Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-229: AAMI / ANSI / IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. (General Plastic Surgery/General Hospital)
Date of Standard: 2009. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
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| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| 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 Office and Division Associated with Recognized Standards: |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, IDE, pre-IDE, 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FDA recognition of IEC 60601-2-2:2006 is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical accessories. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-2:2006 until June 30, 2013. After this transitional period, declarations 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 |
| §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 Device |
Class 2 |
DWG |
| §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 |
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 |
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| Relevant Guidance: |
| 510(k) Guidance for General, Surgical Electrosurgical Devices (May 10, 1995 New Division Name - Division of General Restorative and Neurological Devices (DGRND)) |
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| FDA Technical Contact: |
| Neil R. P. Ogden |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1438 |
| Silver Spring MD 20993 |
| 301/796-6397 |
| Email: neil.ogden@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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