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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 054 Date of Entry 07/06/2020 
FR Recognition Number 12-334
Standard
AAMI  RT3:2020
Radiation therapy machine characterization
Scope/Abstract
This standard defines a standard XML format for publishing and reporting the physical parameters of a C-Arm Radiation Therapy Linear Accelerator or the physical parameters in a software model of such a device.

Tomotherapeutic, multiple fixed source, robotic arm, light and heavy ion and other radiation treatment devices are not covered in this version.

This document does not claim full coverage of all configuration content. The scope is not intended to be comprehensive but to cover the majority of model conflict areas.

This document does not describe all the requirements and testing which might be necessary to validate that a combined system is safe and effective for use. For example, output factors are considered part of the dose calculation model.
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
§892.5050 Medical charged-particle radiation therapy system.
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Nancy Wersto
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6548
  nancy.wersto@fda.hhs.gov
 Amarjeet Bhullar
  FDA/OC/CDRH/OPEQ/OIDRH/DMQS/PMB/
  301-796-5917
  Amarjeet.Bhullar@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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