EN ISO 11608-7:2017
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
ISO 11608-7:2016 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.
It 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.
It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.
It 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, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.
It 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, ISO 11608-7:2016 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 ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.
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)
L'ISO 11608-7 :2016 spécifie des exigences spécifiques pour rendre les systèmes d'injection à base d'aiguille à usage médical ou NIS (systèmes d'injection à base d'aiguille) accessibles aux personnes malvoyantes. Elle s'applique aux dispositifs destinés à l'administration de médicaments par le patient ou le soignant chez l'homme.
Elle couvre les exigences permettant une manipulation sûre et correcte du NIS, y compris l'étiquetage, l'emballage et le mode d'emploi. Elle contient également des exigences pour les programmes de formation, le cas échéant.
Elle couvre les exigences concernant les NIS déclarés appropriés aux personnes malvoyantes.
Elle ne traite pas des exigences d'utilisation des conteneurs d'objets piquants, coupants et tranchants par les personnes malvoyantes.
Bien que spécifiquement destinée aux systèmes d'injection à base d'aiguille à usage médical tombant dans le cadre de la série ISO 11608, l'ISO 11608-7 :2016 peut aussi être appliquée aux NIS en dehors de la série ISO 11608, s'ils peuvent être utilisés par des personnes malvoyantes.
Elle a pour but de répondre aux besoins des personnes atteintes de limitations visuelles, et ce quel qu'en soit le niveau, notamment les déficiences visuelles faible, modérée et sévère: la cécité du point de vue légal, fonctionnel ou la cécité totale; et les déficiences de perception des couleurs.
En conséquence, l'ISO 11608-7 :2016 comprend l'exigence de fournir des informations dans des formats visuels pouvant être perçus et compris par les personnes souffrant de déficience visuelle modérée et dans des formats non visuels (par exemple tactiles ou sonores) qui peuvent être perçus et compris par les personnes dépourvues d'une vision utile.
Par souci de simplicité, cette gamme est décrite dans l'ISO 11608-7 :2016 en répondant aux besoins des personnes souffrant de déficience visuelle modérée ou de cécité.
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 7. del: Zahteve za pripomočke za osebe z okvaro vida (ISO 11608-7:2016)
Ta del standarda ISO 11608 določa zahteve za sisteme za dajanje zdravil s peresi za injiciranje, namenjene osebam z okvaro vida. Uporablja se za pripomočke, s katerimi pacienti ali skrbniki dajejo zdravila.
Ta standard zajema zahteve, ki omogočajo varno in pravilno uporabo pripomočka, vključno z označevanjem, pakiranjem in navodili za uporabo. Zajema tudi zahteve za programe usposabljanja, če je to primerno.
Pripomočki, za katere se trdi, da so primerni za osebe z okvaro vida, morajo izpolnjevati veljavne zahteve tega standarda.
Ta standard ne obravnava zahtev za uporabo vsebnikov za ostre pripomočke s strani oseb z okvaro vida.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
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
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
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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 .
...
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