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

 

Project

Reference EN 45502-2-2:2008
Title Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Project Number 8622
Abstract/Scope This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this particular standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502–2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2008-03-31
Current Stage code deadline 2008-10-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62D
Reference Document  
ICS 11.040.40 - Implants for surgery, prosthetics and orthotics
Keywords Medical device; Implantable; Safety; Tachyarrhythmia; Defibrillator
Note EN 45502-2-1:2003 & EN 45502-2-2 supersede EN 50061:1988 + A1:1995 * Published as a CENELEC standard (one logo)
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2008-03-31 2008-10-01 export to doc file  EN  FR  DE
5099 2007-05-01 2007-09-01  
5061 2007-03-27 2007-05-01  
5060 2006-11-14 2006-11-28 export to doc file  EN
5020 2006-09-08 2006-11-10 export to doc file  EN
4099 2006-05-12 2006-08-19  
4020 1998-03-25 1998-09-30  
3099 1997-10-08 1998-03-08  
2020 1997-03-17 1997-09-17  

Implementation Dates

date of Ratification (DOR) (1) 2007-05-01
date of Availability (DAV) (2) 2008-03-31
date of Announcement (DOA) (3) 2007-11-01
date of Publication (DOP) (4) 2008-10-01
date of Withdrawal (DOW) (5) 2010-05-01

Relations

Supersedes EN 50061:1988
EN 50061:1988/A1:1995
EN 50061:1988/A1:1995/corrigendum Oct. 1995
Superseded by  
Normative reference (6) ANSI/AAMI PC69:2007
EN 980:2008
EN 45502-1:1997
EN 45502-2-1:2003
EN 60068-2-27:1993
EN 60068-2-47:2005
EN 60068-2-64:1994
IEC 60878:1988

(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.