ISO 23217:2024
(Main)Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use. Use steps include any handling action performed after the patient has received the product; these can include but are not limited to: — transport – carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus); — storage – storage by the patient in their home, school, office or in temporary storage cases before or between uses; — preparation – steps necessary to place the product in a state where it is ready to be administered; — operation – steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication using the product; — maintenance – steps necessary to keep the product in good working order; — disposal – steps to ensure safe disposal of the product after use (e.g. placement of the product in a suitable receptacle). This document is applicable to injectable drug delivery systems for administration of medicinal products. Furthermore, this document can be useful for the development of other drug delivery devices or systems if they are intended for use by the paediatric population. Devices not in the scope of this document include catheters, for example those in the scope of ISO 10555 series, and infusion pump systems, e.g. IEC 60601-2-24 and aerosol delivery devices (ISO 20072).
Systèmes d'injection pour auto-administration par des patients pédiatriques — Exigences et lignes directrices relatives à la conception
General Information
Relations
Standards Content (Sample)
International
Standard
ISO 23217
First edition
Injection systems for self-
2024-02
administration by paediatric
patients — Requirements and
guidelines for design
Systèmes d'injection pour auto-administration par des patients
pédiatriques — Exigences et lignes directrices relatives à la
conception
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Considerations for design inputs . 5
4.1 General .5
4.2 Risk assessment and usability engineering .5
4.2.1 Risk assessment .5
4.2.2 Usability engineering .5
4.3 Considerations for the determination of requirements for the design of medical devices
specific to paediatric users . . .5
4.3.1 Considerations in relation to risk (risk-based approach to design) .5
4.3.2 Considerations in relation to human factors .5
4.3.3 Considerations for accompanying documentation . 12
5 Development of the design .12
6 Design verification and validation .13
6.1 General . 13
6.2 Design verification . 13
6.3 Design validation . 13
6.3.1 General . 13
6.3.2 Usability evaluations (also known as usability tests or user studies) . 13
6.3.3 Clinical evaluation.14
Annex A (informative) Additional considerations for the “paediatric population” .16
Bibliography .37
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
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complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
An increasing number of therapies for paediatric use rely upon a drug delivery system for administration.
However, many existing drug delivery systems in widespread use incorporate design features that might not
conform with current thinking on human factors/usability engineering principles for use by the paediatric
population or include some significant differences from those applicable to the average adult user population
and other demographic groups. In some cases, these design features can result in incorrect use of the drug
delivery system and unacceptable risks.
Therefore, guidelines on the design input to the development of drug delivery systems specifically intended
for administration of medicinal products by paediatric users are relevant. Especially, guidelines are
relevant for development of those devices where the paediatric user is performing some or all use steps.
The guidelines in this document are dedicated to those products. Guidelines in relation to the development
of products intended for administration of medicinal products by caregivers only are not covered by this
document as those devices are developed for the average adult population.
Due to the variation of design of drug delivery systems, this document does not specify requirements for
developing, assessing and evaluating drug delivery systems.
Manufacturers should follow a risk-based approach during the design and development of drug delivery
systems serving the paediatric population.
Figure 1 summarizes the applicability of this document.
Figure 1 — Roadmap for the use of this document
Guidance on transition periods for implementing the content of this document is given in ISO/TR 19244.
v
International Standard ISO 23217:2024(en)
Injection systems for self-administration by paediatric
patients — Requirements and guidelines for design
1 Scope
This document provides requirements and guidelines on the development of drug delivery systems intended
for self-administration of medicinal products by the specific demographic group of paediatric patients who
are performing some or all use steps required for their intended use.
Use steps include any handling action performed after the patient has received the product; these can
include but are not limited to:
— transport – carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus);
— storage – storage by the patient in their home, school, office or in temporary storage cases before or
between uses;
— preparation – steps necessary to place the product in a state where it is ready to be administered;
— operation – steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication
using the product;
— maintenance – steps necessary to keep the product in good working order;
— disposal – steps to ensure safe disposal of the product after use (e.g. placement of the product in a suitable
receptacle).
This document is applicable to injectable drug delivery systems for administration of medicinal products.
