CEI EN 60601-2-4 : 2012
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
Hardcopy , PDF
English
01-01-2012
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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