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

 

Project

Reference EN 60601-2-44:2009
Title Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Project Number 21573
Abstract/Scope IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2009-05-20
Current Stage code deadline 2010-02-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-44:2009 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Safety; Performance; X-ray; Tomography
Note Covers pr=21186 (// proc on 62B/652/CDV cancelled)
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2009-05-20 2010-02-01 export to doc file  EN  FR  DE
5099 2009-05-01 2009-07-01  
5061 2009-03-27 2009-05-01  
5060 2009-02-16 2009-03-02 export to doc file  EN
5020 2008-12-12 2009-02-13  
3090 2008-09-19 2008-11-30  
5060 2008-04-23 2008-07-05 export to doc file  EN
5020 2007-11-16 2008-04-18  
1090 2007-11-13 2007-11-16  

Implementation Dates

date of Ratification (DOR) (1) 2009-05-01
date of Availability (DAV) (2) 2009-05-20
date of Announcement (DOA) (3) 2009-08-01
date of Publication (DOP) (4) 2010-02-01
date of Withdrawal (DOW) (5) 2012-05-01

Relations

Supersedes EN 60601-2-44:2001
EN 60601-2-44:2001/A1:2003
Superseded by  
Normative reference (6) ISO 12052:2006
EN 60601-1:2006
corr. March 2010
corr.
A11:2011
EN 60601-1-3:2008
corr. March 2010
EN 61223-3-5:2004

(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.