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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 6-389
Standard(Included in ASCA pilot)
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
This standard 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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 202.7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS
Subclause 202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
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.

This standard is recognized in part because:
Subclause 202.7 and subclause 202.8 are in conflict with an existing published final guidance, see section XII, Electrical Safety and Electromagnetic Compatibility of the guidance listed below (#3).
Subclause 202.7 and subclause 202.8 are in conflict with another recognized standard, see subclause 4.3.1 and subclause 8.1 of IEC 60601-1-2 Edition 4.1 2020-09 listed below (#6).
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§876.1500 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
§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
§876.4480 Lithotriptor, Electro-Hydraulic Class 2 FFK
§884.4120 Electrocautery, Gynecologic (And Accessories) Class 2 HGI
§884.4150 Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Class 2 HIN
§884.4160 Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Class 2 KNF
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery, Issued August 2016.

3. Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, Issued March 2020.

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

5. Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology, Issued February 1993.

6. IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

FDA Technical Contacts
 George Mattamal
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA/
  301-796-6396
  george.mattamal@fda.hhs.gov
 Long Chen
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA/
  301-796-6389
  long.chen@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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