Zdravotnické elektrické přístroje

Komise : IEC/SC 62B (Diagnostic imaging equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 11.08.2020
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Amendment

Komise : IEC/SC 62B (Diagnostic imaging equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 25.08.2020
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This part of IEC 61223-3 applies to dental cone-beam computed tomography x-ray equipment, hereafter also called dental cbct equipment that conforms to IEC 60601-2-63 Ed. 1.1

NOTE 1:           dental cbct equipment is a subset of dental extra-oral X-ray equipment.

NOTE 2:           Dental extra-oral x- ray equipment may provide one or more of panoramic, cephalometric, tomosynthesis and dental CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 safety standard.

This standard applies to acceptance tests and constancy tests on dental cone-beam computed tomography x-ray equipment.

The aim of 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 requirements specified in this standard are minimal requirements. The manufacturer may establish criteria for the tests described here that exceed the levels contained in this standard.

Constancy tests are performed to ensure that the functional performance of me equipment meets established criteria and to enable the early recognition of changes in the properties of components of the me equipment, and to verify compliance with specifications affecting the image quality, radiation output and patient positioning.

This standard also contains requirements for the accompanying documents associated with acceptance and constancy testing of the dental cbct equipment.

This standard does not apply to:

aspects of thermal, EMC, mechanical and electrical safety;

aspects of mechanical, electrical and software performance, unless they are essential for performing the acceptance tests and constancy tests, and directly affect image quality, radiation output and patient positioning.

NOTE 3:           Such aspects are generally addressed by the IEC 60601-1 series.

Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this standard.

Dental extra-oral x-ray equipment may provide modalities which are in the scope of the IEC 61223-3-4 standard. In this case, both parts of the IEC 61223 series apply.

Komise : IEC/SC 62B (Diagnostic imaging equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.09.2020
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This part of IEC 62563 establishes the performance criteria and test frequencies for the Acceptance test and Constancy test. The evaluation methods are defined in IEC 62563-1. The scope of this International Standard is directed to practical tests that can be visually evaluated or measured using basic test equipment. This standard applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems.

Komise : IEC/SC 62B (Diagnostic imaging equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.09.2020
Zobraz více Zobraz méně
 

Amendment