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

 

Project

Reference EN 50061:1988
Title Safety of implantable cardiac pacemakers
Project Number 4253
Abstract/Scope This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac Pacemakers. This standard also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging. In addition, minimum requirements are specified for the ability of pacemakers to withstand environmental stress conditions. Appropriate test methods are given. This standard specifies the requirements for the reliable operation of pacemakers only insofar as they affect safety. It does not cover the antitachyarrythmia and defibrillation functions of pacemakers, nor pacemakers operated by isotopic cells
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 1988-05-01
Current Stage code deadline 1989-01-01
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; Safety
Note To be implemented in all countries except AT & NO * Will be superseded by EN 45502-2-1 (pr=7407) & EN 45502-2-2 (pr=8622)
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6020 1988-11-18 1988-06-02  
6060 1988-05-01 1989-01-01 export to doc file  EN
5099 1988-03-02 1988-04-02  
5020 1987-09-18 1988-01-01  
4099 1987-05-25 1987-10-31  
4020 1986-04-23 1986-10-31  
3020 1985-09-01 1985-10-12  
2020 1985-07-10 1985-09-29  

Implementation Dates

date of Ratification (DOR) (1) 1988-03-01
date of Availability (DAV) (2) 1988-05-01
date of Announcement (DOA) (3) 1988-09-01
date of Publication (DOP) (4) 1989-01-01
date of Withdrawal (DOW) (5) 1989-01-01

Relations

Supersedes  
Superseded by EN 45502-2-1:2003
EN 45502-2-2:2008
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.