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

 

Project

Reference EN 60601-2-51:2003
Title Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
Project Number 14389
Abstract/Scope Establishes particular requirements, in addition to the requirements of EN 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analysing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analysing electrocardiographs.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2003-07-31
Current Stage code deadline 2003-04-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-51:2003 (EQV)
ICS 11.040.55 - Diagnostic equipment
Keywords Medical equipment; Recording; Analyse; Single/multi channel; Electrocardiograph
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2003-07-31 2003-04-01 export to doc file  EN
5099 2003-04-01 2003-08-01  
5061 2003-02-27 2003-04-01  
5020 2002-12-06 2003-02-07  
4099 2002-12-03 2002-12-06  
4020 2001-03-23 2001-08-24  
3099 2001-03-20 2001-03-23  

Implementation Dates

date of Ratification (DOR) (1) 2003-04-01
date of Availability (DAV) (2) 2003-07-31
date of Announcement (DOA) (3) 2003-07-01
date of Publication (DOP) (4) 2004-02-01
date of Withdrawal (DOW) (5) 2006-04-01

Relations

Supersedes  
Superseded by  
Normative reference (6) IEEE Computer Society Press:1990, 1991, 1992
ANSI/AAMI EC11:1991
CSE working group recommendation:1985
ISO 1000:1992
ENV 1064:1991
EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-4:1996
EN 60601-2-25:1995
A1:1999

(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.