SIST EN ISO 11608-7:2017

SLOVENSKI STANDARD
01-oktober-2017
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=DKWHYH]DSULSRPRþNH]DRVHEH]RNYDURYLGD,62
Needle-based injection systems for medical use - Requirements and test methods - Part
7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 7: Anforderungen an die Barrierefreiheit für Menschen mit
Sehbehinderung (ISO 11608-7:2016)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 7: Accessibilité pour les personnes malvoyantes (ISO 11608-7:2016)
Ta slovenski standard je istoveten z: EN ISO 11608-7:2017
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.180.30 3ULSRPRþNL]DVOHSHLQ Aids for blind or partially
VODERYLGQH sighted people
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11608-7
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2017
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 7: Accessibility for
persons with visual impairment (ISO 11608-7:2016)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 7: Accessibilité Verwendung - Anforderungen und Prüfverfahren - Teil
pour les personnes malvoyantes (ISO 11608-7:2016) 7: Anforderungen an die Barrierefreiheit für Menschen
mit Sehbehinderung (ISO 11608-7:2016)
This European Standard was approved by CEN on 9 July 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-7:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
The text of ISO 11608-7:2016 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 11608-7:2017 by Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2018, and conflicting national standards
shall be withdrawn at the latest by February 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11608-7:2016 has been approved by CEN as EN ISO 11608-7:2017 without any
modification.
The following referenced documents are indispensable for the application of this document.
For undated references, the latest edition of the referenced document (including any amendments)
applies. For dated references, only the edition cited applies. However, for any use of this standard
‘within the meaning of Annex ZA’, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the EN                    ISO  or  IEC
ISO
standard
ISO 11608-1:2014 EN ISO 11608-1:2015 ISO 11608-1:2014
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
IEC 62366-1 EN 62366-1:2015 + AC:2015 IEC 62366-1:2015 + Cor 1:2016
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/295
concerning the development of European standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 – Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Clause(s) / sub-clause(s) Remarks/Notes
Essential Requirements of
Directive 93/42/EEC
of this EN ISO 11608-7
7.2 4.2.2 Clause 4.2.2 of the standard
only meets the requirements
or ER 7.2 in respect of
packaging design, and then
only for opening the
packaging, and spillage of the
contents.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 11608-7
First edition
2016-08-01
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 7:
Accessibility for persons with visual
impairment
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 7: Accessibilité pour les personnes malvoyantes
Reference number
ISO 11608-7:2016(E)
©
ISO 2016
ISO 11608-7:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Risk analysis requirements . 3
4.2 General requirements . 3
4.2.1 NIS design . 3
4.2.2 Packaging design. 4
5 Test methods . 4
5.1 Verification testing . 4
5.2 Summative evaluation (validation testing) . 5
5.2.1 General. 5
5.2.2 User populations . 5
5.2.3 Context of use . 5
6 Test report . 5
7 Information supplied by the manufacturer . 6
7.1 General . 6
7.1.1 Overview . 6
7.1.2 Tactile information . 6
7.1.3 Auditory information . 6
7.1.4 Information provided in electronic format . 6
7.2 Marking . 6
7.2.1 Marking on the NIS . 6
7.2.2 Marking on the unit packaging . 7
7.3 Instructions for use . 7
Annex A (informative) Measuring vision and visual impairment: Functional vision and
visual acuity . 9
Annex B (informative) Guidance for developing instructions for use for persons with
visual impairment .13
Annex C (informative) Process for establishing a specification, test methods and
verification related to 5.1 .15
Bibliography .18
ISO 11608-7:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal
products and catheters.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for
medical use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Needle-based injection systems containing electronics
— Part 5: Automated functions
— Part 6: On-body delivery systems
— Part 7: Accessibility for persons with visual impairment
iv © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
Introduction
Prior to this part of ISO 11608, the ISO 11608 series has not provided guidance to address the use of NIS
by persons with visual impairment. The reality, however, is that a significant number of NIS users have
visual impairments and operate these devices, even though the user interfaces rely primarily on visual
communication to provide the information needed for safe and effective use. The result is that users
with visual impairment have difficulty and may be at greater risk when using these products.
Given the prevalence of visual impairment and the fact that many NIS target disease states (e.g.
diabetes) with co-morbid conditions that can impair vision, efforts should be made to eliminate or
minimize, where possible, device features that constitute obstructions to product use for users with
visual impairment.
