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

 

Project

Reference EN 61223-3-2:2008
Title Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
Project Number 16931
Abstract/Scope This part of IEC 61223 applies to the effectiveness of mammographic X-ray equipment, with respect to image quality and dose, in combination with aspects of equipment safety. This standard applies to mammographic X-ray equipment and mammographic stereotactic devices. The tests described in this standard require the quality and performance of the X-ray image receptors to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-ray equipment. This includes radiographic films, intensifying screens, radiographic cassettes, storage phosphor plates and associated equipment such as film processors or storage phosphor plate readers, image display devices and hard copy cameras. For testing radiographic cassettes and intensifying screens, this standard makes reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are considered to be stated according to ISO 9236-3. By the measurements described in this standard, data for average glandular dose calculation can be determined. When the results of the acceptance test are in compliance with the expected values, the baseline values for the subsequent constancy tests are established. This part of IEC 61223 defines a) the essential parameters which describe the performance of the above-mentioned mammographic X ray equipment with regard to image quality and dose; and b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances. These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the acceptance test. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2008-07-25
Current Stage code deadline 2009-03-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 61223-3-2:2007 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Imaging; Acceptance test; Mammography; X-ray
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2008-07-25 2009-03-01 export to doc file  EN  FR  DE
5099 2008-06-01 2008-08-01  
5061 2008-04-28 2008-06-01  
5060 2007-06-11 2007-06-25 export to doc file  EN
5020 2007-04-06 2007-06-08  
4099 2007-04-03 2007-04-06  
4091 2006-02-03 2006-05-31  
4020 2005-07-15 2005-12-16  
3099 2005-07-12 2005-07-15  

Implementation Dates

date of Ratification (DOR) (1) 2008-06-01
date of Availability (DAV) (2) 2008-07-25
date of Announcement (DOA) (3) 2008-09-01
date of Publication (DOP) (4) 2009-03-01
date of Withdrawal (DOW) (5) 2011-06-01

Relations

Supersedes EN 61223-3-2:1996
Superseded by  
Normative reference (6) ISO 4090:2001
ISO 9236-3:1999
EN 60336:2005
EN 60601-1:2006
corr. March 2010
corr.
A11:2011
EN 60601-2-45:2001
IEC 61223-2-1:1993
EN 61674:1997
EN 61676:2002

(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.