IEC 61217 Edition 2.0 2011-12

Standard Organization:

IEC 61217 Edition 2.0 2011-12
Radiotherapy equipment - Coordinates, movements, and scales

Recognition Date	2014-01-30
Recognition List	034
Recognition Number	12-267
Extent	Complete standard
Standards Orgs	IEC International Electrotechnical Commission http://www.iec.ch/
STG	Radiology
FDA Tech	Nancy Wersto FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6548 nancy.wersto@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 equipment and data related to the process of TELERADIOTHERAPY, including PATIENT image data used in relation with RADIOTHERAPY TREATMENT PLANNING SYSTEMS, RADIOTHERAPY SIMULATORS, isocentric GAMMA BEAM THERAPY EQUIPMENT, isocentric medical ELECTRON ACCELERATORS, and non-isocentric equipment when relevant.

The object of this standard is to define a consistent set of coordinate systems for use throughout the process of TELERADIOTHERAPY, to define the marking of scales (where provided), to define the movements of ME EQUIPMENT used in this process, and to facilitate computer control when used.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§892.5840	System, Simulation, Radiation Therapy	Class 2	KPQ
§892.5750	Device, Beam Limiting, Teletherapy, Radionuclide	Class 2	IWD
§892.5750	System, Radiation Therapy, Radionuclide	Class 2	IWB
§892.5300	System, Radiation Therapy, Neutron, Medical	Class 2	IWL
§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	Dosimeter, Ionizing Radiation, Implanted	Class 2	NZT
§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.