ISO/DTR 25555

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ISO /DTR 25555:2023(E)
ISO /TC 314
Secretariat: BSI
2023-05-2507-26
Ageing societies—Accessibility and usability considerations for home-based healthcare
products, related services and environments


DTR stage

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ISO/TR 25555:2023(E)
Contents
Foreword . ⅳ
Introduction. ⅴ
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations for increasing accessibility and usability . 3
4.1 Safety and security . 3
4.2 Cleanness, disinfection and sterilization . 3
4.3 Independence and autonomy of care recipients . 3
4.4 Accessibility in general . 3
5 Considerations on home healthcare products for increasing accessibility and
usability . 4
5.1 Operation . 4
5.1.1 General considerations . 4
5.1.2 Specific considerations . 5
5.2 Information and marking . 7
5.2.1 General considerations . 7
5.2.2 Specific considerations . 8
6 Considerations on services related to use of home healthcare products for
increasing accessibility and usability . 12
6.1 General considerations . 12
6.2 Specific considerations . 12
7 Considerations on environments for use of home healthcare products for increasing
accessibility and usability . 13
7.1 General considerations . 13
7.2 Specific considerations . 13
7.2.1 Lighting environment . 13
7.2.2 Sound environment . 14
7.2.3 Thermal and air quality environment . 15
7.2.4 Others . 15
Annex A (informative) Major home healthcare products and users . 17
A.1 Major home healthcare products, their users, and places of use . 17
A.2 Major care recipients of home healthcare. 18
Annex B (informative) Examples of home healthcare products . 20
B.1 General . 20
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B.2 Examples . 20
Bibliography . 25

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ISO/TR 25555:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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Field Code Changed
This document was prepared by Technical Committee [or Project Committee] ISO/TC 314, Ageing
societies.
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.
Field Code Changed
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Introduction
With the increasing need for community-based integrated care to meet rapidly ageing societies, medical
activities and healthcare services carried out at a home or a domestic environment have become
commonplace. These activities and services can be referred to as home healthcare and the, whose aim of
which is to provide quality of life that includes independence, autonomy, safety and security for older
persons.
Various types of products, medical or non-medical, and their related services and environments are being
used in home healthcare. Many older persons and non-professional caregivers are now users of these
products. The variety of products and users can create challenges that are unseen in professional
healthcare facilities. The biggest challenge of them all is that it is difficult to find relevant information
from the existing design fields to accommodate, apply and use home healthcare products.
There is much information on accessibility and usability in existing international standards and
guidelines involving major products’ fields including medical products. However, these documents do not
fully cover the home healthcare products and related services and environments. The problem, in
particular, is that it is difficult and time consuming to locate relevant information from those design fields
to accommodate and to apply home healthcare products.
This document summarizes and catalogues this information into one document for practical use. The
information was obtained from existing International Standards, regional or global guidelines for
products and medical equipment, and also is based on empirical feedback from home healthcare product
users.
This document also provides caregivers and care recipients and those who develop and distribute home
healthcare products with information useful for:
— solving problems regarding the use of these products by caregivers and care recipients who might
lack sufficient expertise and skills in handling medical products and activities, and
— solving problems regarding the use of home healthcare products outside of medical facilities.

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ISO/DTR 25555:2023(E)

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TECHNICAL REPORT ISO/DTR 25555:2023(E)

