I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT
Hardcopy , PDF
02-05-2020
English
01-01-2015
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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.
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 80601-2-60:2015 | 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) |
| 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 |
| 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 |
| 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 |
| 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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