ISO 4980:2023
(Main)Benefit-risk assessment for sports and recreational facilities, activities and equipment
Benefit-risk assessment for sports and recreational facilities, activities and equipment
This document specifies methods for a benefit and risk assessment for sports, for recreational and sports facilities including equipment. This document also provides guidance and requirements on benefit and risk assessment within this field. It includes examples for injury thresholds.
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INTERNATIONAL ISO
STANDARD 4980
First edition
2023-05
Benefit-risk assessment for sports and
recreational facilities, activities and
equipment
Reference number
ISO 4980:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 4980:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 4980:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Benefit-risk assessment — Process overview .7
4.1 Assessment team . 7
4.2 Project scope . 7
4.2.1 General . 7
4.2.2 External and internal context . 11
4.2.3 Analytical techniques . 14
4.2.4 Process . 14
5 Assessment of benefits and risks .21
5.1 Quantitative and qualitative analysis and scales . 21
5.2 Benefits assessment . 21
5.2.1 General . 21
5.2.2 Procedure . 21
5.3 Risk assessment . 22
5.3.1 General .22
5.3.2 Criteria for risk acceptability . 22
5.3.3 Hazard identification and analysis . 22
5.3.4 Likelihood analysis .25
5.3.5 Risk evaluation.26
5.4 Risk control measures .26
5.4.1 Differences of information for safety and disclosure of residual risk .26
6 Comparison of benefits and risks .27
6.1 General . 27
6.2 Methodology .28
6.2.1 General .28
6.2.2 Benefit enhancement .29
6.2.3 Risk control .29
7 Documentation .29
7.1 General .29
7.2 Validation .30
7.3 Benefit assessments . 30
7.4 Risk assessments .30
7.5 Safety-related information .30
7.6 Benefit-risk balance . 30
7.7 Documentation .30
8 Performance and evaluation .31
8.1 General . 31
8.2 Periodic evaluation . 31
8.2.1 General . 31
8.2.2 Revision or updating of the benefit-risk assessment . 31
8.2.3 Action . 32
9 Training and competency .32
9.1 General . 32
9.2 Training . 32
9.2.1 General . 32
9.2.2 Content . 33
9.3 Frequency of training . 33
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ISO 4980:2023(E)
9.4 Equivalency to training . 33
9.5 Competency . 33
9.5.1 Persons and teams . 33
9.5.2 Equivalency .34
9.5.3 Organizations .34
Annex A (informative) Examples of severity-of-injury scales .35
Annex B (informative) Risk scoring tools .40
Annex C (informative) Decision-making methods .43
Annex D (informative) Method for determining balance between benefit and risk.45
Annex E (informative) Semi-quantitative benefit methodology example .46
Annex F (informative) UK Play Safety Forum risk-benefit assessment .47
Bibliography .48
iv
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ISO 4980:2023(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 83, Sports and other recreational facilities
and equipment.
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.
v
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---------------------- Page: 5 ----------------------
ISO 4980:2023(E)
Introduction
A system is needed for identifying benefits and hazards and assessing risks related to sport and
recreation for all ages and abilities. In many jurisdictions, there is a requirement for the designers,
builders, owners/operators, including inspectors and maintainers of a sport and other recreational
facilities and equipment, to carry out a risk assessment and, in some cases, to record it.
International Standards have been published on risk assessment and general risk management including
[1] [2] [3]
ISO 31000 , IEC 31010 and ISO 45001 on occupational health and safety These International
Standards were written with the intention of providing methods for managing risk and preventing
work-related injury and ill-health via the elimination of hazards and the minimization of occupational
health and safety (OH&S) risks by taking effective preventive and protective measures. As the sport
and recreation sectors have specific characteristics and face different challenges, there is a need for an
additional International Standard. There is an expectation in sport and recreational activities that the
user is making an implicit trade-off between the benefits and the inherent risks of the activity, including
of the potential for harm.
Risks and benefits only have meaning in relation to the objectives pursued within the context of a
project (i.e. the project scope). Regarding measuring the risks and benefits, any risk analysis should
include at least the following objectives:
— injury and lethality (risk);
— improvement of health and wellbeing in a broad sense (benefit);
— compliance with legal requirements.
It is up to the user to determine the degree of acceptable risks and the minimum benefits to be achieved
regarding the set objectives.
The terms “sports” and “recreation” describe diverse activities and the necessary equipment for all ages
and abilities. For example, camping, hockey, high ropes and challenge course equipment, martial arts,
games with rules such as football (soccer), kiteboarding, summer tobogganing, play spaces, etcetera all
fall within “sports” and “recreation.”
It is recognized that sports and recreation involve numerous stakeholders including, but not limited to,
designers, manufacturers, installers, owner/operators, maintainers, inspectors of sports and recreation
equipment and facilities, and any park rangers, playworkers or activity leaders who may be present at
these venues.
Due to the varied interests of the different stakeholders, a single system of hazard identification and
risk assessment for the sport and recreation sector is not feasible. What can be achieved, however, is to
identify principles and provide guidance on selecting appropriate techniques.
A key issue identified is the differentiation of sports and recreational activities from a work activity.