This part of ISO 11608 defines terms related to visual impairment and provides guidance to enable
manufacturers to provide information to the user in other sensory formats (e.g. tactile, auditory). New
and existing features that address the needs of users with visual impairment will also benefit a broader
population.
The purpose of this part of ISO 11608 is to assist manufacturers in developing NIS designs that will be
usable for users with visual impairment but recognizes that those designs could be more usable also
[29]
for users with no visual impairment. Taking this type of “universal design” approach is preferable to
the creation of “niche” products only for users with visual impairment, for which the market would be
smaller and, consequently, the product cost likely would be higher. Applying universal design principles
to extend access to users with visual impairment can increase the market size, thereby reducing
product cost and enabling a broader patient population to access the NIS.
For product design purposes, it should be assumed that some users will have moderate visual
impairment but will be able to read large print and see high-contrast product features. Other users,
however, will not be able to make use of any visual features and will instead require information to
be provided through other sensory means (e.g. tactile or auditory). Therefore, this part of ISO 11608
includes the requirement to provide information in visual formats that can be perceived and understood
by people with moderate visual impairment and in non-visual formats (e.g. tactile or auditory) that can
be perceived and understood by people with no useful vision.
In conjunction with other parts of the ISO 11608 series, manufacturers are expected to follow a
risk-based approach and employ human factors engineering during the design, development, and
manufacture of NIS serving this important user population. Existing products and those currently
under development may not fulfil some of the requirements given by this part of ISO 11608. However,
manufacturers would be well advised to follow its provisions when improving existing products or
developing new products to obtain a higher level of accessibility.
Guidance on transition periods for implementing the requirements of this International Standard is
given in ISO/TR 19244.
INTERNATIONAL STANDARD ISO 11608-7:2016(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 7:
Accessibility for persons with visual impairment
1 Scope
This part of ISO 11608 specifies particular requirements to make needle-based drug delivery systems
or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to
devices intended for patient or caregiver administration of medicinal products to humans.
This part of ISO 11608 covers requirements to allow for safe and correct handling of the NIS, including
labelling, packaging, and instructions for use. It also includes requirements for training programs, if
applicable.
This part of ISO 11608 covers requirements for NIS that are claimed to be appropriate for use by
persons with visual impairments.
This part of ISO 11608 does not address requirements for use of sharps containers by persons with
visual impairments.
Although specifically intended to apply to needle-based injection systems within the ISO 11608 series,
this part of ISO 11608 can be applied to NIS outside the ISO 11608 series as well, if they might be used
by persons with visual impairments.
This part of ISO 11608 is written to address the needs of persons with all levels of visual limitations,
including low, moderate, or severe visual impairment; legal, functional, or total blindness; and colour
vision deficiencies.
Therefore, this part of ISO 11608 includes the requirement to provide information in visual formats
that can be perceived and understood by people with moderate visual impairment and in non-visual
formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision.
For simplicity’s sake, this range is described in this part of ISO 11608 as addressing the needs of
individuals with moderate visual impairment or blindness.
NOTE NIS that are not claimed to be appropriate for use by persons with visual impairments need not meet
these requirements, but manufacturers are encouraged to consider them.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 11608-1:2014, Needle-based injection systems for medical use — Requirements and test methods —
Part 1: Needle-based injection systems
ISO 14971, Medical devices — Application of risk management to medical devices
1)
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
1) Replaces IEC 62366.
ISO 11608-7:2016(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
colour vision deficiency
inability to distinguish certain shades of colour or in more severe cases, see colours at all
3.2
blindness
visual acuity (3.10) less than 3/60
Note 1 to entry: Having no useful vision.
Note 2 to entry: See Table A.1.
3.3
functional vision
way in which a person functions when attempting visual tasks, such as reading, orientation and
mobility, activities of daily living, visual communication, and visual job skills
3.4
functional visual impairment
significant limitation of visual capability that cannot be improved by corrective lenses, medications, or
surgery, and results in difficulty accomplishing visual tasks that are important to the individual
Note 1 to entry: See Annex A.
3.5
moderate visual impairment
visual acuity (3.10) between 6/18 and 6/60
Note 1 to entry: See Table A.1.
3.6
needle-based injection system
NIS
injection system intended for parenteral administration by injection of medicinal products using a
needle and a multi-dose or single-dose container
[SOURCE: ISO 11608-1:2014, 3.9]
3.7
non-visual means
format that utilizes a sensory channel other than vision
Note 1 to entry: Braille is not widely used; therefore, it is not recommended as the only tactile format.
