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

Part B: Supplementary Information

Recognition Number 6-229: 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. (General Plastic Surgery/General Hospital)

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 COMPLIANCE (OC)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Electrosurgical Devices
Processes Affected:
510(k), PMA, IDE, pre-IDE, 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FDA recognition of IEC 60601-2-2:2006 is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance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 surgical accessories. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-2:2006 until June 30, 2013. After this transitional period, declarations 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
§878.4400 Apparatus, Electrosurgical Class 2 HAM
§878.4400 Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Class 2 NVJ
§878.4400 Electrode, Electrosurgical Class 2 JOS
§878.4400 Electrode, Gel, Electrosurgical Class 2 JOT
§878.4400 Electrosurgical Device Class 2 DWG
§878.4400 Electrosurgical, Cutting & Coagulation & Accessories Class 2 GEI
§878.4400 Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Class 2 NUJ
§878.4400 Generator,Electrosurgical,Coagulation,Cancer Class 2 MUL
§878.4400 System, Ablation, Microwave And Accessories Class 2 NEY
§878.4400 System, Ablation, Ultrasound And Accessories Class 2 NTB
§878.4400 Unit, Electrosurgical Andcoagulation, With Accessories Class 2 BWA
Relevant Guidance:
510(k) Guidance for General, Surgical Electrosurgical Devices (May 10, 1995 New Division Name - Division of General Restorative and Neurological Devices (DGRND))
FDA Technical Contact:
 Neil R. P. Ogden
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1438
  Silver Spring MD 20993
  301/796-6397
  email: neil.ogden@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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