SIST EN IEC 62083:2026/oprA1:2026

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

Programska oprema za medicinske aparate - Zahteve za varnost sistemov za načrtovanje radioterapevtske obravnave - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Jul-2026
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 19-May-2026
• Due Date: 06-Oct-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: EN IEC 62083:2026/prA1:2026 - Amendment 1 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems

Relations

• Amends: SIST EN IEC 62083:2026 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2025)
• Effective Date: 01-Jul-2026

Overview

SIST EN IEC 62083:2026/oprA1:2026 is an Amendment to the international standard for medical device software, focusing specifically on the safety requirements for radiotherapy treatment planning systems. Developed by the Slovenski inštitut za standardizacijo (SIST) and aligned with the International Electrotechnical Commission (IEC), this amendment updates critical safety compliance measures in radiotherapy planning software, ensuring higher reliability and patient protection in medical environments. Radiotherapy planning systems are essential for accurately delivering therapeutic doses to cancer patients, making safety requirements a top priority.

Key Topics

• Operational Safety: The amendment enhances general requirements for the operational safety of radiotherapy treatment planning systems.
• Security: Emphasis on improved security protocols during the installation and maintenance of the planning systems, preventing unauthorized access and data breaches.
• Compliance Checks: Introduction of new compliance verification steps, particularly focusing on type testing and hardware specification statements.
• Type Testing (TYPE TEST grade A): The amendment clarifies procedures and documentation for hardware used during type tests, supporting transparent validation of system safety.
• International Collaboration: The standard results from collaboration between IEC subcommittees, ensuring that globally recognized safety measures are incorporated.

Applications

Medical device software compliance under this standard is crucial for several stakeholders in the healthcare sector:

• Manufacturers of radiotherapy treatment planning systems must align their product development and quality assurance processes with updated safety requirements, performing detailed compliance checks.
• Regulatory authorities depend on these requirements to evaluate and approve radiotherapy planning systems before clinical deployment.
• Hospitals and clinics benefit by selecting software that meets the latest safety and security protocols, reducing clinical risks and safeguarding patient data.
• Software developers involved in medical device software design can utilize the clarified compliance requirements to streamline development, testing, and documentation workflows.
• Conformity assessment bodies gain a clear reference for auditing and certifying radiotherapy treatment planning solutions.

Related Standards

Several related standards further reinforce the safe and effective design and operation of medical device software in radiotherapy:

• IEC 62083:2025 - The base standard for safety in radiotherapy treatment planning systems, providing foundational requirements.
• ISO/IEC 62304 - Governs the lifecycle processes for medical device software, harmonizing procedures for development, maintenance, and risk management.
• EN IEC 60601 Series - Covers general and particular requirements for the safety and essential performance of medical electrical equipment, including radiotherapy machines.
• Relevant CENELEC standards - Address the harmonization of safety requirements for medical devices and software across the European market.

Practical Value

By adopting the enhancements introduced in SIST EN IEC 62083:2026/oprA1:2026, medical device manufacturers, health institutions, and regulatory bodies ensure:

• Improved patient safety through rigorous compliance and operational checks.
• Reduced clinical risk by upholding strict security and hardware validation.
• Alignment with the latest international best practices and regulatory expectations.
• Confidence in interoperability and safety for radiotherapy treatment systems worldwide.

Staying current with this amendment is essential for maintaining certification, market access, and a robust quality management system in the evolving field of medical device software for radiotherapy.

Standards Content (Sample)

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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