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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 9-124
Standard
ISO CIE 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
Scope/Abstract
This document specifies colour-matching functions for use in colorimetry. Two sets of colour-matching functions are specified.
a) Colour-matching functions for the CIE 1931 standard colorimetric observer.
This set of colour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense from about 1° to about 4°, for vision at photopic levels of adaptation.
b) Colour-matching functions for the CIE 1964 standard colorimetric observer.
This set of clour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense greater than about 4°, for vision at sufficiently high photopic levels and with spectral power distributions such that no participation of the rod receptors of the retina is to be expected.
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
§876.1500 Angioscope Class 2 LYK
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1690 Falloposcope Class 2 MKO
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
§864.1860 Automated Digital Image Manual Interpretation Microscope Class 2 OEO
§864.3700 Digital Pathology Display Class 2 PZZ
§864.3700 Digital Pathology Image Viewing And Management Software Class 2 QKQ
§864.3700 Whole Slide Imaging System Class 2 PSY
Relevant FDA Guidance and/or Supportive Publications*
* Submission Guidance for a 510(k): Hysteroscopes and Gynecologic Laparoscopes, Issued March 7, 1996.
* Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, Issued April 2016.
* Cheng, W.C., Saleheen, F., and Badano, A. (2019). Assessing color performance of whole-slide imaging scanners for digital pathology. Color Research & Application, 44(3), 322-334.
* Lemaillet P. & Cheng W.C. (2020). Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices. Biomedical Optics Express, 11(3), 1449-1461.
FDA Technical Contact
 Wei-Chung Cheng
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-5169
  Wei-Chung.Cheng@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
CIE International Commission on Illumination http://cie.co.at/
FDA Specialty Task Groups (STG)
ObGyn/Gastroenterology/Urology (primary)
Radiology
*These are provided as examples and others may be applicable.
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