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



Reference EN 45502-2-1:2003
Title Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Project Number 7407


Current Stage code 6060
Current Stage code date 2003-12-22
Current Stage code deadline 2004-09-01
Deadline date for vote  


Directive(s) AIMD (90/385/EEC)
Mandate(s) M/432
Order Voucher BC/CLC/02-89


IEC Technical Body IEC/SC 62D
Reference Document  
ICS 11.040.40 - Implants for surgery, prosthetics and orthotics
Keywords Medical device; Implantable; Safety; Bradyarrhythmia; Pacemaker
Note EN 45502-2-1:2003 & EN 45502-2-2 supersede EN 50061:1988 + A1:1995
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2003-12-22 2004-09-01 export to doc file  EN
5099 2003-09-01 2004-01-01  
5061 2003-06-24 2003-09-01  
5020 2003-01-17 2003-03-21  
3090 2002-12-03 2003-06-03  
5092 2001-09-25 2001-12-04  
5062 2001-08-31 2001-09-25  
5020 2001-01-26 2001-04-27  
4099 2000-10-03 2001-01-03  
4020 1998-03-25 1998-09-30  
3099 1997-10-08 1998-03-08  
2099 1997-03-17 1997-09-17  
1000 1995-12-13 1996-06-13  

Implementation Dates

date of Ratification (DOR) (1) 2003-09-01
date of Availability (DAV) (2) 2003-12-22
date of Announcement (DOA) (3) 2004-03-01
date of Publication (DOP) (4) 2004-09-01
date of Withdrawal (DOW) (5) 2005-09-01


Supersedes EN 50061:1988
EN 50061:1988/A1:1995
EN 50061:1988/A1:1995/corrigendum Oct. 1995
Superseded by  
Normative reference (6)  

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of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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