CSA C22.2 No. 80601-2-60 : 2014

Superseded

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Superseded date

16-11-2019

Language(s)

English

Published date

01-01-2014

Publisher

Canadian Standards Association

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

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	95
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA C22.2 NO. 80601-2-60:14 (R2019)

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
C22.1-15	Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
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