Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Amended by

IEC 60601-2-4:2010/AMD1:2018

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French

Published date

02-28-2018

Publisher

International Electrotechnical Committee

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
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

IEC 60601-2-4:2010+A1:2018 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. This consolidated version consists of the third edition (2010) and its amendment 1 (2018). Therefore, no need to order amendment in addition to this publication.

Committee	TC 62/SC 62D
DevelopmentNote	Also available in CD-ROM format. Stability Date: 2022. (03/2018)
DocumentType	Standard
Pages	327
PublisherName	International Electrotechnical Committee
Status	Current
Supersedes	IEC 60601-2-4:2002 IEC 60601-2-4:2002/COR1:2004

Standards	Relationship
OVE/ONORM EN 60601-2-4 : 2012	Identical
GOST R IEC 60601-2-4 : 2013	Identical
NBN EN 60601 2-4 : 2011	Identical
NF EN 60601-2-4 : 2012	Identical
NEN EN IEC 60601-2-4 : 2011	Identical
PN EN 60601-2-4 : 2011	Identical
DIN EN 60601-2-4 : 2012	Identical
VDE 0750-2-4 : 2012	Identical
IS 13450 : PART 2 : SEC 4 : 2018	Identical
CEI EN 60601-2-4 : 2012	Identical
EN 60601-2-4:2011	Identical

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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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IEC 60601-2-4:2010+AMD1:2018 CSV

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

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