Sports and recreational activities are designed for the public good; therefore public interests are
paramount. The public good can include the social, physical, psychological health and welfare of the
participant and society. Participation in sport and recreation involves exposure to risk which is not
necessarily a bad thing and can be of benefit to the public good. Exposure to risk in daily life can reduce
[4],[5],[6]
fear and improves the development of human competency. This is to be balanced with the
exclusion of unforeseen or unrecognizable sources of harm. For example, in adventure sports, exposure
to risk is what provides part of the enjoyment. Even in the case of children's play provision, it is now
widely recognized that children seek risky situations. Graduated challenge provides opportunities
for children to develop internal hazard references. Therefore, the age of participants should be a
consideration when assessing benefits and risks.
It is common to conduct a benefit-risk analysis that explicitly brings together the consideration of
benefits as well as the risks of sport and recreation to a single evaluation. This immediately separates
sport and recreation from the world of occupational health and safety where the goal, as noted above, is
generally seen as one of eliminating or minimizing risk.
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ISO 4980:2023(E)
Within sport and recreation, there are many different goals of which prevention of injury is but one.
Using a benefit-risk approach recognizes the need for making trade-offs in achieving a balance that
maximizes the overall social utility and public good. These are not the only considerations, though they
are important ones. Whether provided on a commercial, not-for-profit, or charitable basis, sport and
recreational activities involve an accepted, inherent element of risk and challenge. Taking risks brings
rewards but also dangers.
The range of stakeholders involved in sport and recreation is so diverse, different types of benefit-risk
assessment is needed. Generally, there are three types of assessments that can be used: the generic risk
assessment, the site-specific risk assessment, and the dynamic risk assessment. This document helps
providers of products, activities, and operators of facilities to better understand the risks associated
with their products, activities, and facilities, and to evaluate, implement, and document a suitable
benefit-risk analysis. For example, a generic risk assessment technique can be used to analyse the risks
related to skis, while a site-specific risk assessment can be used by the owner/operator to evaluate
the ski hill; and the skier and the ski instructor are dynamically assessing the risk during the skiing
activity.
Those responsible for reviewing proposed research must ultimately weigh the risks and benefits to
determine whether the relationship between them is acceptable. This process is complicated by the
fact that risks and benefits often cannot be measured on a uniform scale. First, ‘risks and benefits for
subjects may affect different domains of health status’, as when a risk of physical injury is incurred in
an effort to achieve a potential psychological benefit. Second, ‘risks and benefits may affect different
people’; risks are typically borne by the participants in the research, but most of the benefits will be
[7]
experienced by patients in the future .
vii
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INTERNATIONAL STANDARD ISO 4980:2023(E)
Benefit-risk assessment for sports and recreational
facilities, activities and equipment
1 Scope
This document specifies methods for a benefit and risk assessment for sports, for recreational and
sports facilities including equipment. This document also provides guidance and requirements on
benefit and risk assessment within this field. It includes examples for injury thresholds.
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 3864 (all parts), Graphical symbols — Safety colours and safety signs
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
activity
play, recreation or service that engages a user (3.23) and provides benefit (3.2) which can have an
associated risk (3.11)
3.2
benefit
helpful or good effect, or something intended to help
3.3
benefit-risk
concept which acknowledges that in sports and recreation there is an inevitable and inherent trade-off
between the benefits (3.2) of a sport or recreational activity (3.1) and some of the risks (3.11) which it
can pose
Note 1 to entry: In some circumstances exposure to risk may in itself be considered to be a benefit, e.g. the
benefits of risky play in childhood development.
3.4
benefit-risk assessment
BRA
form of risk assessment that considers both risks (3.11) and benefits (3.2) in parallel when making
decisions
Note 1 to entry: Benefit-risk assessment is a balanced approach that involves judgment and is based on clear
values and understandings. Where appropriate it takes account of local circumstances.
1
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ISO 4980:2023(E)
Note 2 to entry: Benefit-risk assessment includes an evaluation of the social, physical, and developmental
considerations of a given activity (3.1).
Note 3 to entry: There can be instances where regulators or governing bodies set thresholds that do not have a
rationale with the BRA but are arbitrary and must be adhered to.
Note 4 to entry: The risk is not always apparent to the user (3.23) and should focus on the harm (3.13) that cannot
be evaluated or determined by the user during an activity.
3.5
competence
ability to apply knowledge and skills to achieve expected results
[SOURCE: ISO/IEC 17024:2012, 3.6]
3.6
external context
external environment in which the organization seeks to achieve its objectives
Note 1 to entry: External context can include:
— the cultural, social, political, legal, regulatory, financial, technological, economic, natural and competitive
environment, whether international, national, regional or local;
— key drivers and trends having impact on the objectives of the organization; and
— relationships with, and perceptions and values of external stakeholders.
[SOURCE: ISO Guide 73:2009, 3.3.1.1]
3.7
internal context
internal environment in which the organization seeks to achieve its objectives
Note 1 to entry: Internal context can include:
— governance, organizational structure, roles and accountabilities;
— policies, objectives, and the strategies that are in place to achieve them;
— the capabilities, understood in terms of resources and knowledge (e.g. capital, time, people, processes,
systems and technologies);
— information systems, information flows and decision-making processes (both formal and informal);
— relationships with, and perceptions and values of internal stakeholders;
— the organization's culture;
— standards, guidelines and models adopted by the organization; and
— form and extent of contractual relationships.
