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

CLC/TC 62

Electrical equipment in medical practice

 

Project

Reference EN 50077:1993
Title Low-profile connector for implantable cardiac pacemakers
Project Number 4257
Abstract/Scope This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction. WARNING The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector. This European standard supplements EN 50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN 50061 regarding leads.
Status
Published

Status

Current Stage code 6060
Current Stage code date 1993-06-04
Current Stage code deadline 1993-12-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher BC/CLC/02-89

Details

IEC Technical Body IEC/SC 62D
Reference Document  
ICS  
Keywords Medical; Pacemaker; Cardiac; Implantable; Low-profile connector
Note Corrigendum to EN issued November 1993
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1993-06-04 1993-12-01 export to doc file  EN
6020 1992-04-24 1992-07-24  
5099 1992-03-24 1992-04-24  
5091 1991-12-10 1992-06-10  
5020 1991-06-20 1991-10-30  
3090 1991-03-15 1991-09-15  
5099 1990-12-10 1991-01-10  
5020 1990-06-15 1990-09-30  
4099 1990-03-05 1990-08-05  
5020 1989-05-25 1989-11-30  

Implementation Dates

date of Ratification (DOR) (1) 1992-03-24
date of Availability (DAV) (2) 1993-06-04
date of Announcement (DOA) (3) 1992-04-01
date of Publication (DOP) (4) 1993-12-01
date of Withdrawal (DOW) (5) 1993-12-01

Relations

Supersedes  
Superseded by  
Normative reference (6) EN 50061:1988

(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.