Furthermore, this document can be useful for the development of other drug delivery devices or systems
if they are intended for use by the paediatric population. Devices not in the scope of this document include
catheters, for example those in the scope of ISO 10555 series, and infusion pump systems, e.g. IEC 60601-2-24
and aerosol delivery devices (ISO 20072).
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 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019, Medical devices — Application of risk management to medical devices
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
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
accompanying documentation
materials accompanying a medical device and containing information for the user (3.15) or those accountable
for the installation, use and maintenance of the medical device, particularly regarding safe use
Note 1 to entry: The accompanying documentation can consist of the instructions for use (3.8), technical description,
installation manual, quick reference guide, etc.
Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but can involve
auditory, visual, or tactile materials and multiple media types.
Note 3 to entry: Medical devices that can be used safely without instructions for use are exempted from having
instructions for use by some authorities with jurisdiction.
[SOURCE: ISO 14971:2019, 3.1, modified — "decommissioning and disposal" have been deleted from the
definition, and Note 3 to entry has been added.]
3.2
caregiver
non-professionals (e.g. family members, parents, guardians or friends) who provide care to the patient (3.11)
3.3
drug delivery system
medical device or system whose primary purpose is the administration of a medicinal product such as drugs
and biologics
Note 1 to entry: This term applies to combination of components and subassemblies of the system that are intended to
be integrated with the medicinal product with the purpose of providing a method of administration of the medicinal
product.
[SOURCE: ISO 20069:2019, 3.1.2]
3.4
harm
injury or damage to the health of people, or damage to property or the environment
3.5
hazard
potential source of harm (3.4)
[SOURCE: ISO/IEC Guide 63:2019, 3.2]
3.6
health care provider
healthcare professional with proficient skills and experience with the use of a device so that they can aid or
train patients and caregivers (3.2) to use and maintain the device
3.7
usability engineering
human factors engineering
UE/HFE
application of knowledge about human behaviour, abilities, limitations, and other characteristics to the
design of medical devices (including software), systems and tasks to achieve adequate usability (3.13)
Note 1 to entry: Achieving adequate usability can result in acceptable risk (3.19) related to use.
[SOURCE: IEC 62366-1:2015, 3.17]
3.8
instructions for use
IFU
directions provided by the manufacturer for the correct handling and operation of the drug delivery system
(3.3)
[SOURCE: ISO 11608-1:2022, 3.10, modified — “needle-based injection system” replaced with “drug delivery
system”.]
3.9
intended use
use specification
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with,
user profile (3.17), use environment, and operating principle are typical elements of the intended use.
[SOURCE: ISO/IEC Guide 63:2019, 3.4, modified — the preferred terms "use specification" and "intended
purpose" have been added.]
3.10
paediatric
relating to children and/or adolescents
Note 1 to entry: The definition of paediatric varies by region and organization. See Annex A for different organizations’
classifications of “child” and “adolescent”.
3.11
patient
person undergoing a medical, surgical, or dental procedure
3.12
self-administration
process by which the patient (3.11) enters medication into their own body
3.13
usability
characteristic of the user interface (3.16) that facilitates use and thereby establishes effectiveness, efficiency
and user satisfaction in the intended use environment
Note 1 to entry: All aspects of usability, including effectiveness, efficiency, and user satisfaction, can either increase or
decrease safety.
[SOURCE: IEC 62366-1:2015, 3.16]
3.14
use error
user (3.15) action or lack of user action while using the medical device that leads to a different result than
intended by the manufacturer or expected by the user
Note 1 to entry: Use error includes the inability of the user to complete a task.
Note 2 to entry: Use errors can result from a mismatch between the characteristics of the user, user interface (3.16),
task, or use environment.
Note 3 to entry: Users can be aware or unaware that a use error has occurred.
Note 4 to entry: An unexpected physiological response of the patient (3.11) is not by itself considered use error.
Note 5 to entry: A malfunction of a medical device that causes an unexpected result is not considered a use error.
[SOURCE: IEC 62366-1:2015, 3.21, modified — Note 6 to entry has been deleted.]
3.15
user
person interacting with (i.e. operating or handling) the medical device
Note 1 to entry: There can be more than one user of a medical device.
