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  • IEC 80601-2-60:2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-12-2021

    Language(s):  English - French

    Published date:  20-02-2012

    Publisher:  International Electrotechnical Committee

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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

    Abstract - (Show below) - (Hide below)

    IEC 80601-2-60:2012 applies to the basic safety and essential performance of Dental Units, Dental Patient Chairs, Dental Handpieces and Dental Operating Lights. Excluded are amalgamators, sterilizers and dental X-ray equipment.

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

    Development Note Stability Date: 2015. (10/2012)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

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

    16/30310674 DC : 0 BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS
    17/30332162 DC : 0 BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    I.S. EN ISO 18397:2016 DENTISTRY - POWERED SCALER (ISO 18397:2016)
    13/30245306 DC : 0 BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS
    DIN EN ISO 18397:2016-09 DENTISTRY - POWERED SCALER (ISO 18397:2016)
    ISO 18397:2016 Dentistry Powered scaler
    DIN EN ISO 9680 E : 2015 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
    EN ISO 9680:2014 Dentistry - Operating lights (ISO 9680:2014)
    14/30284310 DC : 0 BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS
    DIN EN ISO 10650 E : 2016 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
    PD IEC/TR 60601-4-3:2015 Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    NF EN ISO 18397 : 2016 DENTISTRY - POWERED SCALER
    I.S. EN ISO 14457:2017 DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
    UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    UNE-EN ISO 14457:2013 Dentistry - Handpieces and motors (ISO 14457:2012)
    DIN EN ISO 9680:2015-02 Dentistry - Operating lights (ISO 9680:2014)
    I.S. EN ISO 9680:2014 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
    BS EN ISO 10650:2015 Dentistry. Powered polymerization activators
    DIN EN ISO 18397 E : 2016 DENTISTRY - POWERED SCALER (ISO 18397:2016)
    I.S. EN ISO 20608:2018 DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018)
    BS EN ISO 18397:2016 Dentistry. Powered scaler
    EN ISO 10650:2015 Dentistry - Powered polymerization activators (ISO 10650:2015)
    I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    BS EN ISO 7494-1:2011 Dentistry. Dental units General requirements and test methods
    DIN EN ISO 10650:2016-02 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
    EN ISO 20608:2018 Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
    BS EN ISO 9680:2014 Dentistry. Operating lights
    ISO 9680:2014 Dentistry Operating lights
    UNI EN ISO 9680 : 2015 DENTISTRY - OPERATING LIGHTS
    EN ISO 18397:2016 Dentistry - Powered scaler (ISO 18397:2016)
    I.S. EN ISO 10650:2015 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
    14/30273278 DC : 0 BS EN ISO 18397 - DENTISTRY - POWERED SCALER
    DIN 19403:2016-08 DENTISTRY - MULTIFUNCTION HANDPIECES
    ISO 10650:2015 Dentistry Powered polymerization activators
    UNI EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    UNE-EN ISO 10650:2016 Dentistry - Powered polymerization activators (ISO 10650:2015)
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    EN ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    ISO 20608:2018 Dentistry — Powder jet handpieces and powders
    ONORM EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    EN ISO 14457:2017 Dentistry - Handpieces and motors (ISO 14457:2017)
    ISO 14457:2017 Dentistry — Handpieces and motors

    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
    ISO 21530:2004 Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants
    ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
    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
    ISO 7494-2:2015 Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems
    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 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
    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
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    View more information

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