Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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12-341
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Standard | |
IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
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Scope/AbstractThis part of IEC 62563 describes the evaluation methods for testing medical IMAGE DISPLAY SYSTEMS.
The scope of this International Standard is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document.
This standard applies to medical IMAGE DISPLAY SYSTEMS, which can display image information on greyscale and colour IMAGE DISPLAY SYSTEMS. This standard applies to medical IMAGE DISPLAY SYSTEMS used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted IMAGE DISPLAY SYSTEMS and IMAGE DISPLAY SYSTEMS used for confirming positioning and for operation of the system are not covered by this standard. Handheld IMAGE DISPLAY SYSTEMS might require additional or modified versions of the procedures described in this standard.
It is not in the scope of this standard to define the requirements of acceptance and constancy tests or the frequencies of constancy tests. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology, Issued October 2017.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |