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

 

Project

Reference EN 62353:2008
Title Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Project Number 17026
Abstract/Scope Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed. This standard contains: - 'general requirements', which contain clauses of general concern, and - 'particular requirements', further clauses handling special types of me equipment or me systems and applying in connection with the 'General requirements'. This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2008-01-25
Current Stage code deadline 2008-08-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 62353:2007 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical; Test; Recurrent; After repair test
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2008-01-25 2008-08-01 export to doc file  EN  FR  DE
5099 2007-09-11 2007-11-11  
5062 2007-07-01 2007-09-11  
5061 2007-05-23 2007-07-01  
5060 2007-03-20 2007-04-02 export to doc file  EN
5020 2007-01-12 2007-03-16  
4099 2006-07-14 2006-11-10  
4020 2005-09-09 2006-02-10  
3099 2005-09-06 2005-09-09  

Implementation Dates

date of Ratification (DOR) (1) 2007-09-11
date of Availability (DAV) (2) 2008-01-25
date of Announcement (DOA) (3) 2008-01-01
date of Publication (DOP) (4) 2008-08-01
date of Withdrawal (DOW) (5) 2010-10-01

Relations

Supersedes  
Superseded by FprEN 62353:2013
Normative reference (6) HD 60364-7-710:2012
corr.
EN 61010-1:2001
corr. June 2002
EN 61010-2-010:2003
EN 61010-031:2002
EN 61140:2002
EN 61557-1:2007
IEC 60417-DB

(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.