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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 9-123
Standard
ISO 8600-3 Second edition 2019-08 Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
Scope/Abstract
This part of ISO 8600 specifies requirements and recommends test methods for measuring the field of view and direction of view of endoscopes.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 5.1 Method A (distal window reference)
Section 6.1 Method A

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.

Method A in sections 5.1 and 6.1 are in conflict with published literature when the endoscope working distance is not significantly longer than the distance between the distal end and entrance pupil, for instance, some endoscopes with a close focus distance or capsule endoscopes. See the citation listed below.
Transition Period
FDA recognition of 8600-3 First edition 1997-07-01 (Amendment 1 2003-12-01 [Rec# 9-84] will be superseded by recognition of ISO 8600-3 Second edition 2019-08 [Rec# 9-123]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-84] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 9-84] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§884.1690 Falloposcope Class 2 MKO
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
Regulation Number Device Name Device Class Product Code
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
Regulation Number Device Name Device Class Product Code
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
Regulation Number Device Name Device Class Product Code
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
Regulation Number Device Name Device Class Product Code
§884.1640 Culdoscope (And Accessories) Class 2 HEW
Relevant FDA Guidance and/or Supportive Publications*
Wang Q., Khanicheh A., Leiner D., Shafer D., and Zobel J., (2017). Endoscope field of view measurement. Biomedical Optics Express, 8 (3), pp. 1441-1454).
FDA Technical Contact
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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