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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 12-333
Standard
IEC TR 63183 Edition 1.0 2019-12
Guidance on error and warning messages for software used in radiotherapy
Scope/Abstract
This document, which is a Technical Report, provides guidance on the usage and form of error or warning messages written for software used in RADIOTHERAPY. It does not replace any
requirements existing in the safety standards but is meant to be used as a supplement to existing standards on usability by providing specific examples in the field of RADIOTHERAPY.
The two main goals of this document are
1) to present in a concise manner the best practices and design guidelines for good message dialogs, and
2) to illustrate these design guidelines with specific examples from the field of radiation oncology.

This document is intended to be read by the following MANUFACTURERS' employees and representatives:
- engineering department members including: software engineers, RISK managers, quality assurance engineers, technical writers, etc.;
- usability and human factors engineers;
- marketing representatives (product marketing, product managers, business analysts).

Throughout this document, unless specifically called out, these guidelines apply to all categories of messages summarily called error or warning messages
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 Cyclotron, Medical Class 2 IWK
§892.5050 Synchrotron, Medical Class 2 IWM
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Microtron, Medical Class 2 JAE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System, Planning, Radiation Therapy Treatment Class 2 MUJ
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5050 Dosimeter, Ionizing Radiation, Implanted Class 2 NZT
FDA Technical Contacts
 Amarjeet Bhullar
  FDA/OC/CDRH/OPEQ/OIDRH/DMQS/PMB/
  301-796-5917
  Amarjeet.Bhullar@fda.hhs.gov
 Nancy Wersto
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6548
  nancy.wersto@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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