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CSA C22.2 No. 60601.2.4 : 2012 : R2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
Available format(s)

Hardcopy , PDF

Superseded date

25-09-2021

Language(s)

English, English - French

Published date

01-01-2016

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 Charging time
201.102 Internal electrical power source
201.103 Endurance
201.104 Synchronizer
201.105 Recovery of the MONITOR and/or ECG input
        after defibrillation
201.106 Disturbance to the MONITOR from charging
        or internal discharging
201.107 Requirements for RHYTHM RECOGNITION DETECTOR
201.108 DEFIBRILLATOR ELECTRODES
201.109 External pacing (U.S.)
202 Electromagnetic compatibility - Requirements and tests
Annexes
Annex C (informative) - Guide to marking and labeling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Mapping between the elements of
         the second edition of IEC 60601-2-4 and
         IEC 60601-2-4:2010
Bibliography
Index of defined terms used in this particular standard

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.

DevelopmentNote
Supersedes CSA C22.2.601.2.4. (02/2006)
DocumentType
Standard
Pages
182
ProductNote
Reconfirmed EN THIS STANDARD ALSO REFERS TO CAN/CSA-C22.2 No. 60601-1-2,CAN/CSA-IEC 61000-4-2
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
AAMI DF39 : 1ED 93 AUTOMATIC EXTERNAL DEFIBRILLATORS AND REMOTE-CONTROL DEFIBRILLATORS

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