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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 6-228: IEC 60601-2-2 Edition 5.0 2009-02, medical electrical equipment - part 2-2: particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. (General Plastic Surgery/General Hospital)

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
CDRH Offices and Divisions associated with recognized standards:
Devices Affected:
Electrosurgical Devices
Processes Affected:
510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete Standard

Related CFR Citations and Product Codes:
Device Name Device
§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 Coagulation For Aesthetic Class 2 ONQ
§878.4400 Electrosurgical Device Class 2 DWG
§878.4400 Electrosurgical Patient Return Electrode Class 2 ODR
§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 Low Energy Direct Current Thermal Ablation System Class 2 OAB
§878.4400 Surgical Device, For Ablation Of Cardiac Tissue Class 2 OCL
§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 Document for General, Surgical Electrosurgical Devices, Issued May 10, 1995
FDA Technical Contact:
 Neil R. P. Ogden
  10903 New Hampshire Avenue Building 66, Room 1438
  Silver Spring MD 20993
  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