IEC 62083 Edition 2.0 2009-09

Standard Organization:

IEC 62083 Edition 2.0 2009-09
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

• Recognition Date: 2011-03-14
• Recognition List: 026
• Recognition Number: 12-217
• 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 the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS)

- for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;

- that imports data either through input by the OPERATOR or directly from other devices;

- that outputs data either in printed form for review or directly to other devices;

- and which is intended to be

- for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training;

- maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and

- used within the environmental and electrical supply conditions SPECIFIED in the technical description.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§892.5900	Collimator, Dermatological, Therapeutic X-Ray	Class 2	IYL
§892.5900	Collimator, High Voltage, Therapeutic X-Ray	Class 2	IYK
§892.5900	Collimator, Low Voltage, Therapeutic X-Ray	Class 2	IYJ
§892.5900	Collimator, Orthovoltage, Therapeutic X-Ray	Class 2	IYI
§892.5900	Device, Beam Limiting, X-Ray, Therapeutic	Class 2	KQA
§892.5900	Generator, Dermatological (Grenz Ray), Therapeutic X-Ray	Class 2	IYH
§892.5900	Generator, High Voltage, X-Ray, Therapeutic	Class 2	KPZ
§892.5900	Generator, Low Voltage, Therapeutic X-Ray	Class 2	IYD
§892.5900	Generator, Orthovoltage, Therapeutic X-Ray	Class 2	IYC
§892.5900	System, Therapeutic, X-Ray	Class 2	JAD
§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	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.