• I.S. EN 60601-2-57:2011

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-57: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NON-LASER LIGHT SOURCE EQUIPMENT INTENDED FOR THERAPEUTIC, DIAGNOSTIC, MONITORING AND COSMETIC/AESTHETIC USE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2011

    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)

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and
           documents
    201.8 Protection against electrical HAZARDS from
           ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of
           ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
           radiation HAZARDS
    201.11 Protection against excessive temperatures
           and other HAZARDS
    201.12 Accuracy of controls and instruments and
           protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
           (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT
           and ME SYSTEMS
    Annexes
    Annex AA (informative) - Particular guidance and
             rationale
    Annex BB (informative) - Exposure limit values
    Annex CC (informative) - Protective eyewear for LS
             EQUIPMENT
    Annex DD (informative) - Summary of MANUFACTURER'S
             requirements
    Annex EE (informative) - Symbols on marking
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    Applicable to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).

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

    Committee TC 76
    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    BS 8497-1:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Specification for products
    ISO 3864-2:2016 Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety labels
    EN 60947-3:2009/A2:2015 LOW-VOLTAGE SWITCHGEAR AND CONTROLGEAR - PART 3: SWITCHES, DISCONNECTORS, SWITCH-DISCONNECTORS AND FUSE-COMBINATION UNITS (IEC 60947-3:2008/A2:2015)
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    BS 8497-2:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Guidance on use
    IEC 60947-3:2008+AMD1:2012+AMD2:2015 CSV Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units
    EN 62471:2008 Photobiological safety of lamps and lamp systems
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