IEC 60601-2-11 Edition 3.0 2013-01

Standard Organization:

IEC 60601-2-11 Edition 3.0 2013-01
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Recognition Date	2013-08-06
Recognition List	031
Recognition Number	12-255
Extent	Complete standard
Standards Orgs	IEC International Electrotechnical Commission http://www.iec.ch/
STG	Radiology
FDA Tech	John Chen FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6540 john.chen@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

Code of Federal Regulations:

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
§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, Planning, Radiation Therapy Treatment	Class 2	MUJ
§892.5050	System, Radiation Therapy, Charged-Particle, Medical	Class 2	LHN

FDA Guidance:

There is no relevant guidance developed at this time.