Recognized Consensus Standards

Recognition List Number: 024 Publication Date: 06/10/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-228: 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. (General Plastic Surgery/General Hospital)

Date of Standard: 2009.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF COMPLIANCE (OC)

(3)	OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)

Devices Affected:

Electrosurgical Devices

Processes Affected:

510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls

Type of Standard:

International, Vertical

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FDA recognition of IEC 60601-2-2-2006, is hereby superseded by recognition of IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential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 60601-2-2-2006 until June 30, 2013. After the transitional period, declaration of conformity to IEC 60601-2-2:2006 will not be accepted.

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 Coagulation For Aesthetic	Class 2	ONQ
§878.4400	Electrosurgical Device	Class 2	DWG
§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	Generator,Electrosurgical,Coagulation,Cancer	Class 2	MUL
§878.4400	Low Energy Direct Current Thermal Ablation System	Class 2	OAB
§878.4400	Surgical Device, For Ablation Of Cardiac Tissue	Class 2	OCL
§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