SIST EN ISO 11608-7:2017

SLOVENSKI STANDARD
SIST EN ISO 11608-7:2017
01-oktober-2017
3HUHVD]DLQMLFLUDQMH]DXSRUDERYPHGLFLQL=DKWHYHLQSUHVNXVQHPHWRGHGHO
=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
SIST EN ISO 11608-7:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11608-7:2017

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SIST EN ISO 11608-7:2017


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.

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SIST EN ISO 11608-7:2017
EN ISO 11608-7:2017 (E)
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

2

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SIST EN ISO 11608-7:2017
EN ISO 11608-7:2017 (E)
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.
3

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SIST EN ISO 11608-7:2017
EN ISO 11608-7:2017 (E)
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
4

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SIST EN ISO 11608-7:2017
EN ISO 11608-7:2017 (E)
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.
5

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SIST EN ISO 11608-7:2017

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SIST EN ISO 11608-7:2017
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

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SIST EN ISO 11608-7:2017
ISO 11608-7:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 11608-7:2017
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 2016 – All rights reserved iii

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SIST EN ISO 11608-7:2017
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

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SIST EN ISO 11608-7:2017
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.
© ISO 2016 – All rights reserved v

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SIST EN ISO 11608-7:2017
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 2016 – All rights reserved 1

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SIST EN ISO 11608-7:2017
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

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SIST EN ISO 11608-7:2017
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’ int
...