CSA C22.2 No. 60601.1 : 2014

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

Available format(s): Hardcopy, PDF

Superseded date: 28-01-2022

Language(s): English

Published date: 01-01-2014

Publisher: Canadian Standards Association

Table of Contents - (Show below) - (Hide below)

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
   ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection against
   hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex E (informative) - Examples of the connection of the
        measuring device (MD) for measurement of the
        PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex F (informative) - Suitable measuring supply circuits
Annex G (normative) - Protection against HAZARDS of ignition
        of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
        LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
        diagrams
Annex L (normative) - Insulated winding wires for use
        without interleaved insulation
Annex M (normative) - Reduction of pollution degrees
Bibliography
INDEX
INDEX OF ABBREVIATIONS AND ACRONYMS

Abstract - (Show below) - (Hide below)

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be used in accordance with CSA C22.1 (Canadian Electrical Code, Part I) and CSA Z32.

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes CSA C22.2.601.1. (03/2008)
Document Type	Standard
ISBN
Pages
Published
Publisher	Canadian Standards Association
Status	Superseded
Superseded By	CAN/CSA-C22.2 NO. 60601-1:14 (R2018)
Supersedes	CSA C22.2 No. 60601.1 : 2008 : R2013

Standards Referenced By This Book - (Show below) - (Hide below)

CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CSA Z8835.3 : 2008	INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
CSA Z23747 : 2008 : R2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
CSA Z10535.1 : 2015	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
CSA C22.2 No. 60601-2-6 : 2014 : R2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT
CSA Z10651-5 : 2008 : R2013	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CAN/CSA-C22.2 NO. 80601-2-72:17	Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
CSA Z8185 : 2008(R2013)	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
CSA Z8185 : 2008	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
C22.2 NO. 269.3-17	Surge protective devices - Type 3 - Cord connected, direct plug-in and receptacle type
CSA Z902 : 2010 : R2015	BLOOD AND BLOOD COMPONENTS
CSA Z17510.1 : 2010	SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
CSA Z10651-5 : 2008 : INC : UPD 1 : 2011	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
Z364.6-17	Quality management for kidney dialysis providers
CSA C22.2 No. 60601.1.2 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
CSA C22.2 No. 60601.2.26 : 2014(R2018)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
CSA C22.2 No. 60601-2-19 : 2009 : R2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
CSA C22.2 No. 62368-1 : 2014	AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
CSA Z10524-3 : 2012 : R2017	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CSA C22.2 No. 60065 : 2016	AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS
CSA SPE 3000 : 2015	MODEL CODE FOR THE FIELD EVALUATION OF MEDICAL ELECTRICAL EQUIPMENT AND SYSTEMS
CSA C22.2 No. 60601-2-21 : 2010FR	MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
CSA C22.2 No. 60601-1-12 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
CSA C22.2 No. 60601.2.47 : 2014(R2018)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
CSA Z17510.2 : 2009	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
CSA C22.2 No. 80601-2-12 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
CSA C22.2 No. 60601-2-21 : 2010 : INC : COR 1 : 2017 : R201400	MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
CSA C22.2 No. 60601-1-11 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
CSA Z18779 : 2008 : R2013	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
CSA Z364.2.1:2013	MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT
CAN/CSA-Z7376:12 (R2017)	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations)
CSA C22.2 No. 60601-2-6 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT
CSA Z8835.2 : 2008	INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS
CSA C22.2 No. 80601-2-12 : 2012(R2017)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
CSA Z10524-3 : 2012	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CSA Z23747:2008	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
CSA C22.2 No. 269 PACKAGE : 2017	CONSISTS OF C22.2 NO. 269.1-17 - SURGE PROTECTIVE DEVICES - TYPE 1 - PERMANENTLY CONNECTED; C22.2 NO. 269.2-17 - SURGE PROTECTIVE DEVICES - TYPE 2 - PERMANENTLY CONNECTED; C22.2 NO. 269.3-17 - SURGE PROTECTIVE DEVICES - TYPE 3 - CORD CONNECTED, DIRECT PLUG-IN AND RECEPTACLE TYPE; C22.2 NO. 269.4-17 - SURGE PROTECTIVE DEVICES - TYPE 4 - COMPONENT ASSEMBLIES AND C22.2 NO. 269.5-17 - SURGE
CSA Z10651-5 : 2008	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CSA Z902 : 2010 : INC : UPD 1 : 2012	BLOOD AND BLOOD COMPONENTS
CSA Z7376 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
CSA Z32 : 2015	ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
CSA Z10651-5 : 2008 : R2018	Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
CSA C22.2 No. 60601-2-21 : 2010 : R2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
CSA Z902 : 2010 : INC : UPD 2 : 2012	BLOOD AND BLOOD COMPONENTS
CSA Z902 : 2010 : INC : UPD 1 : 2012 : FR	BLOOD AND BLOOD COMPONENTS
CSA C22.2 No. 60601-2-19 : 2009 : INC : COR 1 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
CSA C22.2 No. 80601-2-69 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
CAN/CSA-C22.2 NO. 80601-2-67:17	Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations)
CAN/CSA-C22.2 NO. 80601-2-71:17	Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Adopted IEC 80601-2-71:2015, first edition, 2015-06, with Canadian deviations)
Z10535.2-17	Lifts for the transfer of persons - Installation, use, and maintenance
CAN/CSA-C22.2 NO. 60601-2-19-09 (R2018)	Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02) \| Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau- nés (norme CEI 60601-2-19:2009 adoptée, deuxième édition, 2009-02)
CAN/CSA-C22.2 NO. 80601-2-70:17	Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
Z364.2.1-13 (R2018)	Monitoring systems for hemodialysis equipment
CSA Z18779 : 2008	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
CSA C22.2 No. 60601.2.16 : 2014(R2019)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
CSA Z902 : 2010	BLOOD AND BLOOD COMPONENTS
CSA Z305.13 : 2013(R2018)	PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
CSA C22.2 No. 60601.2.40 : 2017	MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
CSA C22.2 No. 60601-2-21 : 2010	MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS

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IEC 61672-2:2013+AMD1:2017 CSV	Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 61558-2-1:2007	Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications
IEC 60245-1:2003+AMD1:2007 CSV	Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
CSA Z305.13 : 2013(R2018)	PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
IEC TS 60479-1:2005+AMD1:2016 CSV	Effects of current on human beings and livestock - Part 1: Generalaspects
CGA V 1 : 2013	STANDARD FOR COMPRESSED GAS CYLINDER VALVE OUTLET AND INLET CONNECTIONS
IEC 60384-14:2013+AMD1:2016 CSV	Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
UL 1439:5ED 2015-04	Tests for Sharpness of Edges on Equipment
IEC 60364-7-710:2002	Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60127-6:2014	Miniature fuses - Part 6: Fuse-holders for miniature fuse-links
IEC 60050-195:1998	International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock
C22.1-15	Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
ASME PTC25 : 2014	PRESSURE RELIEF DEVICES
CSA C22.2 No. 49 : 2014	FLEXIBLE CORDS AND CABLES
IEC 60364-4-41:2005+AMD1:2017 CSV	Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock
IEC 60073:2002	Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
IEC 61558-2-4:2009	Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers
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ISO 2882:1979	Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits
ISO 9614-1:1993	Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
IEC 60050-151:2001	International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices
IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV	Plugs and socket-outlets for household and similar purposes - Part1: General requirements
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ISO 15001:2010	Anaesthetic and respiratory equipment Compatibility with oxygen
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