)
    3 General recommendations (ALL)
    4 Assessment of the electromagnetic environment
      in existing facilities (TECH)
    5 Management of the electromagnetic environment
      (TECH, ADMIN, PSRM, MED)
    6 Management of medical devices for EMC (TECH,
      ADMIN, PSRM)
    7 Identification, investigation, and reporting of
      EMI problems (TECH, MED, ADMIN, PSRM)
    8 Site selection, design, and construction of facilities
      (TECH, ADMIN, HCA)
    9 Education and training (ALL)
    Annexes
    A - Principles of electromagnetic energy and interference
        mechanisms (TECH)
    B - Selected case studies in EMI problems (TECH, MED, PSRM)
    C - Model electromagnetic compatibility (EMC) and radiofrequency
        wireless technology policy and guidance for developing EMC
        and wireless policies (ADMIN, PSRM, HCA)
    D - Overview of surveys of electromagnetic environments associated
        with healthcare facilities (TECH)
    E - Example of manufacturer declaration of electrosurgical
        generator meeting IEC 60601-1-2 (TECH, ADMIN, MED)
    F - Bibliography (ALL)

    Abstract - (Show below) - (Hide below)

    Specifies information, guidance, and general recommendations regarding electromagnetic compatibility (EMC) of medical devices and the use of wireless technology in healthcare facilities to promote patient safety.

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

    Committee EM
    Document Type Technical Report
    Publisher Association for the Advancement of Medical Instrumentation
    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
    CSA ISO/IEC TR 20017:14 (R2019) Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15)
    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
    ANSI/AAMI/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
    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
    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
    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
    AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS
    ISO/IEC TR 20017:2011 Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
    IEEE/ANSI C63.18-2014 REDLINE 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
    IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    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))
    IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
    IEEE C95.7-2014 IEEE Recommended Practice for Radio Frequency Safety Programs, 3 kHz to 300 GHz
    12/30159217 DC : 0 BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
    CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS

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

    EN 302 195-1 : 1.1.1 ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); RADIO EQUIPMENT IN THE FREQUENCY RANGE 9 KHZ TO 315 KHZ FOR ULTRA LOW POWER ACTIVE MEDICAL IMPLANTS (ULP-AMI) AND ACCESSORIES; PART 1: TECHNICAL CHARACTERISTICS AND TEST METHODS
    AAMI PC69 : 2007
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    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
    IEC 61326-2-3:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-3: Particular requirements - Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning
    IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
    IEEE/ANSI C63.18-2014 REDLINE 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
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    IEEE 802.11-2016 IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
    IEC TR 61000-5-2:1997 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 2: Earthing and cabling
    ISO/TR 16056-1:2004 Health informatics Interoperability of telehealth systems and networks Part 1: Introduction and definitions
    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 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
    CISPR 22:2008 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement
    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
    ISO/TR 16056-2:2004 Health informatics Interoperability of telehealth systems and networks Part 2: Real-time systems
    ESD S20.20 : 2014 PROTECTION OF ELECTRICAL AND ELECTRONIC PARTS, ASSEMBLIES AND EQUIPMENT (EXCLUDING ELECTRICALLY INITIATED EXPLOSIVE DEVICES)
    IEEE/ANSI C63.14-2014 REDLINE American National Standard Dictionary of Electromagnetic Compatibility (EMC) including Electromagnetic Environmental Effects (E3)
    MIL-STD-461 Revision G:2015 REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    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 61000-3-3:2013 RLV Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
    IEEE 802.16-2012 IEEE Standard for Air Interface for Broadband Wireless Access Systems
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    IEC 61326-2-2:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-2: Particular requirements - Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems
    IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION
    ISO/TR 18307:2001 Health informatics Interoperability and compatibility in messaging and communication standards Key characteristics
    IEC 61326-2-1:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-1: Particular requirements - Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
    IEEE/ANSI C63.19-2011 REDLINE American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
    IEC TR 61000-5-1:1996 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 1: General considerations - Basic EMC publication
    IEC 61000-3-2 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE)
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