Note 2 to entry: Examples of non-visual means are channels for e.g. tactile, auditory, olfactory sensors.
3.8
severe visual impairment
visual acuity (3.10) between 6/60 and 3/60
Note 1 to entry: See Table A.1.
3.9
user interface
means by which the user and the medical device interact
[SOURCE: IEC 62366-1:2015, 3.26, modified]
2 © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
3.10
visual acuity
sharpness of vision expressed as a fraction of normal vision
Note 1 to entry: See Annex A.
EXAMPLE The notation “6/12” means that a specific person can distinguish an image at a distance of 6 m
that a person with normal vision could distinguish at a distance of 12 m.
3.11
visual impairment
sight loss that cannot be improved by corrective lenses
Note 1 to entry: Corrective lenses can be glasses or contact lenses.
4 Requirements
4.1 Risk analysis requirements
The manufacturer’s risk assessments shall consider risks associated with the intended use of the NIS
for medical purposes, including use by individuals without visual impairment, as well as individuals
with moderate visual impairment and individuals with blindness.
When conducting the risk assessment, it is important to accurately identify all user groups of the NIS
and any functional characteristics of each group that could affect their use of the NIS. Some disease
conditions (e.g. diabetes) and some medications (e.g. thorazine) can cause visual impairments and some
user groups (e.g. elderly adults, who might be the patient or a lay caregiver) are more likely to have
visual impairment. Some users of the NIS might have colour deficiency, which could be associated with
other types of risks. If there is a possibility of visual impairment amongst the NIS user groups, analysis
of the potential effects of those impairments on the users’ interactions with the NIS shall be included in
the risk assessment.
As part of the risk analysis conducted according to ISO 14971, the manufacturers shall identify all use
scenarios that could lead to a hazardous situation or harm and then implement risk control measures
needed to reduce the risks to acceptable levels. The adequacy of the risk control measures shall be
assessed in the summative evaluation of the NIS. See 5.2.
The assessment of the risks and benefits associated with use of the NIS shall consider the fact that
for users with visual impairment, the risks might be different from the risks for users without visual
impairment. The analysis of risks shall include handling of the NIS, accurate dosing of the specific
drug, and understanding of the information supplied by the manufacturer. While the benefits of the
medicinal product are the same for both user groups, the benefits could be greater for users with visual
impairment due to the ability to self-administer the medicinal product.
4.2 General requirements
4.2.1 NIS design
The NIS shall be designed so that a user with moderate visual impairment or blindness can use it safely
and correctly for its intended purpose, including, where applicable, filling the NIS with medicinal
product and assembling components. The requirements in this Clause may be fulfilled through the use
of an accessory (e.g. separate device or mobile application).
NIS shall clearly indicate and distinguish the following states by visual and non-visual means, i.e.
providing equivalent information in other sensory formats, such as tactile and/or audible formats:
— unused;
— ready to deliver;
ISO 11608-7:2016(E)
— delivery initiated;
— delivery completed;
— end of useful life.
NOTE 1 ISO 11608-5 uses the term “in use”, which includes three of the states listed above: “ready to deliver,
delivery initiated, and delivery completed”.
The NIS design shall meet the following requirements.
a) The visual and non-visual information shall be consistent with each other. State indicators shall be
persistent or confirmable by the user while the NIS is in that state. Where applicable, the NIS shall
allow the user to determine the deliverable dose by visual and non-visual means.
NOTE 2 Information presentation can be either persistent (constant) or transient (temporary). For
example, a continuous audible tone would be persistent, whereas a single click or “beep” would be transient.
b) The NIS shall allow the user to assess the appearance of the medicinal product by visual means, e.g.
through assistance from a sighted person, and where possible, non-visual means.
When the NIS requires the user to pre-set the dose, or the manufacturer pre-sets the dose, the NIS
shall provide an indication through visual and non-visual means of the dose that has been set.
c) Variable multi-dose NISs (system designations A and C, as defined in ISO 11608-1) shall be designed
so that they indicate, through visual and non-visual means, either the amount of the pre-set dose
delivered or the amount of the pre-set dose not yet delivered.
d) If the NIS contains batteries, it shall be designed to allow the user to determine the remaining
battery charge by visual and non-visual means.
e) The NIS shall enable the user to safely identify the location from which sharps will project using
visual and non-visual means. Where retraction of the needle from the injection site is automatic,
indication of the completion of needle retraction shall be provided by non-visual means. If a tactile
means is used to identify and verify status of the needle, it shall be designed in such a way that the
use of the tactile means itself will not lead to increasing risk of needle stick injury.
