• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

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

New Search Back To Search Results
Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 9-61: IEC 60601-2-18 Edition 3.0 2009-08, medical electrical equipment - part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment. (ObGyn/Gastroenterology)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Endoscopes and Accessories (GI/GU), Colposcope, Culdoscope, Hysteroscope, Falloposcope, Gynecologic Laparoscope, Breast Ductoscope
Processes Affected:
510(k), PMA, PDP, IDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard

Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§884.1690 Falloposcope Class 2 MKO
§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 And/Or Accessories Class 2 KOG
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Enteroscope And Accessories Class 2 FDA
§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 Hysteroscope (And Accessories) Class 2 HIH
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
Relevant Guidance:
Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k). Issued March 7, 1996.
FDA Technical Contact:
 Tuan Nguyen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G223
  Silver Spring MD 20993
  301/796-5174
  email: tuan.nguyen2@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-