• EN 80601-2-60 : 2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT (IEC 80601-2-60:2012)

    Available format(s): 

    Superseded date:  08-04-2020

    Language(s): 

    Published date:  27-05-2015

    Publisher:  European Committee for Standards - Electrical

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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 TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

    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)
    ISO 21530:2004 Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectants
    EN ISO 7494-2:2015 Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
    ISO 13732-1:2006 Ergonomics of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 1: Hot surfaces
    EN ISO 1942:2010 DENTISTRY - VOCABULARY
    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
    ISO 7494-2:2015 Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems
    EN ISO 21530 : 2004 Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)
    EN 61810-7 : 2006 ELECTROMECHANICAL ELEMENTARY RELAYS - PART 7: TEST AND MEASUREMENT PROCEDURES
    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 61810-7:2006 Electromechanical elementary relays - Part 7: Test and measurement procedures
    EN ISO 13732-1:2008 ERGONOMICS OF THE THERMAL ENVIRONMENT - METHODS FOR THE ASSESSMENT OF HUMAN RESPONSES TO CONTACT WITH SURFACES - PART 1: HOT SURFACES (ISO 13732-1:2006)
    EN 563:1994/A1:1999/AC:2000 SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
    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 60664-4:2006/corrigendum:2006 INSULATION COORDINATION FOR EQUIPMENT WITHIN LOW-VOLTAGE SYSTEMS - PART 4: CONSIDERATION OF HIGH-FREQUENCY VOLTAGE STRESS
    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 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 61180-1 : 1994 HIGH-VOLTAGE TEST TECHNIQUES FOR LOW-VOLTAGE EQUIPMENT - PART 1: DEFINITIONS, TEST AND PROCEDURE REQUIREMENTS
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