4.2.2 Packaging design
The NIS packaging shall be designed so that a user with moderate visual impairment or blindness can
open it safely and correctly, without being harmed or damaging the NIS.
Features provided to facilitate opening the packaging shall be readily apparent by visual and at least
one non-visual means.
The packaging shall be designed to prevent inadvertent spillage of the package contents once the
packaging is opened.
If assembly of the NIS is required, the components shall be packaged in a way that facilitates correct
identification and assembly.
5 Test methods
5.1 Verification testing
Testing shall be conducted to verify that the NIS design was implemented in accordance with the design
specifications, including those features that make the NIS safe and effective for users with visual
impairment.
4 © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
Specifications for functions related to accessibility, such as operating ranges, maximum and/or minimum
levels, and dimensional values of technical parameters shall be verified. For further information, see
Annex C.
While lab-based testing and measurement of the accessibility-related user interface features can form
part of a verification program for the product, NIS manufacturers shall be aware that appropriate
formative and summative validation will provide final evidence that the intended users can use the NIS
safely and correctly.
5.2 Summative evaluation (validation testing)
5.2.1 General
Where the intended user groups are identified as including people with visual impairment, such users
shall be included in summative evaluation conducted on the NIS and its packaging and labelling.
The summative evaluation of the NIS shall be conducted according to IEC 62366-1 and include the user
populations and context of use.
5.2.2 User populations
Summative evaluation of a NIS that follows this part of ISO 11608 shall include the intended users.
For the purposes of recruiting people with visual impairment to participate in summative evaluation of
a NIS, and characterizing their level of impairment, measuring functional vision might be simpler and
more appropriate and useful than measuring visual acuity. Standardized instruments are available for
this purpose. The manufacturer shall provide a rationale for their choice to measure either functional
vision or visual acuity, and the specific measurement instrument selected. See Annex A.
5.2.3 Context of use
The context of use for the NIS shall be considered in the risk assessment. All aspects of the context of
use that could affect users’ ability to use the NIS safely and correctly shall be incorporated into the
summative evaluation.
Aspects of the context of use that are particularly important to users with visual impairment include
any environmental conditions that could affect users’ perception of information. For example, lighting
conditions (e.g. low light or glare) can affect the ability of users with moderate visual impairment
to perceive visual information provided by the user interface. Ambient noise levels and acoustic
characteristics of the environment (e.g. reverberation) can affect the ability of users to perceive
auditory information provided by the user interface. Cold temperatures can affect users’ ability to
perceive tactile information.
Another aspect of the context of use that is particular to users with visual impairments is use of assistive
technologies. Some users will use glasses or magnifying technologies to perceive visual information.
Some users will use sound amplifiers to perceive auditory information.
6 Test report
See ISO 11608-1 and IEC 62366-1.
ISO 11608-7:2016(E)
7 Information supplied by the manufacturer
7.1 General
7.1.1 Overview
All visual information required for safe and effective use of the NIS shall be perceptible and
comprehensible to users with moderate visual impairment. Users with blindness shall be able to
access the same information through non-visual means. The visual and non-visual information shall be
consistent with each other.
7.1.2 Tactile information
Information can be communicated through tactile means.
Tactile information can be provided in formats such as raised characters, vibration, distinctly shaped
controls, braille, and other features. The effects of degenerative diseases and neuropathy in the patient
population of the intended NIS shall be considered in the design of any tactile communication methods.
NOTE See ISO/TR 22411:2008, 8.2.2.1 for guidance on suitable tactile markings. ISO/TR 22411:2008,
9.2.3.2, 9.2.3.3 and 9.2.4 provide guidance on the spatial and temporal resolution of the tactile sense, as well as
the thermal sense. ISO 24503 provides requirements for improving the accessibility of consumer products used
by persons with visual impairment, and in cases where visual information is not the primary sense used for
accomplishing the task.
7.1.3 Auditory information
Information can be communicated by auditory means.
Auditory information can be provided in formats such as synthesized or recorded speech, melodies,
clicking, beeping, or buzzing.
