Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-62: 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. (ObGyn/Gastroenterology)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
| Endoscopic Electrosurgical Unit and Accessories (GI/GU), Electrohydraulic Lithotriptor |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, GMP, Design Controls |
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| 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FDA recognition of IEC 60601-2-2 2006 is hereby superseded by recognition of IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential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. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60604-2-2006 until June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-2 2006 will not be accepted. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
Pancreatoscope, Biliary |
Class 2 |
FTK |
| §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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
Unit, Electrosurgical |
Class 2 |
FAR |
| §876.4300 |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
Class 2 |
KNS |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.4480 |
Lithotriptor, Electro-Hydraulic |
Class 2 |
FFK |
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| Relevant Guidance: |
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters. Issued November 30, 1998
Guidance for the Content of Premarket Notifications for Biopsy Devices used in Gastroenterology and Urology. Issued prior to February 27, 1997 |
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| FDA Technical Contact: |
| Isaac A. Chang |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1108 |
| Silver Spring MD 20993 |
| 301/796-2789 |
| Email: isaac.chang@fda.hhs.gov |
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| * 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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