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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 12-333
IEC  TR 63183 Edition 1.0 2019-12
Guidance on error and warning messages for software used in radiotherapy
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 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
 Amarjeet Bhullar
 Nancy Wersto
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.