Note 2 to entry: Common users include clinicians, health care providers (3.6), patients (3.11), caregivers (3.2).
[SOURCE: IEC 62366-1:2015, 3.24, modified — Note 2 to entry has been changed.]
3.16
user interface
means by which the user (3.15) and the medical device interact
Note 1 to entry: User interface includes all the elements of the medical device with which the user interacts including
accompanying documentation (3.1), packaging, and the physical aspects of the medical device as well as visual,
auditory, tactile displays and is not limited to a software interface.
Note 2 to entry: A system of medical devices can be treated as a single user interface.
[SOURCE: IEC 62366-1:2015, 3.26, modified — Note 1 to entry has been deleted.]
3.17
user profile
summary of the mental, physical and demographic traits of a user (3.15) group, as well as characteristics,
such as knowledge, skills and abilities, which can have a bearing on design decisions
[SOURCE: IEC 62366-1:2015/Amd 1:2020, 3.29]
3.18
residual risk
risk (3.19) remaining after risk control (3.21) measures have been implemented
[SOURCE: ISO/IEC Guide 63:2019, 3.9]
3.19
risk
combination of the probability of occurrence of harm (3.4) and the severity of that harm
[SOURCE: ISO/IEC Guide 63:2019, 3.10, modified — Note 1 to entry deleted.]
3.20
risk analysis
systematic use of available information to identify hazards (3.5) and to estimate the risk (3.19)
[SOURCE: ISO/IEC Guide 63:2019, 3.11]
3.21
risk control
process in which decisions are made and measures implemented by which risks (3.19) are reduced to, or
maintained within, specified levels
[SOURCE: ISO/IEC Guide 63:2019, 3.12]
3.22
risk evaluation
process of comparing the estimated risk (3.19) against given risk criteria to determine the acceptability of
the risk
[SOURCE: ISO/IEC Guide 63:2019, 3.14]
4 Considerations for design inputs
4.1 General
The specific requirements that shall be fulfilled for a specific demographic population can partly be
developed by applying the risk approach (see 4.2.1) and usability engineering (see 4.2.2) specified in
applicable standards.
4.2 Risk assessment and usability engineering
4.2.1 Risk assessment
The manufacturer shall perform risk analysis, risk evaluation, risk control and an evaluation of residual risk
acceptability in accordance with ISO 14971.
4.2.2 Usability engineering
A usability engineering program in accordance with IEC 62366-1 shall be applied. It shall include addressing
use risks and tests and/or assessments throughout the development and as part of the design verification
and design validation.
4.3 Considerations for the determination of requirements for the design of medical devices
specific to paediatric users
4.3.1 Considerations in relation to risk (risk-based approach to design)
The risk assessment in accordance with ISO 14971 shall take into account the characteristics of the paediatric
users including use risks in accordance with IEC 62366-1. See Table A.4 for examples of potential use errors.
4.3.2 Considerations in relation to human factors
4.3.2.1 General
During the design and development of a drug delivery system intended for self-administration by paediatric
users, the intended uses, intended user profiles, and use environments shall be identified and clearly defined.
Based on the human factors’ considerations, the requirements for the medical device shall be documented.
NOTE 4.3.2 highlights aspects of the HFE/UE process defined and documented in IEC 62366-1 that require special
attention when developing drug delivery systems for paediatric use.
4.3.2.2 Characterization of the intended use
4.3.2.2.1 Intended user profiles
The socio-economic environment, cognitive and physical development, age and aptitude of the intended
user shall be defined. Within the population of paediatric users, variation can be expected in terms of size,
strength, stamina, skeletal maturity, coordination (e.g. gross and fine motor skills), visual, tactile, auditory
and perceptual capabilities, emotional maturity, motivation, decision-making abilities and the impact of
their medical condition on their ability to use the drug delivery system safely and effectively. Furthermore,
if it is anticipated that a paediatric user needs the support of a healthcare provider or caregiver to use the
drug delivery system, the limitations and capabilities of adult users shall also be defined.
