ISO 21448:2022
(Main)Road vehicles — Safety of the intended functionality
Road vehicles — Safety of the intended functionality
This document provides a general argument framework and guidance on measures to ensure the safety of the intended functionality (SOTIF), which is the absence of unreasonable risk due to a hazard caused by functional insufficiencies, i.e.: a) the insufficiencies of specification of the intended functionality at the vehicle level; or b) the insufficiencies of specification or performance insufficiencies in the implementation of electric and/or electronic (E/E) elements in the system. This document provides guidance on the applicable design, verification and validation measures, as well as activities during the operation phase, that are needed to achieve and maintain the SOTIF. This document is applicable to intended functionalities where proper situational awareness is essential to safety and where such situational awareness is derived from complex sensors and processing algorithms, especially functionalities of emergency intervention systems and systems having levels of driving automation from 1 to 5[2]. This document is applicable to intended functionalities that include one or more E/E systems installed in series production road vehicles, excluding mopeds. Reasonably foreseeable misuse is in the scope of this document. In addition, operation or assistance of a vehicle by a remote user or communication with a back office that can affect vehicle decision making is in scope of this document when it can lead to safety hazards. This document does not apply to: — faults covered by the ISO 26262 series; — cybersecurity threats; — hazards directly caused by the system technology (e.g. eye damage from the beam of a lidar); — hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, release of energy and similar hazards, unless directly caused by the intended functionality of E/E systems; and — deliberate actions that clearly violate the system’s intended use, (which are considered feature abuse). This document is not intended for functions of existing systems for which well-established and well-trusted design, verification and validation (V&V) measures exist (e.g. dynamic stability control systems, airbags).
Véhicules routiers — Sécurité de la fonction attendue
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 21448
First edition
2022-06
Road vehicles — Safety of the intended
functionality
Véhicules routiers — Sécurité de la fonction attendue
Reference number
ISO 21448:2022(E)
© ISO 2022
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ISO 21448:2022(E)
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© ISO 2022
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ISO 21448:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Overview and organization of SOTIF activities .11
4.1 General . 11
4.2 SOTIF principles . 11
4.2.1 SOTIF-related hazardous event model . 11
4.2.2 The four scenario areas .12
4.2.3 Sense-Plan-Act model .15
4.3 Use of this document . 16
4.3.1 Flow chart and structure of this document . 16
4.3.2 Normative clauses . 19
4.3.3 Interpretation of tables . 19
4.4 Management of SOTIF activities and supporting processes . 19
4.4.1 Quality management, systems engineering and functional safety . 19
4.4.2 Distributed SOTIF development activities . 20
4.4.3 SOTIF-related element out of context . 20
5 Specification and design .21
5.1 Objectives . 21
5.2 Specification of the functionality and considerations for the design . 21
5.3 System design and architecture considerations . 22
5.4 Performance insufficiencies and countermeasures considerations .23
5.5 Work products . 25
6 Identification and evaluation of hazards .25
6.1 Objectives . 25
6.2 General . 26
6.3 Hazard identification . 26
6.4 Risk evaluation .29
6.5 Specification of acceptance criteria for the residual risk .30
6.6 Work products . 31
7 Identification and evaluation of potential functional insufficiencies and potential
triggering conditions .31
7.1 Objectives . 31
7.2 General . 31
7.3 Analysis of potential functional insufficiencies and triggering conditions . 32
7.3.1 General . 32
7.3.2 Potential functional insufficiencies and triggering conditions related to
planning algorithms .35
7.3.3 Potential functional insufficiencies and triggering conditions related to
sensors and actuators . 35
7.3.4 Analysis of reasonably foreseeable direct or indirect misuse.36
7.4 Estimation of the acceptability of the system's response to the triggering
conditions . 37
7.5 Work products .38
8 Functional modifications addressing SOTIF-related risks .38
8.1 Objectives .38
8.2 General .38
8.3 Measures to improve the SOTIF .38
8.3.1 Introduction .38
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ISO 21448:2022(E)
8.3.2 System modification.39
8.3.3 Functional restrictions .40
8.3.4 Handing over authority . 41
8.3.5 Addressing reasonably foreseeable misuse . 41
8.3.6 Considerations to support the implementation of SOTIF measures . 42
8.4 Updating the input information for “Specification and design” . 42
8.5 Work products . 42
9 Definition of the verification and validation strategy .42
9.1 Objectives . 42
9.2 General . 42
9.3 Specification of integration and testing . 43
9.4 Work products . 45
10 Evaluation of known scenarios .46
10.1 Objectives .46
