CEI EN 80601-2-60 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
24-01-2019
English
01-01-2016
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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
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Superseded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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