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 |
Recognition Date | 2017-08-21 |
Recognition List | 047 |
Recognition Number | 6-389 |
Extent | Complete standard |
Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
STG | General Plastic Surgery/General Hospital |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
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 |
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. |