IEC 62274 First Edition 2005-05

Standard Organization:

IEC 62274 First Edition 2005-05
Medical electrical equipment - Safety of radiotherapy record and verify systems

• Recognition Date: 2012-03-16
• Recognition List: 028
• Recognition Number: 12-241
• 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 and manufacture and some installation aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical practice that

a) provides, defines, or displays treatment machine set up data; imports data either through input by the OPERATOR or directly from other devices,

b) may control the ability of that equipment to operate;

c) records data of all TREATMENT sessions; and d) is intended to be:

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

2) maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE; and

3) used within the environmental and electrical supply conditions specified in the technical description.

This standard does not address dynamic beam deliveries. NOTE This may be addressed in a future version of this standard.

It does, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§892.5900	System, Therapeutic, X-Ray	Class 2	JAD
§892.5750	System, Radiation Therapy, Radionuclide	Class 2	IWB
§892.5050	Accelerator, Linear, Medical	Class 2	IYE
§892.5050	System, Radiation Therapy, Charged-Particle, Medical	Class 2	LHN

FDA Guidance:

There is no relevant guidance developed at this time.