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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 12-344
IEC  62563-2 Edition 1.0 2021-11
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
This part of IEC 62563 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document 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. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.2050 System, Image Processing, Radiological Class 2 LLZ
§892.2050 Display, Diagnostic Radiology Class 2 PGY
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration 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
 Wei-Chung Cheng
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.