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CENELEC
EN 80601-2-60:2015

EN 80601-2-60:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

08-04-2020

Superseded by

EN IEC 80601-2-60:2020

Published date

22-05-2015

Publisher

European Committee for Standards - Electrical

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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

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.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

DIN 19403:2016-08 DENTISTRY - MULTIFUNCTION HANDPIECES

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 (ISO 1942:2009, Corrected version 2010-03-01)
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 7785-2:1995)
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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