1 Scope and object
This part of IEC 61223 applies to CT scanners that conform
to IEC 60601‑2‑44:2009,
IEC 60601‑2‑44:2009/AMD1:2012 and IEC 60601‑2‑44:2009/AMD2:2016.
IEC 60601‑2‑44
and this document
-
• defines the essential parameters which describe the performance of CT
scanners with regard to image quality, radiation
output and patient positioning; the list of parameters to
be tested can be found in 4.3,
-
• defines the methods of testing the essential parameters, and
-
• evaluates compliance with the tolerances of the parameters specified
by the accompanying documents.
The methods defined in IEC 60601‑2‑44
and this document rely on non-invasive measurements, using appropriate test
equipment, performed during or after installation. Signed statements covering steps
in the installation procedure can be used as part of the acceptance
test report.
This document applies to acceptance tests and
constancy
tests on a CT scanner. The aim of the
acceptance
tests is to verify compliance of the installation or
major service
action with specifications affecting the image quality,
radiation output and patient positioning. The
constancy
tests are performed to ensure that the functional
performance of equipment meets established criteria and to enable
the early recognition of changes in the properties of components of the
equipment, and to verify compliance with specifications affecting the
image quality, radiation output and patient positioning.
This document also contains requirements associated with acceptance
test and constancy test for the
accompanying documents of the CT scanner.
This document does not apply to
-
• aspects of mechanical and electrical safety, and
-
• aspects of mechanical, electrical and software performance, unless they are
essential for performing the acceptance tests and
constancy tests, and are directly affecting
image quality, radiation output and patient
positioning.
NOTE 1 If a user of this document wishes to apply this document to CT scanners
that were designed to comply with editions of IEC 60601‑2‑44:2009
and earlier, understanding and adjustment for the different definitions that
have been used for CTDIvol is critical. Additionally, the
accompanying documents for CT scanners that were designed and
manufactured to these older editions can be referenced to obtain applicable
specifications.
NOTE 2 It is possible the accompanying documents that were compiled in accordance with
IEC 60601‑2‑44:2009
and IEC 60601‑2‑44:2009/AMD1:2012 or IEC 60601‑2‑44:2009,
IEC 60601‑2‑44:2009/AMD1:2012 and IEC 60601‑2‑44:2009/AMD2:2016 do not include
all the needed content and specifications identified in this document prior to
the completion of the transition period to this document.