• I.S. EN 50527-1:2016

    Current The latest, up-to-date edition.

    PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Risk assessment
    5 Equipment at workplaces
    6 Special cases
    7 AIMD-Employees with more than one AIMD
    8 Documentation
    Annex A (normative) - Specific risk assessment
    Annex B (informative) - Documenting the risk assessment
    Annex C (informative) - Specific electromagnetic environments
    Annex D (informative) - Theoretical considerations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    EN 50500 : 2008 AMD 1 2015 MEASUREMENT PROCEDURES OF MAGNETIC FIELD LEVELS GENERATED BY ELECTRONIC AND ELECTRICAL APPARATUS IN THE RAILWAY ENVIRONMENT WITH RESPECT TO HUMAN EXPOSURE
    PREN 50527-2-2 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
    ISO 14708-4:2008 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
    EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
    EN 50413 : 2008 AMD 1 2013 BASIC STANDARD ON MEASUREMENT AND CALCULATION PROCEDURES FOR HUMAN EXPOSURE TO ELECTRIC, MAGNETIC AND ELECTROMAGNETIC FIELDS (0 HZ - 300 GHZ)
    EN 50499:2008 Procedure for the assessment of the exposure of workers to electromagnetic fields
    EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
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