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

 

Project

Reference EN 60601-2-54:2009
Title Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Project Number 21882
Abstract/Scope IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54.
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 2009-09-18
Current Stage code deadline 2010-05-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-54:2009 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical,X-ray;Radiography;Radioscopy;Safety
Note Supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and (partially) EN 60601-2-28:1993 * Partially superseded by EN 60601-2-43:2010
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2009-09-18 2010-05-01 export to doc file  EN  FR  DE
5099 2009-08-01 2009-10-01  
5060 2009-06-02 2009-06-16 export to doc file  EN
5020 2009-03-27 2009-05-29  
3090 2009-02-13 2009-03-01  
5060 2008-10-28 2008-11-11 export to doc file  EN
5020 2008-05-23 2008-10-24  
1090 2008-05-20 2008-05-23  

Implementation Dates

date of Ratification (DOR) (1) 2009-08-01
date of Availability (DAV) (2) 2009-09-18
date of Announcement (DOA) (3) 2009-11-01
date of Publication (DOP) (4) 2010-05-01
date of Withdrawal (DOW) (5) 2012-08-01

Relations

Supersedes EN 60601-2-7:1998
EN 60601-2-28:1993
EN 60601-2-32:1994
Superseded by EN 60601-2-43:2010
Normative reference (6) EN 60336:2005
EN 60580:2000
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-3:2008
corr. March 2010
IEC/TR 60788:2004
EN 60806:2004
EN 62220-1:2004

(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.