Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-202: IEC 60601-2-43 - Ed. 2.0 2010-03, Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. (Radiology)

Date of Standard: 2010.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

ALL OFFICES AND DIVISIONS IN CDRH

Devices Affected:

X-ray Equipment Interventional Procedures

Processes Affected:

510(k), IDE, HDE

Type of Standard:

Horizontal, International

Extent of Recognition:

Complete standard

Transition:
FDA recognition of IEC 60601-2-43 Ed. 1.0:2000 is hereby superseded by recognition of IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-43- Ed. 1.0:2000 until June 30, 2013. After this transitional period, declaration of conformity to Ed. 1.0:2000 of the standard will not be accepted.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.1650	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Class 2	MQB
§892.1650	System, X-Ray, Fluoroscopic, Image-Intensified	Class 2	JAA