4.3.2.2.2 Intended use environment
The environment of intended use shall be characterized. Paediatric users tend to lead active lifestyles and
so some medical products are used outside of the home (e.g. at school or on sports fields). During these use
scenarios they can be exposed to environmental factors (e.g. bright sunlight or excess temperatures) or used
in a non-private setting.
4.3.2.3 Use-related risk
Manufacturers shall identify hazard-related use scenarios in accordance with IEC 62366-1, including
potential use errors that can occur, identify known or foreseeable hazards and hazardous situations, and
ensure that they are adequately controlled. When identifying and evaluating use-related risk, the content
of the intended use shall be defined, and for drug delivery systems that are similar to the one under
development with regard to use, the user interface or user interactions shall be analysed. The source of
identification of potential use errors and risks can include human factors evaluations, literature research,
and market experience.
4.3.2.4 User interface
4.3.2.4.1 General
When developing user interface requirements, the following aspects shall be evaluated.
It shall be evaluated how risks can be suitably controlled through the design of the drug delivery system
including its associated materials. As covered in ISO 14971:2019, 6.2 the manufacturer shall use one or more
of the following risk control options in the priority order listed:
a) inherent safety by design;
b) protective measures in the medical device itself or in the manufacturing process;
c) information for safety.
4.3.2.4.2 Design attributes
The characteristics of the paediatric user shall inform the design and development of a drug delivery system.
General drug delivery system design considerations are given in Table 1.
4.3.2.4.3 Training
While it is preferable to control risks through drug delivery system design, including associated materials,
in some circumstances, mitigation by design alone can be insufficient for a paediatric population. In these
situations, it can be appropriate to employ a training program. If training is a necessary component to
mitigate risk of the drug delivery system, the manufacturer shall validate the effectiveness of the training
program and justify how it is representative of the training that will be provided in commercial use of the
drug delivery system.
The manner in which the training will be consistently implemented in the field shall be defined, however
the risk of users not being trained shall also be assessed. For example, lay caregivers can learn how to use
the system by observing a patient or another lay caregiver, and health care providers might not be directly
trained.
4.3.2.4.4 Experience and knowledge of similar or other drug delivery systems
Paediatric users vary in their experience of managing their medication and of using similar drug delivery
systems. Similarly, the knowledge and experience of their supporting health care provider or caregiver
also vary. Therefore, the impact that both positive and negative knowledge transfer can have on safe and
effective use of the drug delivery system shall be evaluated.
4.3.2.4.5 Dose regime
The medical condition and thus dosing regimen can influence the drug delivery system design and shall be
evaluated in relation to managing complexity.
For example, whether:
— the medication is a fixed dose or requires the user to set the required dose;
— training information is retained (e.g. if the medication is administered infrequently);
— the medication shall be given very frequently and/or at a fixed time of day, in a home environment or
elsewhere.
4.3.2.4.6 Transportation, storage, preparation, operation, maintenance and disposal by the user
Requirements for transportation, storage, preparation, operation, maintenance and disposal of the
drug delivery system shall be defined. E.g. if the medication is stored under refrigerated conditions, the
circumstances under which temperature excursions can occur shall be identified when describing potential
use scenarios.
Table 1 — General drug delivery system design considerations
Paediatric design
User interface interaction
Disease conditions impact
characteristics
Considerations Illustrative examples
Perception — Sight (field of Certain disease conditions/disabilities can affect: — Design (including instructions for use — Children who have visual difficulties and
(sensory) view, colour, materials) shall be based on children’s language limitations can benefit from
— visual capabilities (e.g. low vision, myopia,
contrast, acuity). senses, limitations and preferences. warnings they can hear. Avoid complex
etc.) and cause defective vision (e.g. colour
wording and ensure appropriate speed.
blindness, etc.);
— Hearing (sound — Design shall use appropriate senses
detection, speech for informing/feedback. — Identify which sense(s) can be used for
— hearing capabilities and cause deafness;
discrimination, informing when a dose is fully administered,
localization). — Design shall use simple and age or understand if speech-based warnings
— touch disorders or cause other impairments
[35]
appropriate language.
for potentially hazardous situations are
that can affect the ability to use touch (e.g.