Ageing societies—Accessibility and usability considerations for
home healthcare products, related services and environments
1 Scope
This document provides a collection of design considerations from existing international standards as
well as best practices and observations obtained from the home healthcare field. This document is
intended to be used as a reference for designing accessibility and usability of home healthcare products
and associated services, and environments designed for non-professional users.
This document does not provide information on the use of home healthcare products by healthcare
professionals regardless of the place and facility of use.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
Field Code Changed
— IEC Electropedia: available at https://www.electropedia.orghttps://www.electropedia.org/
3.1
accessibility
extent to which products, systems, services, environments and facilities can be used by people from a
population with the widest range of user needs, characteristics and capabilities to achieve identified goals
in identified contexts of use
Note 1 to entry: Context of use includes direct use or use supported by assistive technologies.
[SOURCE: ISO 9241-112, definition:2017, 3.15]
3.2
caregiver
person who provides physical and mental healthcare
3.3
care recipient
person who receives physical and mental healthcare
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ISO/DTR 25555:2023(E)
3.4
home healthcare
healthcare provided in a dwelling place in which a care recipient lives or other places where care
recipients are present, excluding professional healthcare facility environments where operators with
medical training are continually available when care recipients are present
Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres,
dental office, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms, multiple
treatment facilities and emergency medical services.
Note 2 to entry: For the purpose of this document, nursing homes are considered dwelling places for home
healthcare.
Note 3 to entry: Other places where a care recipient is present include the outdoor environments while working
and in vehicles.
[SOURCE: IEC 60601--1-11:2015+AMD1:2020, 3.1, modified － ”— The term “home healthcare
environment” was replaced with “home healthcare”, “healthcare provided in a” was added at the
beginning, “patient” was replaced with “care recipients”, EXAMPLE is deleted, Note to entry 2 “collateral
standard” was replaced with “document” and “home healthcare environments” was replaced with
“dwelling places for home healthcare”.]
3.5
home healthcare product
product used in home healthcare (3.4), related to services and environments
Note 1 to entry: Major home healthcare products are listed and classified in Annex A together with their users and
places of use.
3.6
healthcare professional

person who has a professional qualification for providing healthcare
3.7
3.6
medical product
product and its accessory intended to use for medical activity
3.7
non-medical product
product and its accessory not intended to use for medical activity
3.8
selfcare
care which is provided by a care recipient (3.3) oneself
3.9
usability
extent to which a product can be used by specified users (3.109) to achieve specified goals with
effectiveness, efficiency and satisfaction in a specified context of use
[SOURCE: ISO 9241-11:1998, 3.1]2018, 3.1.1, 3.1, modified —Notes to entry deleted.]
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ISO/DTR 25555:2023(E)
3.109
user
person who uses the home healthcare products
Note 1 to entry: User includes healthcare professional (3.56), caregiver (3.2) and care recipient (3.3).
4 General considerations for increasing accessibility and usability
4.1 Safety and security
Safety and security of home healthcare products, related services and environments are of primary
importance in their use by the widest range of caregivers and care recipients, some of whom lack expert
knowledge and skills in handling medical products, equipment and activities. Safety and security are also
important for the widest range of use environments of home healthcare products where professional
healthcare facilities are not available.
4.2 Cleanness, disinfection and sterilization
Cleanness, disinfection and sterilization of home healthcare products, related services and environments
have been identified as essential to avoid any risk of disease for the widest range of users and context of
use of them.
The following practices have proven particularly effective in handling home healthcare products.
a) Avoidance of multiple uses of the products among different care recipients and caregivers is effective
[25]
to reduce the risk of infection, in particular for some care recipients who are apt to be infected .

b) Zoning or partitioning of a space or a room for environments for use of home healthcare products
[25]
and for related services is effective to reduce the risks of infection .

