• 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

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    Published date:  08-04-2011

    Publisher:  European Committee for Standards - Electrical

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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)

    IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

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

    Committee CLC/TC 76
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Current

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

    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    BS EN 60601-2-18:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of endoscopic equipment
    UNE-EN 16372:2015 Aesthetic surgery services
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    BS EN 80601-2-60:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment
    CEI EN 80601-2-60 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT
    EN 80601-2-60:2015 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    UNE-EN 60601-2-18:2016 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    EN 16372:2014 Aesthetic surgery services
    BS EN 16372:2014 Aesthetic surgery services
    I.S. EN 80601-2-60:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    EN 60601-2-18:2015 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

    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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