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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 6-389
Standard
IEC 60601-2-2 Edition 6.0 2017-03
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
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-2:2017
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
Scope/Abstract
IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.

HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.

The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories.

This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:

- refinement and additions to the defined terms;

- additional separation of the requirements for HF surgical equipment and HF surgical accessories;

- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;

- new requirements for devices that have or use a high current mode.

Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§884.4160 Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Class 2 KNF
§884.4150 Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Class 2 HIN
§884.4120 Electrocautery, Gynecologic (And Accessories) Class 2 HGI
§878.4400 Electrode, Electrosurgical Class 2 JOS
§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 Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue Class 2 OCL
§878.4400 System, Ablation, Microwave And Accessories Class 2 NEY
§876.4480 Lithotriptor, Electro-Hydraulic Class 2 FFK
§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 Snare, Flexible Class 2 FDI
§876.4300 Unit, Electrosurgical Class 2 FAR
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
§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 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
Relevant FDA Guidance and/or Supportive Publications
Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff, Issued August 2016.

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery- Guidance for Industry and Food and Drug Administration Staff, Issued August 2016

Guidance for Industry: Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.,Issued November 1998.

Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology, Issued February 1993.
FDA Technical Contacts
 George Mattamal
  FDA/OMPT/CDRH/ODE/DSD/GSDB2/
  301-796-6396
  george.mattamal@fda.hhs.gov
 Long Chen
  FDA/OMPT/CDRH/ODE/DSD/GSDB2/
  301-796-6389
  long.chen@fda.hhs.gov
 Isaac A. Chang
  FDA/OMPT/CDRH/OSB/DPS/
  301-796-2789
  isaac.chang@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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