ISO 4980:2023

INTERNATIONAL ISO
STANDARD 4980
First edition
2023-05
Benefit-risk assessment for sports and
recreational facilities, activities and
equipment
Reference number
© 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
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
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
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
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
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
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.
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.]
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]
3.17
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, children, and persons with disabilities.
Note 2 to entry: In the context of consumer safety (3.10), "reasonably foreseeable use" is often used to encompass
both intended use (3.21) and reasonably foreseeable misuse.
3.23
user
ultimate organization or person engaged in the use of a product, facility or an activity (3.1)
Note 1 to entry: The user can be a parent, legal guardian, qualified caregiver, or another decision-maker where
consent is required.
3.24
inspection
act of careful examination or scrutiny to identify hazards (3.14), and hazardous situations (3.16) and to
evaluate compliance with regulations, codes, and standards
Note 1 to entry: Inspection should include, but not be limited to, consideration of hazards that can emerge
during or as a result of intended operation, reasonably foreseeable misuse (3.22), vandalism, aging of the product/
environment, and weather conditions.
3.25
manufacturer
party responsible for the design or fabrication of a portion or all of a product intended for a consumer
3.26
installer
party responsible for the assembly or installation, or both, of a product to its final configuration
intended by the manufacturer (3.25) and destined for use by a consumer
Note 1 to entry: The installer makes the product ready to use, brings it into the market and has the same
responsibility as the manufacturer; they may even combine several products to a system and act on behalf of the
manufacturer.
3.27
operator
person(s) or organization(s) who allow a product to be used
Note 1 to entry: An operator may implement an active role as a designated supervisor during use.
3.28
protective device
apparatus, that blocks, shields, or otherwise prevents access to a hazard (3.14) or reduces the degree of
harm (3.13) that can be caused by a hazard
EXAMPLE A guard.
Note 1 to entry: A protective device can be an element such as a railing.
3.29
graduated challenge
activity (3.1) that tests users’ (3.23) physical, mental, emotional or social skills to achieve a given,
intended outcome
Note 1 to entry: Based on the ability of the user, there can be circumstances where a user is presented with
hazards (3.14) that shall be eliminated or reduced for the intended user group and unintended users should be
warned away. The user group can be identified by age or ability within the appropriate standard.
3.30
user information
instructions, warning (3.31) labels, or other documentation provided by the manufacturer (3.25)
regarding use and maintenance requirements for the product, as well as issues of potential residual risk
(3.17) that can be related to aging of the product or skill of the user (3.23)
Note 1 to entry: This documentation can be provided by the manufacturer prior to purchase, installation, or
acquisition of the product by the owner or operator (3.27), or both. The documentation should be available to the
user prior to initial use.
Note 2 to entry: Information should be provided in a clear and understandable language. Where provided as
graphical symbols or signage, this shall be clearly visible and understandable by the user.
3.31
warning
notice or communication to indicate a potentially hazardous situation (3.16) that if not avoided can
result in risk (3.11)
Note 1 to entry: "Warning", along with "Danger", "Caution", and "Notice" are keywords whose meaning is defined
in ANSI Z535.4. These keywords are used in safety (3.10) labels and follow specific requirements.
3.32
life-threatening injury
injury to any part of the human body which is severe or resulting in permanent impairment that would
be categorized as abbreviated injury scale (AIS) of 4 or greater
[SOURCE: ISO/TR 20183:2015, 2.33, modified — "(severe with survival probable)" has been removed.]
3.33
debilitating injury
injury that diminishes or weakens the human body and has a legacy of greater than one month and that
could be categorized as abbreviated injury scale (AIS) of 3
Note 1 to entry: Debilitating injuries would include requiring surgery concussions that require removal from
play to medical attention.
[SOURCE: ISO/TR 20183:2015, 2.34 modified — "(serious, but not life-threatening)" has been removed.]
