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

 

Project

Reference EN 60601-2-47:2001
Title Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
Project Number 7365
Abstract/Scope Specifies the particular safety requirements for ambulatory electrocardiographic systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2001-10-26
Current Stage code deadline 2002-07-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher BC/CLC/93-01

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-47:2001 (EQV)
ICS 11.040.55 - Diagnostic equipment
Keywords Medical equipment; Ambulatory; Electrocardiograph; Essential performance; Safety
Note EN following parallel vote
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2001-10-26 2002-07-01 export to doc file  EN
5099 2001-10-01 2002-02-01  
5061 2001-08-28 2001-10-01  
5020 2001-03-30 2001-06-01  
4099 2001-03-27 2001-03-30  
4020 2000-02-04 2000-07-17  
3099 2000-01-31 2000-02-04  
1000 1997-05-23 1998-04-30  
1000 1995-12-15    

Implementation Dates

date of Ratification (DOR) (1) 2001-10-01
date of Availability (DAV) (2) 2001-10-26
date of Announcement (DOA) (3) 2002-01-01
date of Publication (DOP) (4) 2002-07-01
date of Withdrawal (DOW) (5) 2004-10-01

Relations

Supersedes  
Superseded by FprEN 60601-2-47:2011
Normative reference (6) EN 60529:1991
corr. May 1993
EN 60601-1:1990
corr. July 1994
A11:1993
A12:1993
A13:1996
EN 60601-2-25:1995
EN 60601-2-27:1994

(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.