10.2 General .46
10.3 Sensing verification .46
10.4 Planning algorithm verification . 47
10.5 Actuation verification .48
10.6 Integrated system verification .48
10.7 Evaluation of the residual risk due to known hazardous scenarios .49
10.8 Work products . 50
11 Evaluation of unknown scenarios .50
11.1 Objectives . 50
11.2 General .50
11.3 Evaluation of residual risk due to unknown hazardous scenarios .50
11.4 Work products . 52
11.4.1 Validation results for unknown hazardous scenarios fulfilling objective 11.1 . 52
11.4.2 Evaluation of the residual risk fulfilling objective 11.1 . 52
12 Evaluation of the achievement of the SOTIF .52
12.1 Objectives . 52
12.2 General .53
12.3 Methods and criteria for evaluating the SOTIF . 53
12.4 Recommendation for SOTIF release .54
12.5 Work products .54
13 Operation phase activities .55
13.1 Objectives . 55
13.2 General . 55
13.3 Topics for observation.56
13.4 SOTIF issue evaluation and resolution process . 57
13.5 Work products . 57
Annex A (informative) General guidance on SOTIF .58
Annex B (informative) Guidance on scenario and system analyses .95
Annex C (informative) Guidance on SOTIF verification and validation . 125
Annex D (informative) Guidance on specific aspects of SOTIF . 159
Bibliography .179
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ISO 21448:2022(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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 22, Road vehicles, Subcommittee SC 32,
Electrical and electronic components and general system aspects.
This first edition cancels and replaces the first edition of ISO/PAS 21448:2019, which has been
technically revised.
The main changes are as follows:
— the scope has been extended to include all levels of driving automation;
— the clauses and annexes have been reworked and expanded for clarification and additional guidance;
— the definitions (Clause 3) have been reworked, in particular to clarify the hazard model; and
— Clause 13 has been added to address the operation phase after the function has been activated for
end users.
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.
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ISO 21448:2022(E)
Introduction
The safety of road vehicles is a concern of paramount importance for the road vehicle industry. The
number of automated driving functionalities included in vehicles is increasing. These rely on sensing,
processing of complex algorithms and actuation implemented by electrical and/or electronic (E/E)
systems.
An acceptable level of safety for road vehicles requires the absence of unreasonable risk caused by every
hazard associated with the intended functionality and its implementation, including both hazards due
to failures and due to insufficiencies of specification or performance insufficiencies.
For the achievement of functional safety, ISO 26262-1 defines functional safety as the absence of
unreasonable risk due to hazards caused by malfunctioning behaviour of the E/E system. ISO 26262-3
describes how to conduct a hazard analysis and risk assessment (HARA) to determine vehicle-level
hazards and associated safety goals. The other parts of the ISO 26262 series provide requirements and
recommendations to avoid and control random hardware failures and systematic failures that could
violate safety goals.
For some E/E systems, e.g. systems which rely on sensing the external or internal vehicle environment
to build situational awareness, the intended functionality and its implementation can cause hazardous
behaviour, despite these systems being free from the faults addressed in the ISO 26262 series. Example
causes of such potentially hazardous behaviour include:
— the inability of the function to correctly perceive the environment;
— the lack of robustness of the function, system, or algorithm with respect to sensor input variations,
heuristics used for fusion, or diverse environmental conditions;
— the unexpected behaviour due to decision making algorithm and/or divergent human expectations.
In particular, these factors are relevant to functions, systems or algorithms that use machine learning.
The absence of unreasonable risk resulting from hazardous behaviours related to functional
insufficiencies is defined as the safety of the intended functionality (SOTIF). Functional safety
(addressed by the ISO 26262 series) and the SOTIF are complementary aspects of safety (see A.2 for a
better understanding of the respective scopes of the ISO 26262 series and this document).
To address the SOTIF, measures to eliminate hazards or reduce risks are implemented during the
following phases:
— the specification and design phase;
EXAMPLE 1 Modification of vehicle functionality or of sensor performance requirements, driven by
identified system insufficiencies or by hazardous scenarios identified during the SOTIF activities.
— the verification and validation phase; and
EXAMPLE 2 Technical reviews, test cases with a high coverage of relevant scenarios, injection of potential
triggering conditions, in the loop testing (e.g. SIL: software in the loop / HIL: hardware in the loop / MIL:
model in the loop) of selected SOTIF-relevant scenarios.
EXAMPLE 3 Long-term vehicle testing, test-track vehicle testing, simulation testing.
— the operation phase.
EXAMPLE 4 Field monitoring of SOTIF incidents.