[SOURCE: ISO Guide 73:2009, 3.3.1.2]
3.8
leader
competent person who takes responsibility for people, and is able to lead, guide and supervise an
assigned activity (3.1)
[SOURCE: ISO 21102:2020, 3.8, modified — Note 1 to entry has been removed.]
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ISO 4980:2023(E)
3.9
safe
state of being protected from recognized hazards (3.14) that are likely to cause harm (3.13)
[SOURCE: ISO/TR 20183:2015, 2.1]
3.10
safety
freedom from unacceptable risk (3.11), but not safe (3.8)
Note 1 to entry: Safety is achieved by reducing risk to a tolerable level.
Note 2 to entry: There is no complete absence of risk. In turn, there is no product or system that is without some
risk which shall be reduced to a tolerable risk.
[SOURCE: ISO/TR 20183:2015, 2.2]
3.11
risk
combination of the probability of occurrence of harm (3.13) and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.16), the
occurrence of a hazardous event (3.15) and the possibility to avoid or limit the harm.
Note 2 to entry: The person or team performing the risk assessment should be able to quantify or define the harm
[SOURCE: ISO/IEC Guide 51:2014, 3.9, modified — Note 2 to entry has been added.]
3.12
risk criteria
terms of reference against which the significance of risk (3.11) is evaluated
Note 1 to entry: Risk criteria are based on organizational objectives, and external context (3.6) and internal
context (3.7).
Note 2 to entry: Risk criteria can be derived from standards, laws, policies and other requirements.
[SOURCE: ISO Guide 73:2009, 3.3.1.3]
3.13
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.14
hazard
potential source of harm (3.13)
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.15
hazardous event
event that can cause harm (3.13)
[SOURCE: ISO/IEC Guide 51:2014, 3.3]
3.16
hazardous situation
circumstance in which people, property or the environment is/are exposed to one or more hazards
(3.14)
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
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ISO 4980:2023(E)
3.17
residual risk
risk (3.11) remaining after risk reduction measures (protective measures) (3.36) have been taken
Note 1 to entry: Following risk reduction measures, the residual risk should be less than tolerable risk, thus
providing safety (3.10).
[SOURCE: ISO/IEC Guide 51:2014, 3.8, modified — "(protective measures)" has been added; note 1 to
entry has been added.]
3.18
risk analysis
systematic use of available information to identify hazards (3.14) and to estimate risk (3.11)
3.19
risk evaluation
procedure based on the risk analysis (3.18) to determine whether a tolerable risk (3.11) has been
achieved
3.20
risk assessment
overall process comprising a risk analysis (3.18) and risk evaluation (3.19)
Note 1 to entry: The degree of exposure to risk (3.11) is comprised of the potential severity of the harm (3.13) and
the probability of that harm occurring. In determining the probability of occurrence of harm, the exposure of a
user (3.23) to a hazardous situation (3.16), the possibility of a hazardous event (3.15), and the potential means of
limiting the harm should all be considered.
3.21
intended use
use of a product or system in accordance with the information provided by the supplier
3.22
reasonably foreseeable misuse
foreseeable misuse
use of a product or system in a manner not intended by the supplier, where that manner of misuse can
be anticipated based on predictable human behaviour
Note 1 to entry: In evaluating readily predictable human behaviours, all relevant demographics should be
considered, including, but not limited to, elderly, chil
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4980
ISO/TC 83
Sports and other recreational
Secretariat: DIN
facilities and equipment — Benefit-
Voting begins on:
2023-02-17 risk assessment for sports and
recreational activities
Voting terminates on:
2023-04-14
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, 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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 4980:2023(E)
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. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 4980:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4980
ISO/TC 83
Sports and other recreational
Secretariat: DIN
facilities and equipment — Benefit-
Voting begins on:
risk assessment for sports and
recreational activities
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 4980:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 4980:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Benefit-risk assessment — Process overview . 7
4.1 Assessment team . 7
4.2 Project scope . 7
4.2.1 General . 7
4.2.2 External and internal context . 11
4.2.3 Analytical techniques . 14
4.2.4 Process . 14
5 Assessment of benefits and risks .21
5.1 Quantitative and qualitative analysis and scales . 21
5.2 Benefits assessment . 21
5.2.1 General . 21
5.2.2 Procedure . 21
5.3 Risk assessment . 22
5.3.1 General .22
5.3.2 Criteria for risk acceptability . 22
5.3.3 Hazard identification and analysis . 22
5.3.4 Likelihood analysis .25
5.3.5 Risk evaluation.26
5.4 Risk control measures .26
5.4.1 Differences of information for safety and disclosure of residual risk .26
6 Comparison of benefits and risks .27
6.1 General . 27
6.2 Methodology .28
6.2.1 General .28
6.2.2 Benefit enhancement .29
6.2.3 Risk control .29
7 Documentation .29
7.1 General .29
7.2 Validation .30
7.3 Benefit assessments . 30
7.4 Risk assessments .30
7.5 Safety-related information .30
7.6 Benefit-risk balance . 30
7.7 Documentation .30
8 Performance and evaluation .31
8.1 General . 31
8.2 Periodic evaluation . 31
8.2.1 General . 31
8.2.2 Revision or updating of the benefit-risk assessment . 31
8.2.3 Action . 32
9 Training and competency .32
9.1 General . 32
9.2 Training . 32
9.2.1 General . 32
9.2.2 Content . 33
9.3 Frequency of training . 33
iii
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---------------------- Page: 3 ----------------------
ISO/FDIS 4980:2023(E)
9.4 Equivalency to training . 33
9.5 Competency . 33
9.5.1 Persons and teams . 33
9.5.2 Equivalency .34
9.5.3 Organizations .34
Annex A (informative) Examples of severity-of-injury scales .35
Annex B (informative) Risk scoring tools .40
Annex C (informative) Decision-making methods .43
Annex D (informative) Method for determining balance between benefit and risk .45
Annex E (informative) Semi-quantitative benefit methodology example .46
Annex F (informative) UK Play Safety Forum risk-benefit assessment .47
Bibliography .48
iv
© ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 4980:2023(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 nongovernmental, 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 83, Sports and other recreational facilities
and equipment.
