FprCEN ISO/TS 24971-2
(Main)Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (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)
This document provides guidance on how to apply the risk management process of ISO 14971:2019 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and does not alter the risk management requirements specified in ISO 14971.
This document addresses risks specific to machine learning (ML). Those risks can be related to topics such as data management, feature extraction, unwanted bias, information security, training the ML model by an ML algorithm, evaluation and testing of the trained ML model. See Figure 1 for an overview of the relevant terms and their relationship. See Annex A for an explanation of bias.
It is recognized that the ML model can require retraining after a period of use to redefine its parameters. An ML model can learn continuously from patient data and modify their parameters accordingly. The description “continuous(ly) learning” is used throughout this document; the term “adaptive” is sometimes used in other documents. This document also provides examples and suggests strategies for eliminating or controlling these ML-related risks.
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)
Medicinski pripomočki - Navodilo za uporabo ISO 14971 - 2. del: Strojno učenje v umetni inteligenci (ISO/DTS 24971-2:2025)
General Information
Standards Content (Sample)
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.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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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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) Explainability. These medical devices often rely on complex algorithms and large datasets to generate
output. However, the inherent opacity of these algorithms makes it challenging to interpret how specific
conclusions or recommendations are derived. This can lead to difficulties in understanding their
rationale, even by well-trained clinicians and other healthcare personnel, and certainly by individuals
without specialist knowledge.
Many different AI-based technologies and algorithms exist today, including decision trees, genetic algorithms
[4]
and deep learning-based technologies such as generative AI and neural networks. ISO/IEC 22989 and
[6]
ISO/IEC 23894 provide general guidance on AI concepts, terminology and risk management, but they do
not specifically address the application of AI to medical devices. It is noted that “risk” is defined in these
[2]
documents as the effect of uncertainties on objectives (see also ISO 31000 ). This definition is useful for
organizational or business risk management. The term “risk” used in the healthcare sector is different and
is defined in ISO 14971:2019 as the combination of the probability of occurrence of harm and the severity of
that harm.
Figure 1 — Concept development, training and testing stages of the ML model
and its relationship with the ML algorithm, the training data and the test data
This document focuses on machine learning (ML) techniques and is restricted to ML-enabled medical devices
(MLMD). Machine learning is considered a subset of AI that involves an ML model and an ML algorithm. See
Figure 1. The ML model and the ML algorithm are the results of the concept development for a new MLMD,
together with acceptance criteria for the eventual MLMD. It is important that the acceptance criteria are
established at the start as part of concept development and not at the end of the MLMD development. After
concept development, the ML model is trained by using an ML algorithm enabling it to learn patterns from
training data without being explicitly programmed. Next, the trained ML model is applied to test data to
v
ISO/DTS 24971-2:2025(en)
verify its performance. The training data and the test data are different (disjoint) sets. They can be actual
patient data or synthetic data, i.e. data created to simulate a patient for training or testing purposes. The
tested ML model can then be applied to new patient data in a clinical setting. More information on MLMD
[21] [23] [17][18]
can be found in IMDRF documents N67 and N88 and in guidance documents from FDA, Health
Canada and MHRA.
It is recognized that the ML model can require retraining after a period of use to redefine its parameters. An
ML model can learn continuously from patient data and modify their parameters accordingly. The description
“continuous(ly) learning” is used throughout this document, whereas the word “adaptive” is sometimes used
in other documents.
All medical devices come with inherent risks. Manufacturers are required to demonstrate that their medical
devices do not pose unacceptable risks, and that the benefits of the intended use outweigh the overall
residual risk. ISO 14971 details how manufacturers can identify, assess and control risks to protect the
patients, the users and other persons as well as property (for example objects, data, other equipment) and
the environment. This includes risks related to data and systems security and cybersecurity. Guidance on
[2] [11]
the application of ISO 14971 is provided in document ISO/TR 24971 . Additionally, IEC 80001-1 and
[12]
IEC/TR 80002-1 address software internal to a medical device that can support AI or ML.
