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  • CEI EN 80601-2-60 : 2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-01-2019

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  Comitato Elettrotecnico Italiano

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

    FOREWORD
    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 of 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
    201.101 Cordless HAND-HELD and foot-operated control devices
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    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)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES and DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT.

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

    Committee CT 62
    Development Note Classificazione CEI 62-242. (08/2017) Italian translation of 1ED 2016 Issued on 01/01/2018. (02/2018)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Superseded
    Superseded By

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

    IEC 60601-2-57:2011 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
    IEC 60664-4:2005 Insulation coordination for equipment within low-voltage systems - Part 4: Consideration of high-frequency voltage stress
    EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
    EN ISO 1942:2010 Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01)
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    IEC 61810-1:2015 Electromechanical elementary relays - Part 1: General and safety requirements
    EN 60601-2-57:2011 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
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    IEC 61180-2:1994 High-voltage test techniques for low-voltage equipment - Part 2: Test equipment
    ISO 1942:2009 Dentistry Vocabulary
    EN 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
    ISO 7785-2:1995 Dental handpieces Part 2: Straight and geared angle handpieces
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    IEC 61180-1:1992 High-voltage test techniques for low voltage equipment - Part 1: Definitions, test and procedure requirements
    EN 62471:2008 Photobiological safety of lamps and lamp systems
    EN 61180-2:1994 High-voltage test techniques for low-voltage equipment - Part 2: Test equipment
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
    EN ISO 7785-2:1997 Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
    EN 61180-1:1994 High-voltage test techniques for low-voltage equipment - Part 1: Definitions, test and procedure requirements
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