NOTE See ISO/TR 22411:2008, 8.2.2.2 for guidance on effective design of auditory feedback. ISO 24500
provides guidance for improving the usability and accessibility of auditory signals used in consumer products,
thereby facilitating use by all people, including people with visual impairments and older people with age-
related hearing impairments. ISO 24501 specifies methods for determining an appropriate sound level range for
auditory signals, so that all product users, including people with age-related hearing loss, can hear them properly
against interfering sounds.
7.1.4 Information provided in electronic format
Information can be communicated through electronic means.
Electronic information can be provided in formats such as codes or signals intended to interact with
hand-held devices, dedicated readers, or assistive technologies.
NOTE One example of an electronic marking is a QR (quick response) code, which is a form or optically
machine-readable image that conveys information such as text or a website address. ISO/IEC 18004 defines the
requirements for the symbology, known as QR Code 2005.
7.2 Marking
7.2.1 Marking on the NIS
The NIS markings shall enable the user to access the same information required in ISO 11608-1:2014,
13.2.2, by non-visual means.
6 © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
Flashing, blinking, scrolling, or flickering displays can be difficult for users with moderate visual
impairment to read. Distracting or unnecessary information should not be presented to the user.
NOTE 1 The following International Standards provide useful guidance:
— ISO/TR 22411:2008, 8.5, 8.6 and 8.8 provide useful guidance on improving legibility and comprehension of
text and graphic markings.
— ISO 24502 provides a method of calculating age-related luminance contrast that can be used for assessing
and designing signs and visual displays so that they are clearly visible to older people.
NOTE 2 The risk assessment could indicate that the NIS markings should enable the user to distinguish it from
similar NIS in the same environment.
7.2.2 Marking on the unit packaging
The markings on the packaging shall enable the user to access the same information required in
ISO 11608-1:2014, 13.2.3 by visual and at least one non-visual means.
Markings shall be readily locatable by non-visual means and compatible with assistive reading
technologies.
NOTE Technologies that might be used to read the packaging markings include assistive reading technologies
that utilize machine-readable code, web browser links to websites, telephone, and/or magnification.
7.3 Instructions for use
All information in the instructions for use shall be available to users with visual impairment.
This information shall be provided through visual means usable by persons with moderate visual
impairment and through at least one non-visual means.
The instructions for use shall include information in clear language to facilitate use of the NIS by
persons with visual impairment, including reference to all non-visual information provided by and
markings on the NIS. For example, where applicable, the following information shall explain how to,
safely and correctly,
— remove the parts of the NIS from the packaging,
— identify the parts of the NIS and necessary consumable components and assemble them correctly,
— determine how much medicinal product is in the NIS,
— fill the device with the medicinal product,
— combine separate components of medicinal products,
— conduct priming steps or other dose delivery preparation,
— set the dosage in the NIS,
— deliver a complete dose with the NIS,
— determine how much medicinal product was delivered by the NIS,
— remove and reinstall replaceable components,
— disassemble the NIS,
— dispose of the NIS or consumable components,
— detect the correct orientation of the battery or batteries, and
— perform troubleshooting.
ISO 11608-7:2016(E)
NOTE See ISO/TR 22411:2008, 8.7 for guidance on written and spoken communication. ISO 11156 provides
general guidance on increasing accessibility of packages and packaged products.
Additional information to consider when developing instructions for use for persons with visual
impairment is given in Annex B.
If it is not possible to provide information necessary for safe and effective use of the NIS using non-
visual means, e.g. inspection of the primary packaging and drug product, this possibility shall be
considered as part of the risk assessment.
8 © ISO 2016 – All rights reserved

ISO 11608-7:2016(E)
Annex A
(informative)
Measuring vision and visual impairment: Functional vision and
visual acuity
A.1 General
Two distinctively different methods can be used to describe or measure vision and visual impairment:
[5][6][7]
functional vision and visual acuity .
— Functional vision describes how well a person functions when attempting visual tasks such as
reading, orientation and mobility, activities of daily living, visual communication, and visual
job skills. It can be measured directly, by observation of the person performing a defined set of
[5]
standardized visual tasks, or indirectly through a visual function questionnaire .
— Visual acuity is a measurement of how well an eye functions when a person attempts to see. It is
the sharpness of vision expressed as a fraction of normal vision. It can be measured using an eye
chart, optical instruments, or computerized tests. All of these tests should be adm
...