— Touch (including needed to alert children who do not read
affecting tactile pressure).
proprioception). — Design shall provide age appropriate
easily.
affordance.
— Avoid complexity or too distractive systems.
NOTE Design affordance is an aspect of a
device which directs how it is used.
— Children who have visual difficulties or
— Design shall consider familiarity with touch disorders can benefit from design of
other model(s) of device(s) and build appropriate protective measures for needle,
design on child’s previous knowledge/ etc.
experiences.
— Adjust font size(s) in screen(s) and
instructions for use for legibility. When using
colour to convey information to children
with colour deficiencies, for example, locate
important information in the same place
[35]
each time it is presented .
Table 1 (continued)
Paediatric design
User interface interaction
Disease conditions impact
characteristics
Considerations Illustrative examples
Cognitive — Attention — Certain disease conditions/disabilities — Design shall consider that children — Present children with short, succinct tasks
(processing) (concentration). that can cause hyperactivity, impulsive can have attention span limitations rather than long ones or make warnings
behaviour, attention spans (e.g. Attention when using a device. “stand out” in order to capture children’s
— Recognition
Deficit Hyperactivity Disorder) or any attention.
(familiarity with cognitive development problem. — Design shall consider children’s
technology, health familiarity with other model(s) of — Guide the child’s steps to use the product
literacy, training). — Complexity of treatment, dose regimen, device(s) and/or their previous such as providing adequate dose completion
frequency of use, use environment (e.g. does knowledge/experiences that can notification.
— Language and
the paediatric patient have to take different influence their cognitive abilities
communication doses of a solution at different times during when using the device. — Avoid any abstract pictogram or symbol
(literacy, verbal, which can be misunderstood by children.
the day?).
nonverbal). — Design shall avoid labelling Ensure that they are noticeable and
characteristics that can lead children comprehended by the children; e.g. the skull
— Problem solving.
to believe that the product is safer and crossbones pictogram can be interpreted
[35]
than it really is. as “pirate food” instead of “poison” .
— Memory
(working, long — Design shall consider that young — Children can be mistakenly attracted to
term). children might not be able to dangerous products due to characteristics
understand the ramifications of an of the products packaging including colour,
action taken when using a product the container’s shape and the presence of
[35]
(e.g. a warning) or can just explore symbols or other characteristics .
a range of potential uses for an
[35] [41][42]
— For older children or adolescents, warnings
object .
that include explicit language can be more
— Design shall consider that information effective and warnings can be especially
or warnings can produce unintended valuable when combined with verbal
[35][41][42]
effects if they are misunderstood. warnings and instructions .
— Design shall use unambiguous and — What is intuitive for an 8-year-old might
adapted language. not be intuitive for a 6-year-old or even
for another 8-year-old with a different
[35]
— Design shall consider inter and intra background or maturity level .
age group differences: children can
change rapidly.
Table 1 (continued)
Paediatric design
User interface interaction
Disease conditions impact
characteristics
Considerations Illustrative examples
Emotional — Attitude: positive, — Patient education and training (e.g. asthma — Design shall consider that the socio- — How do parents/legal guardian care for
and psy- neutral, or care requires a partnership between the child, economic and cultural environment the paediatrics? Are they involved in the
chological negative feeling their parents and the health care professional. can be favourable or unfavourable to treatment? Does their environment distract
(Attitude) toward the Patients need to know about the causes of their the use of the device. them and how does that affect the use of the
system. disease, causes of exacerbations and, perhaps device?
most importantly, how to use the prescribed — Design shall consider children
[33]
— Motivation: medication and device reliably) . attitude/preferences towards the — The treatment compliance is known to be
low, moderate treatment and his disease. an issue for some children with chronic
or high due to — Severity of the disease conditions (e.g. does disorders, particularly those that do not
interest, fear the child see a direct impact from taking the — Design shall consider children’s result in immediate discomfort when
familiarity with other model of
(injection, pain, medicine? How tolerable it is for the child?). scheduled doses are missed or delayed.
etc.), adherence or device(s) and/or their previous
compliance to the — Chronic vs. periodic disease; chronic knowledge/experiences that can — Engage the child by opting for an appropriate,
system. diseases (e.g. asthma, diabetes, etc.) or influence their attitude towards the appealing, personalized design.
periodic/intermittent diseases. This can proposed system.