These hazards can be triggered by specific conditions of a scenario, defined as triggering conditions,
which can include reasonably foreseeable misuse of the intended functionality. Additionally, the
interaction with other functions at the vehicle level can lead to hazards (e.g. activation of the parking
brake while the automated driving function is active).
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ISO 21448:2022(E)
Therefore, a proper understanding by the user of the functionality, its behaviour and its limitations
(including the human/machine interface) is essential to ensure safety.
EXAMPLE 5 Lack of driver attention while using a Level 2 automated driving system.
EXAMPLE 6 Mode confusion (e.g. the driver thinks the function is activated when it is deactivated) can
directly lead to a hazard.
NOTE 1 Reasonably foreseeable misuse excludes intentional alterations made to the system’s operation.
Information provided by the infrastructure (e.g. V2X – Vehicle2Everything communication, maps) is
also part of the evaluation of functional insufficiencies if it can have an impact on the SOTIF. See D.4 for
guidance on V2X features.
EXAMPLE 7 For automated valet parking systems, the functionalities of route planning and object detection
could be achieved jointly by the infrastructure and the vehicle.
NOTE 2 Depending on the application, elements of other technologies can be relevant when evaluating the
SOTIF.
EXAMPLE 8 The location and mounting of a sensor on the vehicle can be relevant to avoid noisy sensor output
resulting from vibration.
EXAMPLE 9 The windshield optical properties can be relevant when evaluating the SOTIF of a camera sensor.
It is assumed that the random hardware faults and systematic faults (including hardware and software
faults) of the E/E system are addressed using the ISO 26262 series.
One could interpret the functional insufficiencies addressed in this document as systematic faults.
However, the measures to address these functional insufficiencies are specific to this document and
complementary to the ones described in the ISO 26262 series. Specifically, the ISO 26262 series assumes
that the intended functionality is safe, and addresses E/E system faults that can cause hazards due to
a deviation from the intended functionality. The requirement-elicitation process for the system and its
elements can include aspects of both standards.
Table 1 illustrates how the possible causes of hazardous events map to existing standards.
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ISO 21448:2022(E)
Table 1 — Overview of safety relevant topics addressed by different standards
Source of
Cause of hazardous events Within scope of
hazard
E/E system faults ISO 26262 series
Functional insufficiencies This document
This document
Incorrect and inadequate Human-Machine Interface (HMI) design
(inappropriate user situational awareness, e.g. user confusion,
European Statement of Principles on
System
user overload, user inattentiveness) [1]
human-machine interface
Functional insufficiencies of artificial intelligence-based algorithms This document
System technologies Specific standards
EXAMPLE Eye damage from the beam of a lidar. EXAMPLE IEC 60825
This document
Reasonably foreseeable misuse by the user or by other road par-
ticipants
The ISO 26262 series
Attack exploiting vehicle security vulnerabilities ISO/SAE 21434
This document
Impact from active infrastructure and/or vehicle to vehicle com-
ISO 20077; ISO 26262 series, IEC 61508
munication, and external systems
External
series
factor
This document
The ISO 26262 series
Impact from vehicle surroundings (e.g. other users, passive infra-
ISO 7637-2, ISO 7537-3
structure, weather, electromagnetic interference)
ISO 11452-2, ISO 11452-4, ISO 10605
and other relevant standards
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INTERNATIONAL STANDARD ISO 21448:2022(E)
Road vehicles — Safety of the intended functionality
1 Scope
This document provides a general argument framework and guidance on measures to ensure the safety
of the intended functionality (SOTIF), which is the absence of unreasonable risk due to a hazard caused
by functional insufficiencies, i.e.:
a) the insufficiencies of specification of the intended functionality at the vehicle level; or
b) the insufficiencies of specification or performance insufficiencies in the implementation of electric
and/or electronic (E/E) elements in the system.
This document provides guidance on the applicable design, verification and validation measures, as
well as activities during the operation phase, that are needed to achieve and maintain the SOTIF.
This document is applicable to intended functionalities where proper situational awareness is essential
to safety and where such situational awareness is derived from complex sensors and processing
algorithms, especially functionalities of emergency intervention systems and systems having levels of
[2]
driving automation from 1 to 5 .
This document is applicable to intended functionalities that include one or more E/E systems installed
in series production road vehicles, excluding mopeds.
Reasonably foreseeable misuse is in the scope of this document. In addition, operation or assistance of a
vehicle by a remote user or communication with a back office that can affect vehicle decision making is
in scope of this document when it can lead to safety hazards.
This document does not apply to:
— faults covered by the ISO 26262 series;
— cybersecurity threats;
— hazards dire
...
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