This document was developed to provide specific guidance on the application of ISO 14971 to MLMD. It does
not provide a new risk management process, nor does it expand the requirements of ISO 14971. This document
addresses risks related to machine learning and topics such as data management, feature extraction,
unwanted bias, information security, training the ML model by an ML algorithm, evaluation and testing of the
[14]
trained ML model. See Annex A for an explanation of bias. The report AAMI TIR34971 provided valuable
input for this document.
vi
FINAL DRAFT Technical Specification ISO/DTS 24971-2:2025(en)
Medical devices — Guidance on the application of ISO 14971 —
Part 2:
Machine learning in artificial intelligence
1 Scope
This document provides guidance on risks specific to machine learning (ML) and how to apply the risk
management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be
used in conjunction with ISO 14971.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14971:2019, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971:2019 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
bias
systematic difference in treatment of certain objects, people, or groups in comparison to others
Note 1 to entry: Treatment is any kind of action, including perception, observation, representation, prediction or
decision.
[7]
[SOURCE: ISO/IEC TR 24027:2021, 3.2.2 ]
3.2
explainability
property of a system to express important factors influencing the system’s results in a way that humans can
understand
Note 1 to entry: It is intended to answer the question “Why?” without actually attempting to argue that the course of
action that was taken was necessarily optimal.
[4]
[SOURCE: ISO/IEC 22989:2022, 3.5.7 , modified — “AI system” was changed to “system”.]
3.3
machine learning
ML
function of a system that can learn from input data instead of strictly following a set of specific instructions
Note 1 to entry: Machine learning focuses on prediction based on known properties learned from the input data.
ISO/DTS 24971-2:2025(en)
[13]
[SOURCE: AAMI TIR66:2017 , 3.19]
3.4
machine learning algorithm
ML algorithm
algorithm to determine parameters of a machine learning model (3.5) from data according to given criteria
[4]
[SOURCE: ISO/IEC 22989:2022, 3.3.6 , modified — The example was removed.]
3.5
machine learning model
ML model
logical representation of a system that generates predictions based on input data
Note 1 to entry: A machine learning model results from training (3.9) based on a machine learning algorithm (3.4).
[4]
Note 2 to entry: Adapted from ISO/IEC 22989:2022, 3.1.23 and 3.3.7 .
3.6
machine learning-enabled medical device
ML-enabled medical device
MLMD
medical device that utilizes machine learning (3.3)
Note 1 to entry: MLMD can involve multiple ML models and multiple ML algorithms (3.4).
3.7
overfitting
creating a model that fits the training data (3.10) too precisely and fails to generalize on new data
Note 1 to entry: Overfitting can occur because the trained model has learned from non-essential features in the
training data (i.e. features that do not generalize to useful outputs), because of excessive noise in the training data (e.g.
excessive number of outliers) or because the model is too complex for the training data.
Note 2 to entry: Overfitting can be identified when there is a significant difference between errors measured on
training data and on separate test data. The performance of overfitted models is especially impacted when there is a
significant mismatch between training data and new data.
Note 3 to entry: See Figure 2 for a graphical comparison with underfitting (3.12).
[5]
[SOURCE: ISO/IEC 23053:2022, 3.1.4 , modified — In the definition, “which” was changed to “that”; in
Note 1 to entry, “because of” was added; in Note 2 to entry, “separate test and validation data” was changed
to “separate test data”, and “production data” was changed to “new data”; Note 3 to entry was added.]
3.8
test data
data used to assess the performance of the machine learning model (3.5)
Note 1 to entry: Test data is disjoint from training data (3.10).
[4]
[SOURCE: ISO/IEC 22989:2022, 3.2.14 , modified — The preferred term “evaluation data” was removed; in
the definition, “a final model” was changed to “the machine learning model”; “validation data” was deleted
from Note 1 to entry.]
3.9
training
process to determine or to improve the parameters of a machine learning model (3.5), based on a machine
learning algorithm (3.4), by using training data (3.10)
[4]
[SOURCE: ISO/IEC 22989:2022, 3.3.15 , modified — The admitted term “model training” was removed.]