— Children can fear needles or pain, therefore
— Patience: patience influence the ability to comply with a therapy.
or impatience — The drug delivery system shall be consider using a system that hides the
— Complexity of dose regimen, frequency designed in a way that children can needle, needle shielding, etc.
expected in
accomplishing of use, use environment [e.g. does the child use them safely and fearlessly.
goal. have to take the medicine at lunch time (e.g. at
school)?].
— Expectations:
kindness and
reasonableness.
— Stress level:
high, some, or no
stress generally
resulting from
task performance.
— Socio-economic
and cultural
influence (family
context, country,
community, etc.).
Table 1 (continued)
Paediatric design
User interface interaction
Disease conditions impact
characteristics
Considerations Illustrative examples
Physical — Anthropometrics — Certain disease conditions/disabilities can — Design shall consider children’s body — Children’s injection sites and skin thickness
(action) (body size, affect children’s hand skills which affects anthropometrics to ensure safe and input help to ensure the dose can be
hand size, skin their engagement in manipulative activities effective delivery. administered effectively and safely; also
thickness, etc.). (e.g. arthritis, musculoskeletal disorders). consider the injection depth, the adequate
— Design shall consider disabilities needle length and whether there is a specific
— Strength (grip, — Severity of the disease conditions (e.g. or pre-existing musculoskeletal injection angle to apply.
push, pull, etc.). does the disease impact hand strength? How disorders, age, gender, stature, and
does that impact the daily life? Is it physically physical activity levels. Consider — Are there required physical capabilities
— Flexibility
tolerable?). what is “physically tolerable” for the that child has to have to maintain a precise
[35]
(achievable and paediatric patient when designing a posture while injecting?
comfortable — Chronic vs. periodic disease; chronic
drug delivery system.
postures). diseases (e.g. asthma, diabetes, etc.) or — Is the child physically able to manipulate the
periodic/intermittent diseases. This can — Design shall consider children’s system and to which extent is the child able
— Dexterity
influence physical capabilities. familiarity with other model of to grip the drug delivery system?
(acceptable forms device(s) and/or their previous
and operations). — Dosing regimen, formulation and accuracy — How much strength does the child need
knowledge/experiences that can
(e.g. does the child have a fixed dose or variable influence their actions/physical to remove a needle cap? How is the child
— Reach (acceptable dose? The dose regimen/volume is often based expected to open the packaging and use the
abilities when using the device.
heights and
on weight and development). drug delivery system?
offsets). ― Design shall consider cultural
differences and differences within
and among age groups.
Based on the attribute considerations noted in Table 1, the requirements for the medical device specific for
the population shall be documented as described in ISO 13485.
4.3.3 Considerations for accompanying documentation
Drug delivery system markings and instructions for use (IFU) text and illustrations shall be understandable
by the paediatric user. It can be necessary to include additional documentation intended for the caregiver, e.g.
a medication guide, to supplement the IFU. A lowest common denominator of literacy level shall be assessed
and used. It should be recognized that there can be ‘subpopulations’ within the population (see Annex A)
and that, based on the paediatric user’s physical development, self-administration, no matter how simple the
instructions are, may not be appropriate. Consider use of additional electronic labelling, e.g. animation with
demographically-relevant simulation.
Different complexities for IFU and markings shall be age appropriate and developmentally appropriate, e.g.
instructions, explanations, drug delivery system accessories that use age appropriate language and visual
aids/graphics. This includes:
— marking on the drug delivery system (e.g. accuracy of graduations) in accordance with relevant product
standards;
— marking on the user packaging and/or unit packaging;
— legibility;
— IFU;
— information provided in electronic format that matches the validated labelling.
5 Development of the design
The manufacturer shall plan and control the design and development of the device based on:
— the requirements specified in ISO 13485;
— continuation of a risk-based approach in accordance with ISO 14971, which shall be performed in relation
to risks that can arise given the application specifically to the intended user population;
— continuation of usability engineering in accordance with IEC 62366-1.
