IEC 60601-2-4:2010+AMD1:2018 CSV
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French
28-02-2018
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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 |
| 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 |
| I.S. EN 60601- 1:2006&A1:2013&A12:2014&A2:2021 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020) |
| 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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