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CEI EN 80601-2-60 : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

24-01-2019

Language(s)

English

Published date

01-01-2016

Publisher

Comitato Elettrotecnico Italiano

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

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.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-242. (08/2017) Italian translation of 1ED 2016 Issued on 01/01/2018. (02/2018)
DocumentType
Standard
Pages
42
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy

Standards Relationship
EN 80601-2-60:2015 Identical
IEC 80601-2-60:2012 Identical

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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