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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 9-64: AAMI / ANSI / IEC 60601-2-2:2009, medical electrical equipment - part 2-2: particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. (ObGyn/Gastroenterology)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Endoscopic Electrosurgical Unit and Accessories (GI/GU), Electrohydraulic Lithotripor
Processes Affected:
510(k), PMA, IDE, PDP, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard

Transition:
FDA recognition of IEC 60601-2-2 2006 is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-2 2006 until December 31, 2013. After this transition period, declaration of conformity to IEC 60601-2-2 2006 will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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 Gastroscope And Accessories, Flexible/Rigid Class 2 FDS
§876.1500 Mini Endoscope, Gastroenterology-Urology Class 2 ODF
§876.1500 Pancreatoscope, Biliary Class 2 FTK
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§876.4300 Electrode, Electrosurgical, Active, Urological Class 2 FAS
§876.4300 Electrode, Flexible Suction Coagulator Class 2 FEH
§876.4300 Forceps, Biopsy, Electric Class 2 KGE
§876.4300 Unit, Electrosurgical Class 2 FAR
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
§876.4480 Lithotriptor, Electro-Hydraulic Class 2 FFK
Relevant Guidance:
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters. Issued November 30, 1998

Guidance for the Content of Premarket Notifications for Biopsy Devices used in Gastroenterology and Urology. Issued prior to February 27, 2997.
FDA Technical Contact:
 Isaac A. Chang
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1108
  Silver Spring MD 20993
  301/796-2789
  email: isaac.chang@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
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