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.
v
© ISO 2023 – All rights reserved
---------------------- Page: 5 ----------------------
ISO/FDIS 4980:2023(E)
Introduction
A system is needed for identifying benefits and hazards and assessing risks related to sport and
recreation for all ages and abilities. In many jurisdictions, there is a requirement for the designers,
builders, owners/operators, including inspectors and maintainers of a sport and other recreational
facilities and equipment, to carry out a risk assessment and, in some cases, to record it.
International Standards have been published on risk assessment and general risk management including
[1] [2] [3]
ISO 31000 , IEC 31010 and ISO 45001 on occupational health and safety These International
Standards were written with the intention of providing methods for managing risk and preventing
work-related injury and ill-health via the elimination of hazards and the minimization of occupational
health and safety (OH&S) risks by taking effective preventive and protective measures. As the sport
and recreation sectors have specific characteristics and face different challenges, there is a need for an
additional International Standard. There is an expectation in sport and recreational activities that the
user is making an implicit trade-off between the benefits and the inherent risks of the activity, including
of the potential for harm.
Risks and benefits only have meaning in relation to the objectives pursued within the context of a
project (i.e. the project scope). Regarding measuring the risks and benefits, any risk analysis should
include at least the following objectives:
— injury and lethality (risk);
— improvement of health and wellbeing in a broad sense (benefit);
— compliance with legal requirements.
It is up to the user to determine the degree of acceptable risks and the minimum benefits to be achieved
regarding the set objectives.
The terms “sports” and “recreation” describe diverse activities and the necessary equipment for all ages
and abilities. For example, camping, hockey, high ropes and challenge course equipment, martial arts,
games with rules such as football (soccer), kiteboarding, summer tobogganing, play spaces, etcetera all
fall within “sports” and “recreation.”
It is recognized that sports and recreation involve numerous stakeholders including, but not limited to,
designers, manufacturers, installers, owner/operators, maintainers, inspectors of sports and recreation
equipment and facilities, and any park rangers, playworkers or activity leaders who may be present at
these venues.
Due to the varied interests of the different stakeholders, a single system of hazard identification and
risk assessment for the sport and recreation sector is not feasible. What can be achieved, however, is to
identify principles and provide guidance on selecting appropriate techniques.
A key issue identified is the differentiation of sports and recreational activities from a work activity.
Sports and recreational activities are designed for the public good; therefore public interests are
paramount. The public good can include the social, physical, psychological health and welfare of the
participant and society. Participation in sport and recreation involves exposure to risk which is not
necessarily a bad thing and can be of benefit to the public good. Exposure to risk in daily life can reduce
[4],[5],[6]
fear and improves the development of human competency. This is to be balanced with the
exclusion of unforeseen or unrecognizable sources of harm. For example, in adventure sports, exposure
to risk is what provides part of the enjoyment. Even in the case of children's play provision, it is now
widely recognized that children seek risky situations. Graduated challenge provides opportunities
for children to develop internal hazard references. Therefore, the age of participants should be a
consideration when assessing benefits and risks.
It is common to conduct a benefit-risk analysis that explicitly brings together the consideration of
benefits as well as the risks of sport and recreation to a single evaluation. This immediately separates
sport and recreation from the world of occupational health and safety where the goal, as noted above, is
generally seen as one of eliminating or minimizing risk.
vi
© ISO 2023 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/FDIS 4980:2023(E)
Within sport and recreation, there are many different goals of which prevention of injury is but one.
Using a benefit-risk approach recognizes the need for making trade-offs in achieving a balance that
maximizes the overall social utility and public good. These are not the only considerations, though they
are important ones. Whether provided on a commercial, not-for-profit, or charitable basis, sport and
recreational activities involve an accepted, inherent element of risk and challenge. Taking risks brings
rewards but also dangers.