3.34
serious injury
acute physical injury requiring medical or surgical treatment or under the supervision of a qualified
doctor or nurse provided in a hospital or clinic and includes injuries such as burns, fractures,
lacerations, internal injury, injury to organ, concussion, internal bleeding, etc. that can be categorized
as abbreviated injury scale (AIS) of 3
Note 1 to entry: All evaluations shall be considered in the light of the age of the user (3.23).
[SOURCE: ISO/TR 20183:2015, 2.35, modified — "that can be categorized as abbreviated injury scale
(AIS) of 3" has been added; in note 1 to entry, "have to" has been changed to "shall".]
3.35
inherently safe design
measures taken to eliminate hazards (3.14) and/or to reduce risks (3.11) by changing the design or
operating characteristics of the product or system
[SOURCE: ISO/IEC Guide 51:2014, 3.5]
3.36
risk reduction measure
protective measure
action or means to eliminate hazards (3.14) or reduce risks (3.11)
EXAMPLE Inherently safe design (3.35); protective devices (3.28); personal protective equipment; information
for use and installation; organization of work; training; application of equipment; supervision.
[SOURCE: ISO/IEC Guide 51:2014, 3.13]
3.37
risk source
element which alone or in combination has the intrinsic potential to give rise to risk (3.11)
Note 1 to entry: A risk source can be tangible or intangible.
[SOURCE: ISO 31000:2018, 3.4, modified — "intrinsic" has been added; note 1 to entry has been added.]
3.38
surface
point of contact between the user (3.23) and an element in an activity (3.1) whose properties that can
create a hazardous situation (3.16)
Note 1 to entry: A surface can be one that the user is in regular contact and be the potential for a hazardous
situation such as contain sharp points or edges; alternatively, the user can lose contact with the surface
unexpectedly due to lack of friction.
Note 2 to entry: A surface can be a point of contact that a user can fall onto and resulting in an injury. This can
also be a point of contact within the play, sport and recreation facility or environment.
3.39
activity leader
person assigned by a group or organization to lead an activity (3.1)
EXAMPLE Games leader, orienteering leader, canoe trip leader.
Note 1 to entry: Specific levels of training or competency in leadership and skills may be required by the group or
organization before an individual is permitted to lead an activity.
4 Benefit-risk assessment — Process overview
4.1 Assessment team
Benefit-risk assessments should be conducted by a team of at least three members with relevant
expertise in an activity, facility, or product. Teams should be kept to the minimum number of
participants necessary to include all relevant expertise.
Team membership should be maintained for at least the duration of the first review cycle; see 8.2 to
help ensure the continuity of team wisdom.
The person designated as the team leader should have training and experience according to the
requirements of Clause 9 and have experience facilitating effective committee work, including the
development of consensus.
The team leader should determine the types of expertise needed in the team.
Team members are typically drawn from one of the following three groups:
— product and facility designers;
— site managers;
— activity leaders.
4.2 Project scope
4.2.1 General
4.2.1.1 Overview
The benefit-risk assessment shall be a total package, consisting of three distinct processes:
a) definition of context;
b) identification of user (parallel process);
c) evaluation of the risk and benefit.
Figure 1 illustrates the flow of the procedures specified in this document.
4.2.1.2 Establishing the context
The establishment of the context shall be the first task performed when conducting a benefit-risk
analysis. Developing context involves communication between stakeholders.
The context is related to the requirement to assess a product, facility/location, or activity during its
conduct.
The purpose of establishing the context is to define which of the assessment approaches (see 4.2.1) is
most appropriate to the circumstances, enabling effective risk assessment and appropriate management
of the activity. There are two contexts that should be considered, the internal and the external. Both the
internal and the external contexts are important.
The overall context includes the goals of the organization and the nature of the facility or activity,
and the social acceptance of the risks related to the activity, e.g. the type of recreational or sporting
experience that the organization intends to provide, the nature of the activity itself and the inherent
benefits and risks created by that activity, any unique benefits or risks related to the geographic
location or other relevant factors.
