IEC TR 63183-2019 PDF

Full title and description

St IEC TR 63183:2019 — Guidance on error and warning messages for software used in radiotherapy. This Technical Report provides best-practice guidance and concrete examples for the wording, presentation and handling of error, warning and informational messages in radiotherapy software; it supplements existing safety and usability requirements and is intended to improve clarity, reduce user error and support safe operation of radiation oncology systems.

Abstract

IEC TR 63183:2019 summarises recommended principles for the design and implementation of error and warning messages in radiotherapy software. The document presents design guidelines, message categories (critical error, warning, informational, system-status), examples tailored to radiation oncology workflows, and advice for integration with risk management and usability processes. It is intended as a practical supplement to safety/usability standards rather than as a mandatory safety requirement.

General information

• Status: Technical Report (IEC TR).
• Publication date: 11 December 2019 (IEC publication date).
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 11.040.60 (Therapy equipment / radiotherapy).
• Edition / version: Edition 1.0 (2019).
• Number of pages: 24 pages (IEC technical report PDF length).

Scope

This Technical Report gives guidance on the usage, form and content of error and warning messages written for software used in radiotherapy systems. It addresses message clarity, prioritisation by severity, recommended wording and presentation, examples specific to radiation oncology tasks, and considerations for localisation, logging and human factors. The report explicitly does not replace safety requirements in existing standards but is intended to be used alongside usability and risk-management standards to improve software-user communication in radiotherapy.

Key topics and requirements

• Classification of messages (critical error, warning, informational, system-status) and recommended actions for each class.
• Guidelines for concise, unambiguous wording that supports rapid comprehension and correct operator response.
• Presentation and layout recommendations for dialog boxes, alerts and logs (priority, visibility, persistence).
• Examples of message text tailored to radiation oncology workflows and device interactions.
• Integration of messages with risk management, logging, incident reporting and usability engineering processes.
• Localization, translation and cultural considerations for patient- and operator-facing messages.
• Recommendations for support information, corrective actions, and links to troubleshooting or documentation.

Typical use and users

Manufacturers and development teams for radiotherapy software use this report when designing user interfaces and alarm/message systems. Typical users include software engineers, human factors/usability specialists, risk managers, quality assurance engineers, technical writers and product managers working on treatment planning systems, delivery control software, imaging and verification tools in radiation oncology.

Related standards

Relevant standards and guidance documents commonly used together with IEC TR 63183 include: IEC 62366 (application of usability engineering to medical devices), IEC 62304 (medical device software — software life-cycle processes), the IEC 60601 series (safety and essential performance of medical electrical equipment) and ISO 14971 (application of risk management to medical devices). These standards provide complementary requirements for usability engineering, software development lifecycle, electrical safety and risk management that support implementation of the message-design guidance in IEC TR 63183.

Keywords

radiotherapy, error messages, warning messages, software usability, human factors, radiation oncology, medical device software, risk management, message design, IEC TR 63183

FAQ

Q: What is this standard?

A: IEC TR 63183:2019 is a Technical Report providing guidance on the design, wording and presentation of error and warning messages for software used in radiotherapy systems; it is a non‑binding supplement to existing safety and usability standards.

Q: What does it cover?

A: It covers principles and best practices for message classification, concise wording, dialog presentation, severity prioritisation, examples specific to radiation oncology workflows, logging and integration with usability and risk‑management activities.

Q: Who typically uses it?

A: Software engineers, usability/human factors specialists, risk managers, QA engineers, technical writers and product managers at companies that develop treatment planning, delivery and verification software for radiotherapy.

Q: Is it current or superseded?

A: IEC TR 63183 was published in December 2019 as Edition 1.0. As a Technical Report it documents guidance; users should check with IEC or national standards bodies for the current status or any later revisions before relying on it for compliance work.

Q: Is it part of a series?

A: It is a standalone IEC Technical Report produced by TC 62/SC 62C (equipment for radiotherapy, nuclear medicine and radiation dosimetry) and is intended to complement IEC and ISO standards addressing usability, software lifecycle and risk management rather than being a numbered part of a single series.

Q: What are the key keywords?

A: Radiotherapy, error messages, warnings, software usability, human factors, message wording, risk management, IEC TR 63183.