ISO/DTS 24971-2:2025(en)
3.10
training data
data used to train a machine learning model (3.5)
[4]
[SOURCE: ISO/IEC 22989:2022, 3.3.16 ]
3.11
transparency
property of a system that appropriate information about the system is made available to relevant
stakeholders
Note 1 to entry: Appropriate information for system transparency can include aspects such as features, performance,
residual risks, limitations, components, procedures, measures, design goals, design choices and assumptions, data
sources and labelling protocols.
Note 2 to entry: Inappropriate disclosure of some aspects of a system can violate security, privacy or confidentiality
requirements.
[4]
[SOURCE: ISO/IEC 22989:2022, 3.5.15 , modified — “residual risks” was added in Note 1 to entry.]
3.12
underfitting
creating a model that does not fit the training data (3.10) closely enough and produces incorrect predictions
on new data
Note 1 to entry: Underfitting can occur when features are poorly selected, when there is insufficient training time or
when the model is too simple to learn from large training data due to limited model capacity (i.e. expressive power).
Note 2 to entry: See Figure 2 for a graphical comparison with overfitting (3.7).
[5]
[SOURCE: ISO/IEC 23053:2022, 3.1.5 , modified — In Note 1 to entry, “when there is” was added; Note 1 to
entry was added.]
a) Underfitting b) Good fit c) Overfitting
Key
training data
model prediction
Figure 2 — Fit of the ML model on the training data
4 General requirements for risk management system
4.1 Risk management process
ISO 14971 specifies a process for risk management of medical devices. This process also applies to ML-enabled
medical devices. The process covers the identification of hazards and hazardous situations, the estimation
and evaluation of the associated risks, the need for risk control, the evaluation of overall residual risk and the
production and post-production activities for monitoring the effectiveness of the risk control measures.
ISO/DTS 24971-2:2025(en)
4.2 Management responsibilities
ISO 14971 requires top management to:
a) provide adequate resources;
b) assign competent personnel;
c) define and document a policy for establishing the criteria for risk acceptability; and
d) review the suitability of the risk management process to ensure its continuing effectiveness.
[2]
There is no specific guidance for MLMD in addition to what is provided in ISO/TR 24971 .
4.3 Competence of personnel
ISO 14971 requires that persons performing risk management tasks are competent and, where appropriate,
have knowledge of and experience with the particular medical device, its intended use, the technologies
involved, and the risk management techniques employed.
For MLMD specifically, this knowledge should span the appropriate parts of the MLMD life cycle. This can
include general knowledge about the training data and test data used for the MLMD, awareness of the data
quality, understanding of the context of the data and knowledge of what the data actually mean in clinical
practice.
The team performing the risk management tasks can require:
a) individuals with an understanding of good machine learning practices, who are trained on ML model and
[9]
ML algorithm development to identify ways in which the MLMD can fail (see IEC 62304 );
b) individuals trained on algorithm testing and validation to identify verification methods for software risk
control measures for the MLMD;
c) individuals with knowledge of information technology (IT) to identify risks and risk control measures
related to the computing platforms (when applicable) where the MLMD is to be installed and used,
including the security risk control measures for MLMD connected to the internet or to other equipment;
d) individuals trained on usability engineering (human factors engineering) in the context of the MLMD
[10]
use in accordance with IEC 62366-1 , including how transparency and explainability can affect the
MLMD use (e.g. the potential for bias in interpreting the output);
e) individuals with knowledge of the clinical workflow for the MLMD, understanding of the environment in
which the MLMD is to be used, understanding of the interactions of the MLMD with medical practitioners
and patients, and the capability to evaluate the relevance of the results produced by the MLMD in clinical
practice; and
f) individuals with an understanding of good data management practices to identify risks related to data
management, including data integrity, quality of training data and test data (e.g. data robustness, data
fitness to the ML model and free of unintended bias), and data privacy.
