FprCEN ISO/TS 24971-2

SLOVENSKI STANDARD
01-oktober-2025
Medicinski pripomočki - Navodilo za uporabo ISO 14971 - 2. del: Strojno učenje v
umetni inteligenci (ISO/DTS 24971-2:2025)
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in
artificial intelligence (ISO/DTS 24971-2:2025)
Medizinprodukte- Leitfaden zur Anwendung von ISO 14971- Teil 2: Maschinelles Lernen
in der künstlichen Intelligenz (ISO/DTS 24971-2:2025)
Dispositifs médicaux - Recommandations pour l'application de l'ISO 14971 - Partie 2:
Apprentissage automatique dans le cadre de l'intelligence artificielle (ISO/DTS 24971-
2:2025)
Ta slovenski standard je istoveten z: FprCEN ISO/TS 24971-2
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
Technical
Specification
ISO/DTS 24971-2
ISO/TC 210
Medical devices — Guidance on the
Secretariat: ANSI
application of ISO 14971 —
Voting begins on:
2025-08-28
Part 2:
Machine learning in artificial
Voting terminates on:
2025-11-20
intelligence
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
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ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 24971-2:2025(en) © ISO 2025

ISO/DTS 24971-2:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO/DTS 24971-2:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for risk management system . 3
4.1 Risk management process . .3
4.2 Management responsibilities .4
4.3 Competence of personnel .4
4.4 Risk management plan .4
4.5 Risk management file .5
5 Risk analysis . 5
5.1 Risk analysis process .5
5.2 Intended use and reasonably foreseeable misuse .5
5.3 Identification of characteristics related to safety .5
5.4 Identification of hazards and hazardous situations .6
5.5 Risk estimation .6
6 Risk evaluation . 6
7 Risk control . 6
7.1 Risk control option analysis . .6
7.2 Implementation of risk control measures .7
7.3 Residual risk evaluation and subsequent steps .7
8 Evaluation of overall residual risk . 8
8.1 General considerations for MLMD .8
8.2 Disclosure of significant residual risks .8
9 Risk management review . 8
10 Production and post-production activities . 9
10.1 General .9
10.2 Information collection .10
10.3 Information review .10
10.4 Actions .10
Annex A (informative) Explanation of bias .11
Annex B (informative) Examples of hazards and hazardous situations . 14
Annex C (informative) Identification of hazards and characteristics related to safety . 19
Annex D (informative) Considerations for MLMD having a level of autonomy .28
Bibliography .30

iii
ISO/DTS 24971-2:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with Technical
Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62A, Common aspects
of medical equipment, software, and systems, and with the European Committee for Standardization (CEN)
Technical Committee CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical
devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
A list of all parts in the ISO 24971 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DTS 24971-2:2025(en)
Introduction
Artificial intelligence (AI) is rapidly evolving and can bring advantages to healthcare. These advantages can
be related to improved benefits for the patient, improved efficiencies in clinical workflows and improvement
in the management of healthcare itself. However, the implementation of new technologies such as AI can also
present new risks and can, for example, jeopardize patient safety, affect privacy and security, influence user
actions, undermine trust in healthcare or adversely affect the management of healthcare.
[16]
The safety and effectiveness of AI in medical devices was explored in an AAMI-BSI document , which
identified three ways in which AI-based medical devices differed from “traditional” (non-AI) medical devices:
a) Training. These medical devices can process large amounts of data and learn from these data to improve
their results. Thus, they can have positive effects on patient health within the scope of the intended use
of the medical device.
b) Level of autonomy. These medical devices can have the ability to generate different treatment options,
select the best option based on a trained model and execute the selected option (see for example
[8]
IEC/TR 60601-4-1 ). These steps can be performed with reduced or even without direct user action,
but only with human oversight.
c) Expla
...