The context of the benefit-risk management process should be established from an understanding of
the external and internal environment in which the organization operates, and the environment where
the activity takes place.
Understanding the context is important because:
— benefit assessment is directly connected to the type and geographic location of the activity, and the
social aspects, i.e. individual, family or team oriented, competitive or non-competitive, etc.;
— risk management takes place in the context of the objectives and activities of the organization;
— organizational factors can be a source of both benefits and risks;
— purpose and scope of the benefit-risk management process may be interrelated with the objectives
of the organization.
In establishing the context, benefit-risk assessors should determine whether participation in an
activity is mandatory or voluntary. Voluntary participation can take the form of being a member of a
sport association and being active in a competition, while participation is mandatory during a gym
class. A weighing of the risks and benefits of, for example, mandatory participation in a rugby activity
as part of an obligatory physical education class or as a competition from a sport association, results in
a different risk appetite.
4.2.1.3 Parallel processes
The benefit-risk assessment shall be a total package with two parallel processes: the benefits
assessment and the risk assessment, concluding with a final evaluation of the benefit-risk balance and
ongoing maintenance activities.
4.2.1.4 Identification of users
Following the establishment of the context, the next step is to determine the expected users of the
activity, product or service and any spectators. Consideration should be given to the following:
— age;
— physical size;
— skills;
— capacity for judgement;
— capacity for supervision.
Once the user is identified, the process moves to two parallel processes. The order in which they are
performed can be determined by the assessment team.
a) The identification and evaluation of the benefits from the activity begins with the identification
of the expected benefits. The context that can increase the benefit in relation to the same activity,
service or facility being in another location are identified. At this point a benefit analysis can be
performed, including identification of any precedents and comparisons.
b) The performance of a risk assessment takes into consideration the user and the reasonably
foreseeable misuse(s). The process continues with hazard identification and development of an
understanding of the potential severity of injury or a specified harm. At this point an estimation of
the risk can be performed, resulting in the overall evaluation of the risk. Any risk limitations set by
the context shall be considered during this process.
4.2.1.5 Evaluation of benefit and risk
Following the benefits and risk assessments, a further evaluation of the risk and benefit shall be
completed. This process results in a decision as to whether the risk is tolerable or whether the benefits
outweigh the risks, or both. At this stage, the external and internal contexts shall be taken into
consideration in determining whether an activity can move forward.
The decision related to the benefits outweighing the risk either results in the activity moving forward
or being re-evaluated for further risk reduction.
Where the decision results in a need for further risk reduction, the team has the option of:
a) returning to the hazard identification and determining if the risk(s) have been adequately reduced
for the project to proceed; or
b) returning to the beginning of the start of the entire process, re-evaluating both the benefits and the
risks with different starting parameters, such as the types of users or other parameters.
Where the activity moves forward, the decision shall be validated and documented.
4.2.1.6 Monitoring and periodic re-evaluation
Periodic monitoring and re-evaluation of the benefits and risks shall be conducted, which means
performing the entire process again.
Figure 1 — Benefit-risk assessment process
4.2.2 External and internal context
4.2.2.1 General
The context of the benefit-risk assessment provides an understanding of the background against which
the benefits and risks are considered. The context forms part of the scope of the benefit-risk assessment
in that it informs both the benefit assessment and the risk assessment regarding the legal limitations
placed upon the assessors, and the limits for risk tolerability, in addition to other considerations
described in this document. The limits on risk tolerability are described as risk criteria; see 5.3.2.
Cultural and legal aspects affecting the level of risk appetite shall be part of establishing the context.
The level of risk from unknown factors shall not be overestimated.
4.2.2.2 Consideration of contexts
At least two contexts should be considered when developing the scope of the benefit-risk assessment,
the external and the internal. The analyst shall examine both the internal and the external contexts
before selecting a benefit-risk assessment approach.
Examination of the exter
...