IEC 80601-2-60:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
31-12-2021
English - French
20-02-2012
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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
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.
| DevelopmentNote |
Stability Date: 2015. (10/2012)
|
| DocumentType |
Standard
|
| Pages |
67
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM OVE EN 80601-2-60 : 2016 | Identical |
| NF EN 80601-2-60 : 2015 | Identical |
| NBN EN 80601-2-60 : 2015 | Identical |
| NEN EN IEC 80601-2-60 : 2015 | Identical |
| PN EN 80601-2-60 : 2015 | Identical |
| VDE 0750-2-60 : 2016 | Identical |
| DIN EN 80601-2-60 : 2016 | Identical |
| BS EN 80601-2-60:2015 | Identical |
| CEI EN 80601-2-60 : 2016 | Identical |
| EN 80601-2-60:2015 | Identical |
| SN EN IEC 80601-2-60:2020 | Identical |
| SN EN 80601-2-60:2015 | Identical |
| UNE-EN 80601-2-60:2015 | Identical |
| PNE-FprEN 80601-2-60 | Identical |
| 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 |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| 14/30284310 DC : 0 | BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| 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 |
| 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 |
| 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 |
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