NOTE There are some care recipients who are apt to be infected with diseases.
4.3 Independence and autonomy of care recipients
To support the independence and autonomy of care recipients is deemed as important as providing
means of self-use, on-demand-use, and consent-use of home healthcare products by care recipients.
4.4 Accessibility in general
[1 ]
Accessibility guidance in ISO/IEC Guide 71:2014 [, ], when applied, increases accessibility of home
healthcare products, related services and environments. Among the guidance, the following have proven
particularly effective in using home healthcare products in general.
a) Suitability for the widest range of users and diverse contexts of use
Designing home healthcare products, related services and environments usable by diverse users as
caregivers and care recipients and in diverse environments, except in professional healthcare facilities
[1]
increases accessibility. See ISO/IEC Guide 71:2014, 6.2.1 .
b) Providing multiple means of information presentation and user interaction
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ISO/DTR 25555:2023(E)
Home healthcare products, related services and environments that have multiple means of information
presentation and multiple means of operation for use increase accessibility. See ISO/IEC Guide 71:2014,
[1]
8.2.1 .
NOTE 1 Multiple means of information presentation include different sensory information such as seeing, hearing,
and touch, and also different modes of information within one sense such as shape and colour in vision.
NOTE 2 Multiple means of operation for use include different types and modes of actions such as with one hand
and both hands, in standing and sitting positions, or by voice and body movement.
c) Ensuring compatibility
Home healthcare products, related services and environments that have compatible use with assistive
products and technology used by care recipients increase accessibility. See ISO/IEC Guide 71:2014, 8.2.7
[1 ]
[. ]. Home healthcare products increase their accessibility for wheelchair users, if they are designed
portable, mobile and compact in size for outdoor use in wheelchair.
Compatibility also concerns software and data transfer of ICT products and health monitoring or
measuring systems. ICT products that can run under different operating systems or measured data that
can be transferred and read by different systems increase accessibility and usability.
NOTE 3 ISO/IEEE 11073-10418 specifies a normative definition of communication between personal telehealth
International Normalized Ratio (INR) devices and managers (e.g. cell phones, personal computers, personal health
appliances) in a manner that enables plug-and-play interoperability.
d) Harmonization with safety and security
Harmonization of accessibility with safety and security is important. Safety as safety and security
protocols that have a competing situation with accessibility cause accessibility problems.
[24]
EXAMPLE A child resistance operation for an ignition device. As for child safety, see ISO/IEC Guide 50 .
5 Considerations on home healthcare products for increasing accessibility and
usability
5.1 Operation
5.1.1 General considerations
Simple and easy operation of home healthcare products increases accessibility and usability for
caregivers and the recipients, some of whom lack expertized knowledge and skills in handling medical
products, equipment and activities.
The following are general considerations for increasing accessibility and usability regarding operation of
home healthcare products in general.
a) Providing alternative means of operation at least for major operations for home healthcare products
(see 4.4b).
EXAMPLE 1 The character input system using eye movement or head movement in addition to a keyboard or
a ten-key for an IT device. See B.2.1a) and b).
b) Avoidance of simultaneous two or more different actions except for special case to keep safety. See
[1]
ISO/IEC Guide 71:2014, 7.4.3 .
c) Facilitation of intuitive understanding of operating procedures from the design of home healthcare
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ISO/DTR 25555:2023(E)
[2]
products or the controls, i.e.,. shape or marking. See ISO/TR 22411:2021, 8.17.4 .
EXAMPLE 2 The action for peeling off the cover seal of an adhesive plaster (see B.2.2).
d) Arrangement of sequential operations for home healthcare products in a logical and easy-to-
[2]
understand way both spatially and temporally. See ISO/TR 22411:2021, 8.3.3 .
e) Placement of controls in an adjacent area which are functionally related to each other.
f) An illustration that indicates the identical physical layout of controls.
g) Automatic processing of a series of complex and sequential operations.
EXAMPLE 3 An automatic blood pressure meter (see B.2.3).
h) Informing the effects or changes in products caused by operations in multiple means of information
presentation, such as lights and sounds, during or immediately after the operation and in accordance
with the physical changes by the operation (i.e. direction or amount). See ISO/TR 22411:2021, 8.17.2
[2]
.
EXAMPLE 4 Oxygen supplying units (see B.2.5).
i) Designing home healthcare products so that miss-operation can never happen during use.
j) Designing home healthcare products to minimize or to remove the effects of miss-operation when it
[3]
happens during use. See ISO/IEC Guide 71:20012014, 8.21 .
5.1.2 Specific considerations
The following are product- or design-specific considerations for increasing accessibility and usability
