1、Needle-based injection systems for medical use - Requirements and test methodsPart 7: Accessibility for persons with visual impairmentBS EN ISO 116087:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation
2、of EN ISO 116087:2017. It is identical to ISO 116087:2016.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to
3、include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 81012 1ICS 11.040.25Compliance with a British Standard cannot confer immunity from legal obligations.Thi
4、s British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 116087:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11608-7August 2017ICS 11.0
5、40.25EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 116087:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national M
6、embersNeedlebased injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment (ISO 116087:2016)Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 7: Accessibilit pour les personnes malvoyantes (ISO 116087:2016
7、)Kanlenbasierte Injektionssysteme zur medizinischen Verwendung Anforderungen und Prfverfahren Teil 7: Anforderungen an die Barrierefreiheit fr Menschen mit Sehbehinderung (ISO 116087:2016)This European Standard was approved by CEN on 9 July 2017.CEN members are bound to comply with the CEN/CENELEC I
8、nternal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the CENCENELEC Management Centre or to any
9、 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 ver
10、sions.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,
11、Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 11608-7:2017 (E)European forewordThe text of ISO 116087:2016 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and cat
12、heters” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 116087:2017 by Technical Committee CEN/TC 205 “Nonactive medical devices” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by p
13、ublication 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
14、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 informa
15、tive Annex ZA, which is an integral part of this document.According to the CENCENELEC 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, Fi
16、nland, 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
17、text of ISO 116087:2016 has been approved by CEN as EN ISO 116087:2017 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 date
18、d 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 stateofart.When an I
19、EC 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 n
20、ormative requirements determines the extent (in whole or in part) to which they apply.Table Correlation between normative references and dated EN and ISO standardsNormative referencesas listed in Clause 2 of the ISO standard Equivalent dated standardEN ISO or IEC ISO 116081:2014 EN ISO 116081:2015 I
21、SO 116081:2014 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 IEC 623661 EN 623661:2015 + AC:2015 IEC 623661:2015 + Cor 1:20162BS EN ISO 116087:2017ISO 11608-7:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Requirements 34.1 Risk analysis requirements 34.
22、2 General requirements . 34.2.1 NIS design 34.2.2 Packaging design 45 Test methods . 45.1 Verification testing . 45.2 Summative evaluation (validation testing) 55.2.1 General 55.2.2 User populations 55.2.3 Context of use . 56 Test report . 57 Information supplied by the manufacturer . 67.1 General .
23、 67.1.1 Overview . 67.1.2 Tactile information . 67.1.3 Auditory information . 67.1.4 Information provided in electronic format . 67.2 Marking . 67.2.1 Marking on the NIS 67.2.2 Marking on the unit packaging 77.3 Instructions for use . 7Annex A (informative) Measuring vision and visual impairment: Fu
24、nctional vision and visual acuity . 9Annex B (informative) Guidance for developing instructions for use for persons with visual impairment .13Annex C (informative) Process for establishing a specification, test methods and verification related to 5.1 15Bibliography .18 ISO 2016 All rights reserved i
25、iiContents PageBS EN ISO 116087:2017ISO 11608-7:2016(E)ForewordISO (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.
26、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 nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Internati
27、onal 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 differen
28、t 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 no
29、t 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 inf
30、ormation 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 ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see
31、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 Requirement
32、s 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 r
33、ights reservedBS EN ISO 116087:2017ISO 11608-7:2016(E)IntroductionPrior 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 o
34、perate 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 visu
35、al impairment and the fact that many NIS target disease states (e.g. diabetes) with comorbid 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 I
36、SO 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 populat
37、ion.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 for users with no visual impairment. Taking this type of “universal design”29approach is pre
38、ferable 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, the
39、reby 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 highcontrast product features. Other users, however, will not be
40、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
41、moderate visual impairment and in nonvisual 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 riskbased approach and employ human factors engineering
42、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 i
43、mproving 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 vBS EN ISO 116087:2017This page deliberately left bl
44、ankNeedle-based injection systems for medical use - Requirements and test methods Part 7: Accessibility for persons with visual impairment1 ScopeThis part of ISO 11608 specifies particular requirements to make needle-based drug delivery systems or NIS (needlebased injection system) accessible for pe
45、rsons 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 includ
46、es 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.A
47、lthough 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
48、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 und
49、erstood by people with moderate visual impairment and in nonvisual formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision.For simplicitys 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 consid
