Recognized Consensus Standards

Recognition List Number: 018 Publication Date: 09/12/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-133: IEC 60601-2-11 (1997)(2004), Amendment 1 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment. (Radiology)

Date of Standard: 1997.

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:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Radionuclide Radiation Therapy Systems

Processes Affected:

510(k)s, PMAs, IDEs, HDEs, PDPs

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard and any annexes with specific national alterations

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.5050	Accelerator, Linear, Medical	Class 2	IYE
§892.5050	Accessory - Film Dosimetry System	Class 2	MWW
§892.5050	Betatron, Medical	Class 2	IYG
§892.5050	Cyclotron, Medical	Class 2	IWK
§892.5050	Microtron, Medical	Class 2	JAE
§892.5050	Synchrotron, Medical	Class 2	IWM
§892.5050	System, Radiation Therapy, Charged-Particle, Medical	Class 2	LHN
§892.5050	System,Planning,Radiation Therapy Treatment	Class 2	MUJ

Regulation Number	Device Name	Device Class	Product Code
§892.5750	Device, Beam Limiting, Teletherapy, Radionuclide	Class 2	IWD
§892.5750	System, Radiation Therapy, Radionuclide	Class 2	IWB