Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 12-341
Standard
IEC  62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
Scope/Abstract
This 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.
Extent of Recognition
Complete standard
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.
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.
FDA Technical Contact
 Aldo Badano
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-2534
  Aldo.Badano@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
-
-