The range of stakeholders involved in sport and recreation is so diverse, different types of benefit-risk
assessment is needed. Generally, there are three types of assessments that can be used: the generic risk
assessment, the site-specific risk assessment, and the dynamic risk assessment. This document helps
providers of products, activities, and operators of facilities to better understand the risks associated
with their products, activities, and facilities, and to evaluate, implement, and document a suitable
benefit-risk analysis. For example, a generic risk assessment technique can be used to analyse the risks
related to skis, while a site-specific risk assessment can be used by the owner/operator to evaluate
the ski hill; and the skier and the ski instructor are dynamically assessing the risk during the skiing
activity.
Those responsible for reviewing proposed research must ultimately weigh the risks and benefits to
determine whether the relationship between them is acceptable. This process is complicated by the
fact that risks and benefits often cannot be measured on a uniform scale. First, ‘risks and benefits for
subjects may affect different domains of health status’, as when a risk of physical injury is incurred in
an effort to achieve a potential psychological benefit. Second, ‘risks and benefits may affect different
people’; risks are typically borne by the participants in the research, but most of the benefits will be
[7]
experienced by patients in the future .
vii
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 4980:2023(E)
Sports and other recreational facilities and equipment —
Benefit-risk assessment for sports and recreational
activities
1 Scope
This document specifies methods for a benefit and risk assessment for sports, for recreational and
sports facilities including equipment. This document also provides guidance and requirements on
benefit and risk assessment within this field. It includes examples for injury thresholds.
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 3864 (all parts), Graphical symbols — Safety colours and safety signs
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
activity
play, recreation or service that engages a user (3.23) and provides benefit (3.2) which can have an
associated risk (3.11)
3.2
benefit
helpful or good effect, or something intended to help
3.3
benefit-risk
concept which acknowledges that in sports and recreation there is an inevitable and inherent tradeoff
between the benefits (3.2) of a sport or recreational activity (3.1) and some of the risks (3.11) which it
can pose
Note 1 to entry: In some circumstances exposure to risk may in itself be considered to be a benefit, e.g. the
benefits of risky play in childhood development.
3.4
benefit-risk assessment
BRA
form of risk assessment that considers both risks (3.11) and benefits (3.2) in parallel when making
decisions
Note 1 to entry: Benefit-risk assessment is a balanced approach that involves judgment and is based on clear
values and understandings. Where appropriate it takes account of local circumstances.
1
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ISO/FDIS 4980:2023(E)
Note 2 to entry: Benefit-risk assessment includes an evaluation of the social, physical, and developmental
considerations of a given activity (3.1).
Note 3 to entry: There can be instances where regulators or governing bodies set thresholds that do not have a
rationale with the BRA but are arbitrary and must be adhered to.
Note 4 to entry: The risk is not always apparent to the user (3.23) and should focus on the harm (3.13) that cannot
be evaluated or determined by the user during an activity.
3.5
competence
ability to apply knowledge and skills to achieve expected results
[SOURCE: ISO/IEC 17024:2012, 3.6]
3.6
external context
external environment in which the organization seeks to achieve its objectives
Note 1 to entry: External context can include:
— the cultural, social, political, legal, regulatory, financial, technological, economic, natural and competitive
environment, whether international, national, regional or local;
— key drivers and trends having impact on the objectives of the organization; and
— relationships with, and perceptions and values of external stakeholders.
[SOURCE: ISO Guide 73:2009, 3.3.1.1]
3.7
internal context
internal environment in which the organization seeks to achieve its objectives
Note 1 to entry: Internal context can include:
— governance, organizational structure, roles and accountabilities;
— policies, objectives, and the strategies that are in place to achieve them;
— the capabilities, understood in terms of resources and knowledge (e.g. capital, time, people, processes,
systems and technologies);
— information systems, information flows and decision-making processes (both formal and informal);
— relationships with, and perceptions and values of internal stakeholders;
— the organization's culture;
— standards, guidelines and models adopted by the organization; and
— form and extent of contractual relationships.
[SOURCE: ISO Guide 73:2009, 3.3.1.2]
3.8
leader
competent person who takes responsibility for people, and is able to lead, guide and supervise an
assigned activity (3.1)
[SOURCE: ISO 21102:2020, 3.8, modified — Note 1 to entry has been removed.]
2
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ISO/FDIS 4980:2023(E)
3.9
safe
state of being protected from recognized hazards (3.14) that are likely to cause harm (3.13)
[SOURCE: ISO/TR 20183:2015, 2.1]
3.10
safety
freedom from unacceptable risk (3.11), but not safe (3.8)
Note 1 to entry: Safety is achieved by reducing risk to a tolerable level.
Note 2 to entry: There is no complete absence of risk. In turn, there is no product or system that is without some
risk which shall be reduced to a tolerable risk.
[SOURCE: ISO/TR 20183:2015, 2.2]
3.11
risk
combination of the probability of occurrence of harm (3.13) and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.16), the
occurrence of a hazardous event (3.15) and the possibility to avoid or limit the harm.
Note 2 to entry: The person or team performing the risk assessment should be able to quantify or define the harm
[SOURCE: ISO/IEC Guide 51:2014, 3.9, modified — Note 2 to entry has been added.]