NOTE An explanation of bias is given in Annex A.
4.4 Risk management plan
ISO 14971 requires the manufacturer to establish a risk management plan that includes:
a) the scope of the risk management activities;
b) the assignment of responsibilities and authorities;
c) requirements for the review of risk management activities;
d) the criteria for risk acceptability;
ISO/DTS 24971-2:2025(en)
e) the method to evaluate overall residual risk;
f) activities for verification of the implementation and effectiveness of risk control measures; and
g) activities to collect and review production and post-production information.
Specifically for MLMD and in relation to the post-production activities, the manufacturer should consider the
need for monitoring the MLMD performance and the need for updating the MLMD or retraining the ML model.
If monitoring the MLMD performance is considered necessary for safety, the risk management plan should
include the methods and processes for such monitoring and which data are to be collected and reviewed to
support this monitoring. If updating the MLMD or retraining the ML model is considered necessary for the
purpose of managing risk, the risk management plan should include the criteria for initiating an update or
retraining, the frequency of applying those criteria (occasionally, after a set period or continuously) and the
planned activities in the update or retraining process itself. These activities may further include software
maintenance and provisions for returning the MLMD to a previous version.
NOTE Retraining the ML model and returning the MLMD to a previous version can be subject to regulatory
[1]
requirements (see ISO 13485:2016, 7.3.9 and 8.2.3 ).
EXAMPLE 1 Methods for monitoring the MLMD performance, including periodic testing with new test data, to verify
that the MLMD continues to perform as intended.
EXAMPLE 2 Processes for collecting specific data from reported complaints, processes for collecting necessary input
data (e.g. required data input fields to be filled by users before the MLMD can operate).
4.5 Risk management file
ISO 14971 requires the manufacturer to establish and maintain a risk management file. The risk management
file contains the results produced by the risk management process as well as traceability from each identified
hazard to the risk analysis, the risk evaluation, the implementation and verification of risk control measures
and the results of evaluation of the residual risk.
[2]
There is no specific guidance for MLMD in addition to what is provided in ISO/TR 24971 .
5 Risk analysis
5.1 Risk analysis process
ISO 14971 requires the manufacturer to perform risk analysis for the particular medical device and to record
the results of the planned risk analysis activities in the risk management file. The techniques that support risk
[2]
analysis (see ISO/TR 24971:2020, Annex B ) can also be applied to ML-enabled medical devices.
5.2 Intended use and reasonably foreseeable misuse
ISO 14971 requires the manufacturer to document a clear description of the medical device, its intended use
and the reasonably foreseeable misuse. It is emphasized that reasonably foreseeable misuse includes use error,
for example related to lack of transparency. Questions related to MLMD use that can assist in identifying
hazards and characteristics related to safety are given in Annex C.
5.3 Identification of characteristics related to safety
ISO 14971 requires the manufacturer to identify the characteristics of the medical device that can affect safety.
[2]
ISO/TR 24971:2020, Annex A provides an extensive list of questions that can assist the manufacturer in
identifying those characteristics. Additional questions that are specific to properties of MLMD are listed
ISO/DTS 24971-2:2025(en)
in Annex C of this document. Further guidance on the characteristics of software related to the safety of
[12]
medical devices is given in IEC/TR 80002-1 .
[15]
NOTE ASME report provides considerations that can be useful for risk management of MLMD. For example, a
definition of the context of use including the role and scope of the ML model, an assessment of the risks associated with
the MLMD, the influence that the MLMD results can have on clinical decisions.
5.4 Identification of hazards and hazardous situations
ISO 14971 requires the manufacturer to identify and document known and foreseeable hazards associated
with the medical device based on the intended use, reasonably foreseeable misuse and the characteristics
related to safety in both normal and fault conditions as well as the hazardous situations that can results from
each identified hazard.
The hazards and hazardous situations that can occur for medical devices in general can also occur for MLMD.