regarding operation of home healthcare products.
a) Designing home healthcare products with a compact shape and size that is easy to operate and with
a light mass that is easy to carry.
NOTE 1 Home healthcare products are often used in rooms that are not spacious making operation and
installation of the products difficult.
NOTE 2 A research project in Japan reported that a comfortable mass of an object is less than 4 kg for older
[4]
males and females when a person lifts with two hands .
EXAMPLE 1 An air-pumping device (bag valve mask) easy to operate by hands.
b) Avoidance of an excessive burden of physical strength to the users in their operation of home
[2]
healthcare products. See ISO/TR 22411:2021, 8.12.3 .
EXAMPLE 2 A nurse-call button that is easy to push with appropriate strength.
c) Designing home healthcare products for measuring health conditions such as a thermometer, blood
pressure meter, body weight meter, to accommodate a variety of physical structures and conditions
of users.
NOTE 13 Some people with a lean body have difficulty in tightly holding a thermometer under the arm.
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ISO/DTR 25555:2023(E)
NOTE 24 Some people with slender arms or too thick arms have difficulty in wrapping the sensor belt of a blood
pressure meter.
NOTE 35 Some people are not able to measure the body weight due to the difficulty of keeping a steady standing
posture on a body weight meter.
EXAMPLE 3 A thermometer developed for a lean person to hold it under his/her armpit (see B.2.4).
d) Designing home healthcare products which require stepping or pushing by foot so that they are easy-
to-operate with appropriate size and force.
EXAMPLE 14 A manual aspirator operated by foot in an emergency.
EXAMPLE 25 Lid opening of a garbage container operated by a foot pedal.
e) Avoidance of fine dexterity in operation of home healthcare products.
EXAMPLE 16 A large dial or a large button easy-to-pinch or easy-to-push.
EXAMPLE 27 Spatially sparse arrangement of controls but not tightly packed.
EXAMPLE 38 A large-size injection easy to hold.
EXAMPLE 49 A large dialling of an oxygen supplying device easy to operate (see B.2.6).
f) Keeping home healthcare products clean and disinfected, particularly those that are repeatedly used.
NOTE 6 IEC 60601--1-11:2015+AMD1:2020, 7.4.7, 8.1, and 8.2 provide requirements for cleaning,
[22]
disinfection, and sterilization .
EXAMPLE 10 An indication of maximum repeated times of use for a tube attached to the aspirator, or a tube-
feeding nutrient.
g) Labelling or making of home healthcare products or parts of the products to show they are used,
cleaned, disinfected, or sterilized.
h) Avoidance of a sharp point, a sharp edge or a rough surface that occasionally causes an injury to
user’s hands or fingers when they operate the home healthcare products.
NOTE 7 People with epidermolysis bullosa and most of older persons with dry skin in the home healthcare
situation have vulnerable skin and are easy tocan easily be injured by a sharp point, a sharp edge and a rough
surface of a product or even by a seam of clothes.
[3]
i) Avoidance allergy in operating home healthcare products. See ISO/IEC Guide 71:20012014, 8.19 .
EXAMPLE 111 Not using materials that cause nickel or rubber allergy.
EXAMPLE 212 Care for air quality to avoid respiratory allergy.
j) Providing easy mechanisms and notification of timing to users for disposal of home healthcare
products, if disposal is necessary.
NOTE 18 IEC 60601--1-11:2015+AMD1:2020, 7.4.9 provides a requirement for environmental protection for
[22]
disposal of medical goods .
NOTE 29 A used article collection system by companies or proper authorities is relevant for environmental
protection.
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ISO/DTR 25555:2023(E)
EXAMPLE 113 Packaging easy to fold or easy to tear-off for disposal after use.
EXAMPLE 214 Products that can easily detach or tear-off parts for disposal.
k) Ease of opening without any specific tools for tightly-sealed packaging of high cleanliness or
disinfected products.
l) Protection against strangulation or asphyxiation by wires or other similar devices.
NOTE 10 IEC 60601--1-11,:2015+AMD1:2020, Clause 11 provides a requirement for strangulation or
[22]
asphyxiation by wires .
m) Providing easy assemble or connection of parts of home healthcare products by using visual
(pictorial), auditory (spoken) or tactile instruction.
n) Storing home healthcare products at a fixed or a common place for reuse with a marking of
conspicuous labels for easy finding and taking out.
o) Home healthcare products that can be used in mobile environment.
EXAMPLE 15 Use with a wheelchair.
p) Home healthcare products that can be used by a single hand, left-handed or right-handed.
EXAMPLE 16 A walking assisting cane for both right-handed and left-handed grip (see B.2.8).
q) Providing information by multiple means of presentation which is required for the proper working
of home healthcare products, such as changes of working status, refilling consumable items, needs
for maintenance, and scheduled or non-scheduled.
r) Continuous working of home healthcare products without any intermission even in case of disaster
or power service failure (see B.2.6).
5.2 Information and marking
5.2.1 General considerations
Providing information and marking of home healthcare products which are visible, audible, and
understandable increases accessibility and usability of the products. Clear and understandable meaning
...