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CEI EN 60601-2-4 : 2012

Current

Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

€263.28
Excluding VAT

FOREWORD
1 Scope, object and related
    standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for
    testing of 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 MECAHNICAL
    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
101 * Charging time
102 Internal electrical power source
103 * Endurance
104 * Synchronizer
105 * Recovery of the MONITOR and/or
    ECG input after defibrillation
106 * Disturbance to the MONITOR from
    charging or internal discharging
107 * Requirements for RHYTHM
    RECOGNITION DETECTOR
108 DEFIBRILLATOR ELECTRODES
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

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

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-13. To be used in conjunction with CEI EN 60601-1:1998-12. (09/2004) NEW CHILD AMD 1 IS ADDED NOW
DocumentType
Standard
Pages
84
ProductNote
NEW CHILD AMD 1 IS ADDED NOW
PublisherName
Comitato Elettrotecnico Italiano
Status
Current
Supersedes

Standards Relationship
EN 60601-2-4:2011 Identical
IEC 60601-2-4:2010 Identical
IEC 60601-2-4:2010+AMD1:2018 CSV 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
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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