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

 

Project

Reference EN 62220-1-2:2007
Title Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
Project Number 16995
Abstract/Scope Specifies the method for the determination of the detective quantum efficiency (DQE) of digital X-ray imaging devices as a function of air kerma and of spatial frequency for the working conditions in the range of the medical application as specified by the manufacturer. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories. This Part 1-2 is restricted to digital X-ray imaging devices that are used for mammographic imaging such as but not exclusively, CR systems, direct and indirect flat panel detector based systems, scanning systems (CCD based or photon-counting). This part of IEC 62220 is not applicable to - digital X-ray imaging devices intended to be used in general radiography or in dental radiography; - computed tomography; and - devices for dynamic imaging (where series of images are acquired, as in fluoroscopic or cardiac imaging).
Status
Published

Status

Current Stage code 6060
Current Stage code date 2007-09-20
Current Stage code deadline 2008-06-01
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 62220-1-2:2007 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical equipment; Imaging device; X-ray; Digital; Mammography
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2007-09-20 2008-06-01 export to doc file  EN  FR  DE
5099 2007-09-01 2008-01-01  
5061 2007-06-26 2007-09-01  
5060 2007-05-29 2007-06-11 export to doc file  EN
5020 2007-03-23 2007-05-25  
4099 2006-10-20 2006-12-15  
4020 2005-08-05 2006-01-06  
3099 2005-08-02 2005-08-05  

Implementation Dates

date of Ratification (DOR) (1) 2007-09-01
date of Availability (DAV) (2) 2007-09-20
date of Announcement (DOA) (3) 2007-12-01
date of Publication (DOP) (4) 2008-06-01
date of Withdrawal (DOW) (5) 2010-09-01

Relations

Supersedes  
Superseded by  
Normative reference (6) ISO 12232:1998
EN 60336:2005
EN 60601-2-45:2001
IEC/TR 60788:2004
EN 61267:2006
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.