International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference EN 60601-2-4:2011
Title Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Project Number 22219
Abstract/Scope 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.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2011-08-19
Current Stage code deadline 2011-10-12
Deadline date for vote  

Legal

Directive(s) MDD pending (93/42/EEC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-4:2010 (EQV)
ICS 11.040.10 - Anaesthetic, respiratory and reanimation equipment
Keywords Medical; safety; Cardiac; Defibrillator
Note Supersedes EN 60601-2-4:2003
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2011-08-19 2011-10-12 export to doc file  EN  FR  DE
5099 2011-01-12 2011-02-09  
5060 2010-10-25 2010-11-08 export to doc file  EN
5020 2010-08-20 2010-10-22  
3090 2010-03-12 2010-05-31  
5060 2009-07-06 2009-07-20 export to doc file  EN
5020 2009-01-30 2009-07-03  
1090 2009-01-27 2009-01-30  

Implementation Dates

date of Ratification (DOR) (1) 2011-01-12
date of Availability (DAV) (2) 2011-08-19
date of Announcement (DOA) (3) 2011-04-12
date of Publication (DOP) (4) 2012-04-12
date of Withdrawal (DOW) (5) 2014-01-12

Relations

Supersedes EN 60601-2-4:2003
Superseded by  
Normative reference (6) ISO 15223-1:2007
EN 60601-1-2:2007
corr. March 2010
EN 61000-4-2

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.