[2]
The questions in ISO/TR 24971:2020, Annex A and in Annex C of this document can help the manufacturer
to understand the factors affecting the sequence of events and contributing to hazardous situations. Annex B
of this document provides several examples of characteristics related to safety, reasonably foreseeable
sequences or combinations of events, hazardous situations and possible harm in addition to those given in
ISO 14971:2019, Annex C.
5.5 Risk estimation
ISO 14971 requires the manufacturer to perform risk estimation. Factors to consider in the risk estimation for
MLMD include the following.
a) In cases where the probability of occurrence of harm cannot be estimated (which can be the case for
some ML-related risks), the risk should be estimated based on the severity of possible harm alone.
b) The risks can be influenced by factors such as the reliability and usability of the hardware and other IT
components. These factors can complicate the estimation of the probability of occurrence of harm.
c) Additional activities such as usability evaluations (including identification and analysis of use error) and
quality assessment of the training data and the test data (e.g. for being representative of the expected
patient data) can be needed to improve the risk estimation.
6 Risk evaluation
ISO 14971 requires the manufacturer to evaluate all risks associated with the medical device and to determine
if each risk is acceptable or not. There is no specific guidance for ML-enabled medical devices in addition to
[2]
what is provided in ISO/TR 24971 .
7 Risk control
7.1 Risk control option analysis
ISO 14971 requires the manufacturer to reduce the risks associated with the medical device to acceptable
levels and to consider one or more risk control options in the following order of priority:
a) inherently safe design and manufacture;
EXAMPLE 1 Choice and design of the ML algorithm; data quality assurance including data quality metrics;
verification of completeness, correctness and consistency of the training data and the test data; verification that
the training data are separated (sequestered) from the test data; design of the user interface and the data entry
fields such that only realistic data are accepted; procedures to control access to data and authorization to handle
or modify the data.
b) protective measures in the medical device itself or in the manufacturing process;
ISO/DTS 24971-2:2025(en)
EXAMPLE 2 Operational risk control; human oversight with intervention mechanisms; cross validation of
MLMD output using evaluation metrics; alarm signals to the user; measures to minimize the impact of connectivity
loss to remote servers or cloud services.
NOTE 1 To reduce the level of experimenter’s bias (see Reference [26]), the data collection process can include a
blind analysis in which information affecting the outcome is withheld from the MLMD developers.
c) information for safety and, where appropriate, training to users.
EXAMPLE 3 Hand-off strategy when control is passed from the MLMD to the user; instructions for monitoring
and maintaining user skills and expertise; on-screen information and guidance; ensuring transparency of
warnings and precautions.
NOTE 2 Different types and sources of bias are discussed in Annex A.
NOTE 3 Several examples of risks and potential risk control measures are given in Annex B.
[12]
NOTE 4 Guidance on risk control measures for medical device software is given in IEC/TR 80002-1 .
Elements of explainability can be incorporated into the information for safety, such as information that
highlights the importance of accuracy and format of specific patient data as part of the input for the MLMD.
Differences in MLMD performance can relate to the selection of training data from specific patient groups,
leading to differences in performance for other patient groups. The manufacturer can decide to restrict the
intended use based on such differences in performance.
7.2 Implementation of risk control measures
ISO 14971 requires the implementation of the selected risk control measures, the verification of their
implementation and the verification of their effectiveness. The risk management plan specifies how these
distinct verification activities are performed. Additional considerations for ML-enabled medical devices
include the following.
a) Testing the ML model (see Figure 1) can be used as verification of the effectiveness of the risk control
measures that are implemented in the MLMD.
b) Synthetic data can be used in testing under simulated use conditions to verify that a risk control measure
implemented for a certain type of hazard is effective (see Reference [27]). The type of hazard is not
limited to bias.
c) To test for potential demographic bias in a diagnostic system, a patient record can be submitted to the
system and the system’s diagnosis noted. A patient record with synthetic data can then be created
by changing the original patient data (e.g. race, age or gender) in the medical record used in the ML
model and then comparing the results. Although some medical conditions are dependent on the patient
demographics, this is a way to detect potential bias in the data.
d) To manage the update process of the MLMD, risk control measures can include provisions for returning
the MLMD to a previous version. The effectiveness of this process can be verified by simulation of the
scenarios for returning the MLMD to a previous version and verification that the restored version
performs as specified by the manufacturer.
e) Usability evaluation can be used in the verification of the effectiveness of risk control measures, for
example that an intervention feature during human oversight is effective, or that the transparency of
the steps performed by the MLMD is sufficient.
