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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 12-211
Standard(Included in ASCA)
IEC  60601-2-29 Edition 3.0 2008-06
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
This Particular Standard applies to RADIOTHERAPY SIMULATORS:

- that use diagnostic X-RAY EQUIPMENT to simulate physically a RADIOTHERAPY RADIATION BEAM, so that the TREATMENT VOLUME to be subjected to IRRADIATION during RADIOTHERAPY can be localized, and the position and of the RADIOTHERAPY RADIATION FIELD can be confirmed;

- intended exciusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations;

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

- comprising the following parts:

a system for producing an X-RAY BEAM, which simulates the geometry of the RADIOTHERAPY RADIATION BEAM;

a system for producing images of the transmitted X-RAY BEAM, for example, either by RADIOGRAPHY or RADIOSCOPY;

an assembly to control the and position of the RADIATION BEAM and to delineate the intended treatment area;

a mechanical structure that physically simulates the geometry and movements of the RADIOTHERAPY EQUIPMENT and supports the imaging system;

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.5840 System, Simulation, Radiation Therapy Class 2 KPQ
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 John Chen
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.