The manufacturer shall establish appropriate design and engineering specifications (e.g. assembly and
component drawings, test and inspection criteria), such that the device exhibits the necessary form, fit and
function design attributes to suit the intended patient demographic population. Examples of such attributes
are provided in Table A.2. The chosen specification shall be justified and documented in the technical file.
Additional engineering specifications can be required based on the device design.
Design and development and risk approach documentation shall be maintained and updated as the design
and development progresses.
Preference shall be given to mitigating risks by design or process rather than by providing training alone,
marking, warnings, labelling and IFU, since the risk mitigation by these tools can be less effective.
It shall be recognized that there can be ‘populations’ or ‘subpopulations’ where the risks associated with
self-administration are not acceptable no matter how simple the instructions and design are.
NOTE ISO 13485 specifies requirements for design and development planning and execution. The risk approach
can be derived from ISO 14971, which specifies requirements for risk management in relation to medical devices.
6 Design verification and validation
6.1 General
The manufacturer shall plan and execute the design verification and validation of the product based on:
— the requirements specified in ISO 13485;
— completion of a risk-based approach including risk analysis, risk evaluation, risk control, evaluation of
residual risk acceptability in accordance with ISO 14971:2019, Clauses 4 to 8, which shall be performed
in relation to risks that can arise given the application specifically to the intended users;
— completion of usability engineering in accordance with IEC 62366-1.
6.2 Design verification
The final design shall be fully verified including those specifications developed for the intended users.
NOTE If considering a specific demographic as part of a change to an existing design, then verification data for the
existing design can be supplemented with justifications, risk assessments and/or by new verification testing for the
new attributes/specifications alone.
6.3 Design validation
6.3.1 General
The final design of the drug delivery system shall be validated to ensure that the product can meet the
requirements for the specified application or intended use.
If considering a change to an existing design to enable use by intended paediatric users, then validation data
for the existing design shall be supplemented with justifications, risk assessments, and/or by new validation
testing.
The drug delivery system labelling shall be validated for safe and effective use by simulated use testing that
involves users of the intended population.
NOTE Validation can include data from other sources than usability and clinical studies such as clinical
evaluations, market experience, literature, etc.
6.3.2 Usability evaluations (also known as usability tests or user studies)
Formative and/or summative evaluations shall be conducted as part of a drug delivery system development
in accordance with IEC 62366-1 to demonstrate the safe and effective use of the drug delivery system and
associated materials. When conducting such evaluations with paediatric users, the following aspects shall
be assessed:
a) Informed consent
Paediatric patients are largely unable to legally provide informed consent and are dependent on their
parent/legal guardian to consent to participation in a usability evaluation.
b) User groups
Users can vary considerably in terms of aspects that can influence the use of a drug delivery system. It
can therefore be necessary to identify separate user groups differentiated by characteristics as noted
in Table 1; e.g. for paediatric users, consider use of the drug delivery system by the user as well as by lay
caregivers (e.g. the user’s parent/legal guardian).
c) Support involvement
Depending on the nature of the usability evaluation and the user profile (e.g. age, disease conditions),
it can be necessary to involve both paediatric users and lay caregivers (e.g. the user’s parent/legal
guardian) in the evaluation session. It is acceptable for paediatric users to be accompanied and/
or assisted by e.g. their parent/legal guardian if this is representative of the drug delivery system’s
intended use environment and end users. Observing the representative users operating the drug
delivery system realistically will help understand the safety and effectiveness of use. The evaluation
shall be designed to ensure a simulation as realistic as possible, and to enable feedback from both the
lay caregiver and the paediatric user.
d) Recruitment
The recruitment of paediatric users can be conducted through parents or legal guardians rather than
directly, depending on the age of the paediatric user and local laws/regulations. The recruitment of
paediatric users can take longer than recruiting adults, users can be less likely to attend their scheduled
interview (e.g. due to a change in circumstances) and evaluation sessions can be conducted from late
afternoon (i.e. after school and school activities).
e) Simulated use environment
The environment simulated during the usability evaluation shall be representative of the intended
use environment and be accommodating for the specific population being evaluated. The parent/legal
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