• PD ISO/TR 21730:2007

    Current The latest, up-to-date edition.

    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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-03-2007

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Terms, definitions and abbreviated terms
      2.1 Terms and definitions
      2.2 Abbreviated terms
    3 Current status of management of electromagnetic
      interference
      3.1 Mobile wireless equipment in healthcare facilities
      3.2 The risk of patient harm due to EMI
      3.3 Existing relevant standards and recommendations
      3.4 EMC with medical devices and minimization of EMI risk
    4 Recommendations
      4.1 General recommendations
      4.2 Responsibility within healthcare facilities
      4.3 Inventory within healthcare facilities
      4.4 Testing within healthcare facilities
      4.5 Controlled use within healthcare facilities
      4.6 Non-controlled use within healthcare facilities
      4.7 RF emissions from network sources
      4.8 Medical devices within healthcare facilities
    Annex A (informative) RF technologies
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI).

    Scope - (Show below) - (Hide below)

    This Technical Report provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given recognize the different resources, needs, concerns and environments of healthcare organizations around the world, and provide detailed management guidelines for healthcare organizations that desire full deployment of mobile wireless communication and computing technology throughout their facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organizations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce.

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    Committee IST/35
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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
    1989/336/EEC : 1989 COUNCIL DIRECTIVE OF 3 MAY 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMAGNETIC COMPATIBILITY
    IEEE 802.15.4-2011 IEEE Standard for Local and metropolitan area networks--Part 15.4: Low-Rate Wireless Personal Area Networks (LR-WPANs)
    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
    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
    ASTM F 2401 : 2016 : REDLINE Standard Practice for Security Checkpoint Metal Detector Screening of Persons 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
    ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    ISO/IEC 8802-11:2005 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
    119999/5/EC : 1999 DIRECTIVE 1999/5/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 9 MARCH 1999 ON RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT AND THE MUTUAL RECOGNITION OF THEIR CONFORMITY
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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