7.3 Residual risk evaluation and subsequent steps
ISO 14971:2019, 7.3 to 7.6 define the requirements for residual risk evaluation, benefit-risk analysis, risks
arising from risk control measures and completeness of risk control. There is no specific guidance for MLMD
[2]
in addition to what is provided in ISO/TR 24971 .
ISO/DTS 24971-2:2025(en)
8 Evaluation of overall residual risk
8.1 General considerations for MLMD
ISO 14971 requires the manufacturer to evaluate the overall residual risk in relation to the benefits of the
intended use of the medical device, using the method and the criteria for the acceptability of the overall
residual risk as defined in the risk management plan.
[2]
ISO/TR 24971 provides guidance on a comprehensive evaluation of the benefits and the overall residual
risk. Additional considerations for ML-enabled medical devices include the following.
a) The rigour of any justifications in the evaluation of the overall residual risk should reflect the complexity
of the use cases considered and the level of experience with the MLMD and its intended use. The
acceptable range of the MLMD performance should be identified and documented to support post-
production activities.
b) The level of autonomy of the MLMD should be evaluated. See Annex D of this document and also
[8]
IEC/TR 60601-4-1 . It is noted that machine learning and autonomy can provide benefit by improving
patient management. However, a high level of autonomy can reduce the situational awareness of the
user and the ability of the user to intervene when hazardous situations occur.
c) The user interface should be evaluated as part of the usability evaluation. Use-related residual risks
should be evaluated for unwanted bias. Such risks can relate to transparency, understandability and over-
trust. Sometimes high risk related to a complex user interface can be acceptable in view of additional
[10]
benefits that such MLMD can offer. See 5.3, 5.4 and IEC 62366-1 .
d) The introduction of novel or innovative technologies can represent significant changes in the current
state of the art and in current medical practice (sometimes referred to as the “standard of care”).
Therefore, the degree of novelty or innovation of the MLMD should be analysed and included in the
evaluation of overall residual risk.
8.2 Disclosure of significant residual risks
ISO 14971 requires the manufacturer to inform users of significant residual risks and to include the necessary
information in the accompanying documentation in order to disclose those residual risks. For MLMD, this
disclosure should include information on the transparency and explainability of the ML-related residual risks.
The information should be adjusted appropriately for the users of the MLMD.
Transparency can be documented in the form of stating performance specifications and limitations for the
MLMD, in particular in relation to the training data and the potential for differences in the MLMD performance.
For example, differences can relate to the selection of training data from specific patient groups, leading to
differences in performance for other patient groups. Information on such differences should be disclosed.
[10]
The transparency of the MLMD can be evaluated by a usability engineering process (see IEC 62366-1 ).
Explainability should include the decisions and predictions made by the MLMD and, where possible,
information regarding the features that are used and weighted by the ML algorithm in the determination and
optimization of the ML model parameters. Where this is not possible, full justification should be made and
appropriate risk control measures should be established. Explainability of the information can be evaluated
[10]
by a usability engineering process (see IEC 62366-1 ).
[17][18]
NOTE Further information on transparency can be found in guidance documents from FDA, Health Canada
and MHRA.
9 Risk management review
ISO 14971 requires the manufacturer to review the execution of the risk management plan before commercial
distribution of the medical device. This review shall ensure that the risk management plan has been
appropriately implemented; that the overall residual risk is acceptable; and that appropriate methods are in
ISO/DTS 24971-2:2025(en)
place to collect and review information in the production and post-production phases. There is no specific
[2]
guidance for ML-enabled m
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