3.12
risk criteria
terms of reference against which the significance of risk (3.11) is evaluated
Note 1 to entry: Risk criteria are based on organizational objectives, and external context (3.6) and internal
context (3.7).
Note 2 to entry: Risk criteria can be derived from standards, laws, policies and other requirements.
[SOURCE: ISO Guide 73:2009, 3.3.1.3]
3.13
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.14
hazard
potential source of harm (3.13)
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.15
hazardous event
event that can cause harm (3.13)
[SOURCE: ISO/IEC Guide 51:2014, 3.3]
3.16
hazardous situation
circumstance in which people, property or the environment is/are exposed to one or more hazards
(3.14)
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
3
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ISO/FDIS 4980:2023(E)
3.17
residual risk
risk (3.11) remaining after risk reduction measures (protective measures) (3.36) h
...
ISO/FDIS 4980:2022 (E)
ISO/TC 83/WG 6
Secretariat: DIN
Date: 2022-12-072023-02-03
Sports and other recreational facilities and equipment — Benefit-
risk assessment for sports, for and recreational and sports
facilities including equipmentactivities
FDIS stage
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ISO/FDIS 4980:2022 2023(E)
© ISO 20222023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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ISO/DIS FDIS 4980:2022 2023(E)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Benefit-risk assessment — Process overview . 7
4.1 Assessment team . 7
4.2 Project scope . 7
4.2.1 General . 7
4.2.2 External and internal context . 11
4.2.3 Analytical techniques . 15
4.2.4 Process . 15
5 Assessment of benefits and risks. 21
5.1 Quantitative and qualitative analysis and scales . 21
5.2 Benefits assessment . 21
5.2.1 General . 21
5.2.2 Procedure . 22
5.3 Risk assessment . 22
5.3.1 General . 22
5.3.2 Criteria for risk acceptability . 23
5.3.3 Hazard identification and analysis . 23
5.3.4 Likelihood analysis . 25
5.3.5 Risk evaluation . 26
5.4 Risk control measures . 26
5.4.1 Differences of information for safety and disclosure of residual risk . 26
6 Comparison of benefits and risks . 27
6.1 General . 27
6.2 Methodology . 28
6.2.1 General . 28
6.2.2 Benefit enhancement . 29
6.2.3 Risk control . 29
7 Documentation . 29
7.1 General . 29
7.2 Validation . 30
7.3 Benefit assessments . 30
7.4 Risk assessments . 30
7.5 Safety-related information . 30
7.6 Benefit-risk balance . 30
7.7 Documentation . 30
8 Performance and evaluation . 31
8.1 General . 31
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ISO/FDIS 4980:2022 2023(E)
8.2 Periodic evaluation. 31
8.2.1 General . 31
8.2.2 Revision or updating of the benefit-risk assessment . 31
8.2.3 Action . 31
9 Training and competency . 32
9.1 General . 32
9.2 Training . 32
9.2.1 General . 32
9.2.2 Content . 32
9.3 Frequency of training . 33
9.4 Equivalency to training . 33
9.5 Competency . 33
9.5.1 Persons and teams . 33
9.5.2 Equivalency . 33
9.5.3 Organizations . 33
Annex A (informative) Examples of severity-of-injury scales . 34
Annex B (informative) Risk scoring tools . 38
Annex C (informative) Decision-making methods . 41
Annex D (informative) Method for determining balance between benefit and risk . 43
Annex E (informative) Semi-quantitative benefit methodology example . 44
Annex F (informative) UK Play Safety Forum risk-benefit assessment . 45
Bibliography . 46
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ISO/DIS FDIS 4980:2022 2023(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 83, Sports and other recreational facilities
and equipment.
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/FDIS 4980:2022 2023(E)
Introduction
A system is needed for identifying benefits and hazards and assessing risks related to sport and
recreation for all ages and abilities. In many jurisdictions, there is a requirement for the designers,
builders, owners/operators, including inspectors and maintainers of a sport and other recreational
facilities and equipment, to carry out a risk assessment and, in some cases, to record it.
International Standards have been published on risk assessment and general risk management including
[1[1],] [2[2] ] [3] [3]
ISO 31000 , IEC 31010 , and ISO 45001 on occupational health and safety, ISO 45001 . These
International Standards were written with the intention of providing methods for managing risk and
preventing work-related injury and ill-health via the elimination of hazards and the minimization of
occupational health and safety (OH&S) risks by taking effective preventive and protective measures. As
the sport and recreation sectors have specific characteristics and face different challenges, there is a need
for an additional International Standard. There is an expectation in sport and recreational activities that
the user is making an implicit trade-off between the benefits and the inherent risks of the activity,
including of the potential for harm.
Risks and benefits only have meaning in relation to the objectives pursued within the context of a project
(i.e. the project scope). Regarding measuring the risks and benefits, any risk analysis should include at
least the following objectives:
— — injury and lethality (risk);
— — improvement of health and wellbeing in a broad sense (benefit);
— — compliance with legal requirements.
It is up to the user to determine the degree of acceptable risks and the minimum benefits to be achieved
regarding the set objectives.
