Publication details
| Publication CODE |
Title |
| NBN EN IEC 61223-3-6:2020 (2020-04) |
EVALUATION AND ROUTINE TESTING in MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT USED in A MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION |
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| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3. |
Description
IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose.
Excluded from the scope of this document are:
- MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS;
- 2D images synthesised from the tomosynthesis images;
- reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS;
- CT SCANNERS covered by IEC 61223-3-5.
IEC 61223-3-6:2020 defines
a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose,
b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and
c) CONSTANCY TEST frequency when required.
This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation.
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.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.
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| Class |
C
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Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered electronically on our website, but isn't available
via this link. Please contact the BEC if you want to buy this text and we'll
give you the appropriate link.
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DE version
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EN version
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FR version
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Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
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Origin
| Committee |
CLC/TC 62
Electrical equipment in medical practice
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Approval
| BEC Approval |
2020-03-13 |
| NBN Approval |
2020-04-29 |
| ICS-Code (International Standards Classification) |
11.040.50
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2020-03-13 |
| Date of availability (d.a.v.) |
2020-04-03 |
| Date of announcement (d.o.a.) |
2020-06-13 |
| Date of publication (d.o.p.) |
2020-12-13 |
| Date of withdrawal former edition (d.o.w.) |
2023-03-13 |
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Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN IEC 61223-3-6:2020
|
2020-04-03 |
| is identical to |
IEC 61223-3-6:201X
|
|
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-2-45:2011 |
|
| Standard |
Belgium |
NBN EN 60601-2-45:2011/A1:2015 |
|
| Standard |
Belgium |
NBN EN 61223-3-2:2009 |
|
| Standard |
Belgium |
NBN EN 61674:2013 |
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