EN IEC 62083:2026/prA1:2026

• Status: Not Published
• Publication Date: 05-Dec-2027
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 07-Aug-2026
• Completion Date: 07-Aug-2026
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 62083:2026/oprA1:2026 - Amendment 1 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems

• Amends: EN IEC 62083:2026 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
• Effective Date: 10-Feb-2026

Overview

EN IEC 62083:2026/prA1:2026 is Amendment 1 to the international standard for medical device software, specifically addressing the safety requirements for radiotherapy treatment planning systems. Published by CLC in collaboration with the International Electrotechnical Commission (IEC), this amendment is a critical update to the third edition of IEC 62083, released in 2025. It focuses on operational safety enhancements, specifically the compliance checks during the installation of radiotherapy treatment planning software, ensuring accuracy and safety in clinical settings.

Key Topics

• Medical device software safety: Details specific requirements for software used in radiotherapy treatment planning, ensuring accurate and secure operation.
• Radiotherapy treatment planning systems: Defines expectations for system performance and compliance regarding patient safety and data integrity.
• Type testing (TYPE TEST): Introduces updated type test procedures, with emphasis on hardware specifications and system installation validation.
• Compliance checks: Outlines the new compliance check for the installation process to better ensure conformity and safety.
• Operational safety: Stresses general and security-related requirements to manage clinical risks and promote best practices.
• International harmonization: Developed by IEC SC 62C (Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry) and adopted into the European regulatory framework.

Applications

This amendment is essential for a range of stakeholders involved in the development, deployment, and regulation of medical device software in radiotherapy:

• Manufacturers and developers: Gain clear guidelines on required compliance statements for hardware used during type testing, improving product safety and reliability.
• Healthcare providers and hospitals: Assure that installed radiotherapy planning software has undergone proper compliance checks, supporting treatment effectiveness and patient safety.
• Verification and testing labs: Follow consistent processes for validation and compliance verification, particularly regarding system hardware configurations and type tests.
• Regulatory and certification bodies: Use the clarified compliance requirements to ensure that medical device software meets international safety standards.
• Clinical physicists and IT professionals: Implement and maintain radiotherapy planning solutions aligned with up-to-date safety requirements, minimizing risk during installation and operation.

By adhering to this amendment, organizations help maintain operational safety in radiotherapy environments and support regulatory conformity assessment processes.

Related Standards

Professionals working with EN IEC 62083:2026/prA1:2026 should also be familiar with the following international standards relevant to medical device software and radiotherapy:

• IEC 62083:2025 - Medical device software – Requirements for the safety of radiotherapy treatment planning systems (main standard).
• IEC 60601 Series - Safety and performance of medical electrical equipment.
• ISO 13485 - Quality management systems for medical devices.
• IEC 62304 - Medical device software life cycle processes.
• ISO/IEC 27001 - Information security management, relevant for data protection in medical settings.

Understanding and implementing this amendment alongside related standards ensures compliance, supports patient safety, and strengthens the reliability of medical device software in radiotherapy settings.

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Keywords: EN IEC 62083, radiotherapy safety, medical device software, treatment planning systems, type testing, compliance check, healthcare technology standards, CLC, IEC 62083:2026, operational safety, certification, regulatory compliance, clinical risk management, radiotherapy system installation.

SLOVENSKI STANDARD
01-julij-2026
Programska oprema za medicinske aparate - Zahteve za varnost sistemov za
načrtovanje radioterapevtske obravnave - Dopolnilo A1
Amendment 1 - Medical device software - Requirements for the safety of radiotherapy
treatment planning systems
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von
Bestrahlungsplanungssystemen
Logiciels de dispositifs médicaux - Exigences de sécurité pour les systèmes de
planification de traitement en radiothérapie
Ta slovenski standard je istoveten z: EN IEC 62083:2026/prA1:2026
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62C/981/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 62083/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-05-15 2026-08-07
SUPERSEDES DOCUMENTS:
62C/973/RR
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62B
ASPECTS CONCERNED:
Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which t hey
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Amendment 1 - Medical device software - Requirements for the safety of radiotherapy treatment
planning systems
PROPOSED STABILITY DATE: 2036
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

IEC CDV 62083/AMD1 © IEC 2026
1 CONTENTS
2 FOREWORD . 2
3 INTRODUCTION TO THE AMENDMENT . 4
4 6 General requirements for operational safety . 5
5 6.5 Security . 5
6 6.5.5 Installation of RADIOTHERAPY TREATMENT PLANNING SYSTEM (3.61) . 5
IEC CDV 62083/AMD1 © IEC 2026
9 INTERNATIONAL ELECTROTECHNICAL COMMISSION
10 ____________
12 Medical device software –
14 Requirements for the safety of radiotherapy treatment planning systems
16 AMENDMENT 1
18 FOREWORD
19 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
20 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
21 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
22 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
23 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
24 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
25 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
26 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
27 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
28 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an int
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