The terms “sports” and “recreation” describe diverse activities and the necessary equipment for all ages
and abilities. For example, camping, hockey, high ropes and challenge course equipment, martial arts,
games with rules such as football (soccer), kiteboarding, summer tobogganing, play spaces, etcetera all
fall within “sports” and “recreation.”
It is recognized that sports and recreation involve numerous stakeholders including, but not limited to,
designers, manufacturers, installers, owner/operators, maintainers, inspectors of sports and recreation
equipment and facilities, and any park rangers, playworkers or activity leaders who may be present at
these venues.
Due to the varied interests of the different stakeholders, a single system of hazard identification and risk
assessment for the sport and recreation sector is not feasible. What can be achieved, however, is to
identify principles and provide guidance on selecting appropriate techniques.
A key issue identified is the differentiation of sports and recreational activities from a work activity.
Sports and recreational activities are designed for the public good; therefore public interests are
paramount. The public good can include the social, physical, psychological health and welfare of the
participant and society. Participation in sport and recreation involves exposure to risk which is not
necessarily a bad thing and can be of benefit to the public good. Exposure to risk in daily life can reduce
[4],[5],[6 [4], [5], [6] ]
fear and improves the development of human competency. . This is to be balanced with the
exclusion of unforeseen or unrecognizable sources of harm. For example, in adventure sports, exposure
to risk is what provides part of the enjoyment. Even in the case of children's play provision, it is now
widely recognized that children seek risky situations. Graduated challenge provides opportunities for
children are to develop internal hazard references. Therefore, the age of participants should be a
consideration when assessing benefits and risks.
It is common to conduct a benefit-risk analysis that explicitly brings together the consideration of benefits
as well as the risks of sport and recreation to a single evaluation. This immediately separates sport and
recreation from the world of occupational health and safety where the goal, as noted above, is generally
seen as one of eliminating or minimizing risk.
Within sport and recreation, there are many different goals of which prevention of injury is but one. Using
a benefit-risk approach recognizes the need for making trade-offs in achieving a balance that maximizes
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ISO/DIS FDIS 4980:2022 2023(E)
the overall social utility and public good. These are not the only considerations, though they are important
ones. Whether provided on a commercial, not-for-profit, or charitable basis, sport and recreational
activities involve an accepted, inherent element of risk and challenge. Taking risks brings rewards but
also dangers.
The range of stakeholders involved in sport and recreation is so diverse, different types of benefit-risk
assessment is needed. Generally, there are three types of assessments that can be used: the generic risk
assessment, the site-specific risk assessment, and the dynamic risk assessment. This document helps
providers of products, activities, and operators of facilities to better understand the risks associated with
their products, activities, and facilities, and to evaluate, implement, and document a suitable benefit-risk
analysis. For example, a generic risk assessment technique can be used to analyse the risks related to skis,
while a site-specific risk assessment can be used by the owner/operator to evaluate the ski hill; and the
skier and the ski instructor are dynamically assessing the risk during the skiing activity.
Those responsible for reviewing proposed research must ultimately weigh the risks and benefits to
determine whether the relationship between them is acceptable. This process is complicated by the fact
that risks and benefits often cannot be measured on a uniform scale. First, ‘risks and benefits for subjects
may affect different domains of health status’, as when a risk of physical injury is incurred in an effort to
achieve a potential psychological benefit. Second, ‘risks and benefits may affect different people’; risks
are typically borne by the participants in the research, but most of the benefits will be experienced by
[7 [7] ]
patients in the future . .
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ISO/FDIS 4980:2023(E)
Sports and other recreational facilities and equipment — Benefit-
risk assessment for sports, for and recreational and sports
facilities, including equipmentactivities
1 Scope
This document specifies methods for a benefit and risk assessment for sports, for recreational and sports
facilities including equipment. This document also provides guidance and requirements on benefit and
risk assessment within this field. It includes examples for injury thresholds.
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 3864 (all parts), Graphical symbols — Safety colours and safety signs
ANSI Z535.4, American National Standard for Product Safety Signs and Labels
ANSI Z535.6, American National Standard for Product Safety Information in Product Manuals,
Instructions, and Other Collateral Materials
43 Terms and definitions
For the purposes of this document, the following terms and definitions 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
activity
play, recreation or service that engages a user (3.23(3.23)) and provides benefit (3.2(3.2)) which can have
an associated risk (3.11(3.11))
3.2
benefit
helpful or good effect, or something intended to help
3.3
benefit-risk
concept which acknowledges that in sports and recreation there is an inevitable and inherent trade-off
between the benefits (3.2(3.2)) of a sport or recreational activity (3.1(3.1)) and some of the risks
(3.11(3.11)) which it can pose
Note 1 to entry: In some circumstances exposure to risk may in itself be considered to be a benefit, e.g. the benefits
of risky play in childhood development.
3.4
benefit-risk assessment
BRA
BRA
form of risk assessment that considers both risks (3.11(3.11)) and benefits (3.2(3.2)) in parallel when
making decisions
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ISO/FDIS 4980:2023(E)
Note 1 to entry: Benefit-risk assessment is a balanced approach that involves judgment and is based on clear values
and understandings. Where appropriate it takes account of local circumstances.
Note 2 to entry: Benefit-risk assessment includes an evaluation of the social, physical, and developmental
considerations of a given activity (3.1(3.1).).
