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BS EN 60601-2-4:2011

BS EN 60601-2-4:2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators

Amended by

BS EN 60601-2-4:2011+A1:2019

Available format(s)

Hardcopy , PDF

Withdrawn date

15-10-2019

Language(s)

English

Published date

30-09-2011

Publisher

British Standards Institution

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
        labelling 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
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EC Directives

Applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.

IEC 60601-2-4:2010 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.

Committee
CH/62/4
DevelopmentNote
Supersedes 00/565643 DC & BS 5724-2.4(1985) (09/2003) Supersedes 06/30160373 DC. (09/2011)
DocumentType
Standard
Pages
80
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
NF EN 60601-2-4 : 2012 Identical
SN EN 60601-2-4 : 2003 Identical
UNE-EN 60601-2-4:2004 Identical
EN 60601-2-4:2011 Identical
IEC 60601-2-4:2010 Identical
DIN EN 60601-2-4 : 2012 Identical
I.S. EN 60601-2-4:2011 Identical

AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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
EN 60601-1-2:2015 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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Hardcopy - English
PDF - English
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