Note 3 to entry: There can be instances where regulators or governing bodies set thresholds that do not have a
rationale with the BRA but are arbitrary and must be adhered to.
Note 4 to entry: The risk is not always apparent to the user (3.23(3.23)) and should focus on the harm (3.13(3.13))
that cannot be evaluated or determined by the user during an activity.
3.5
competence
ability to apply knowledge and skills to achieve expected results
[SOURCE: ISO/IEC 17024:2012, 3.6]
3.6
external context
external environment in which the organization seeks to achieve its objectives
Note 1 to entry: External context can include:
— — the cultural, social, political, legal, regulatory, financial, technological, economic, natural and
competitive environment, whether international, national, regional or local;
— — key drivers and trends having impact on the objectives of the organization; and
— — relationships with, and perceptions and values of external stakeholders.
[SOURCE: ISO Guide 73:2009, 3.3.1.1]
3.7
internal context
internal environment in which the organization seeks to achieve its objectives
Note 1 to entry: Internal context can include:
— — governance, organizational structure, roles and accountabilities;
— — policies, objectives, and the strategies that are in place to achieve them;
— — the capabilities, understood in terms of resources and knowledge (e.g. capital, time, people,
processes, systems and technologies);
— — information systems, information flows and decision-making processes (both formal and
informal);
— — relationships with, and perceptions and values of internal stakeholders;
— — the organization's culture;
— — standards, guidelines and models adopted by the organization; and
— — form and extent of contractual relationships.
[SOURCE: ISO Guide 73:2009, 3.3.1.2]
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ISO/FDIS 4980:2023(E)
3.8
leader
competent person who takes responsibility for people, and is able to lead, guide and supervise an
assigned activity (3.1(3.1))
[SOURCE: ISO 21102:2020, 3.8, modified — Note 1 to entry has been removed.]
3.9
safe
state of being protected from recognized hazards (3.14(3.14)) that are likely to cause harm (3.13(3.13))
[SOURCE: ISO/TR 20183:2015, 2.1]
3.10
safety
freedom from unacceptable risk (3.11(3.11),), but not safe (3.8(3.8))
Note 1 to entry: Safety is achieved by reducing risk to a tolerable level.
Note 2 to entry: There is no complete absence of risk. In turn, there is no product or system that is without some
risk which shall be reduced to a tolerable risk.
[SOURCE: ISO/TR 20183:2015, 2.2]
3.11
risk
combination of the probability of occurrence of harm (3.13(3.13)) and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.16(3.4),), the
occurrence of a hazardous event (3.15(3.3)) and the possibility to avoid or limit the harm.
Note 2 to entry: The person or team performing the risk assessment should be able to quantify or define the harm
[SOURCE: ISO/IEC Guide 51:2014 —, 3.9, modified added— Note 2] to entry has been added.]
3.12
risk criteria
terms of reference against which the significance of risk (3.11(3.11)) is evaluated
Note 1 to entry: Risk criteria are based on organizational objectives, and externalcontext (3.6external context (3.6))
and internal context (3.7(3.7).).
Note 2 to entry: Risk criteria can be derived from standards, laws, policies and other requirements.
[SOURCE: ISO Guide 73:2009, 3.3.1.3]
3.13
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.14
hazard
potential source of harm (3.13(3.13))
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.15
hazardous event
event that can cause harm (3.13(3.13))
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ISO/FDIS 4980:2023(E)
[SOURCE: ISO/IEC Guide 51:2014, 3.3]
3.16
hazardous situation
circumstance in which people, property or the environment is/are exposed to one or more hazards
(3.14(3.14))
[SOURCE: ISO/IEC Guide 51:2014, 3.4]]]
3.17
residual risk
risk (3.11(3.11)) remaining after risk reduction measures (protective measures) (3.36(3.36)) have been
taken
Note 1 to entry: Following risk reduction measures, the residual risk should be less than tolerable risk, thus
providing safety (3.10(3.10).).
[SOURCE: ISO/IEC Guide 51:2014, 3.8, modified — "(protective measures)" has been added; note 1 to
entry has been added.]
3.18
risk analysis
(3.11))
systematic use of available information to identify hazards (3.14(3.14)) and to estimate risk (3.11
3.19
risk evaluation
procedure based on the risk analysis (3.18(3.18)) to determine whether a tolerable risk (3.11(3.11)) has
been achieved
3.20
risk assessment
overall process comprising a risk analysis (3.18(3.18)) and risk evaluation (3.19(3.19))
Note 1 to entry: The degree of exposure to risk (3.11(3.11)) is comprised of the potential severity of the harm
(3.13(3.13)) and the probability of that harm occurring. In determining the probability of occurrence of harm, the
exposure of a user (3.23(3.23)) to a hazardous situation (3.16(3.16),), the possibility of a hazardous event
(3.15(3.15),), and the potential means of limiting the harm should all be considered.
3.21
intended use
use of a product or system in accordance with the information provided by the supplier
3.22
reasonably foreseeable misuse
foreseeable misuse
use of a product or system in a manner not intended by the supplier, where that manner of misuse can
be anticipated based on predicta
...
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