BS EN ISO 9999-2016 Assistive products for persons with disability Classification and terminology《残疾人用辅助产品 分类和术语》.pdf

1、BS EN ISO 9999:2016Assistive products forpersons with disability Classification and terminology(ISO 9999:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 9999:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO

2、 9999:2016. It supersedes BS EN ISO 9999:2011 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/173/-/2, Classification and Terminology of Assistive Products.A list of organizations represented on this committee can be obtained on request to its secre

3、tary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 85593 1 ICS 11.180.01 Compliance with a British Standard canno

4、t confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9999

5、November 2016 ICS 11.180.01 Supersedes EN ISO 9999:2011English Version Assistive products for persons with disability - Classification and terminology (ISO 9999:2016) Produits dassistance pour personnes en situation de handicap - Classification et terminologie (ISO 9999:2016) Hilfsmittel fr Menschen

6、 mit Behinderungen - Klassifikation und Terminologie (ISO 9999:2016) This European Standard was approved by CEN on 29 August 2016. 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 stand

7、ard 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 an

8、y 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 Repu

9、blic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN

10、COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9999:2016 EBS EN

11、ISO 9999:2016EN ISO 9999:2016 (E) 3 European foreword This document (EN ISO 9999:2016) has been prepared by Technical Committee ISO/TC 173 “Assistive products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” the secret

12、ariat of which is held by SIS. 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 May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the

13、possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9999:2011. According to the CEN-CENELEC Internal Regulations, the national stand

14、ards 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, Lu

15、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 9999:2016 has been approved by CEN as EN ISO 9999:2016 without any modification. BS EN ISO 9999:2016ISO 9999:2016(E)Forew

16、ord ivIntroduction v1 Scope . 12 Terms and definitions . 13 Principle 34 Elements and rules used in classification 34.1 Construction 34.2 Codes . 34.3 Titles of classes, subclasses and divisions . 44.4 Rules used in classification . 45 Index 56 Classification 56.1 One-level classification Classes .

17、56.2 Two-level classification Classes and subclasses . 56.3 Three-level, detailed classification with explanations, inclusions, exclusions and references 10Annex A (informative) Membership of ISO 9999 in the WHO Family of International Classifications . 107Annex B (informative) Definition of assisti

18、ve product and the standard title .108Annex C (informative) Conversion table between ISO 9999:2011 and ISO 9999:2016 109Annex D (informative) Alphabetical index 138Bibliography . 194 ISO 2016 All rights reserved iiiContents PageBS EN ISO 9999:2016ISO 9999:2016(E)ForewordISO (the International Organi

19、zation 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 establishe

20、d 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.T

21、he 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

22、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

23、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 e

24、xplanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee r

25、esponsible for this document is ISO/TC 173, Assistive products for persons with disability, Subcommittee SC 2, Classification and terminology.This sixth edition cancels and replaces the fifth edition (ISO 9999:2011), which has been technically revised.iv ISO 2016 All rights reservedBS EN ISO 9999:20

26、16ISO 9999:2016(E)IntroductionAssistive products (including software) are classified according to their function. The classification consists of three hierarchical levels and the codes each consist of three pairs of digits. Like other classifications, for each level, codes, titles, explanatory notes

27、, inclusions, exclusions and cross-references are given. Besides the explanatory text and the classification itself, a table of conversion between the previous edition (2011) and this edition and an alphabetical index are provided in order to facilitate the use of and to improve the accessibility of

28、 the classification.This edition has 945 titles of which about 44 are new and 456 are changed, including minor editorial and grammatical revisions.All assistive products in this classification are primarily intended for use outside of health care settings; however, some of the products can be used i

29、n facilities such as rehabilitation centres to teach clients how to use these products. It should be noted that the titles of some subclasses and divisions in class 28 refer to the “workplace”. This term does not refer to a specific setting or geographical location; instead, it refers to any setting

30、 in which employment-related activities or vocational training are performed.The definition of “assistive product” used by this International Standard has been revised to align it with the terminology of the International Classification of Functioning, Disability and Health (ICF).Relation to the WHO

31、 Family of International ClassificationsIn 2003, ISO 9999 was accepted as a related member of the WHO Family of International Classifications (WHO-FIC). The WHO-FIC comprises high-quality classifications for relevant sectors of the health system. With this inclusion, the use of this International St

32、andard was stimulated.This International Standard makes use of the terminology of the International Classification of Functioning, Disability and Health (ICF, WHO, 2001). ICF is a classification of health and health-related domains. These domains are classified from body, individual and societal per

33、spectives by means of two lists: a list of body functions and structure and a list of domains of activity and participation. Since an individuals functioning and disability occurs in a context, ICF also includes a list of environmental factors. The ICF is one of the core classifications of the WHO-F

34、IC (see Annex A).A major change in this edition is a change of the titles of the classes to bring them in harmony with the terminology of the ICF.Proposal for changesProposals for changes or additions to this International Standard, both in respect of existing and proposed new classes/subclasses/div

35、isions, which take into account the given rules for classification, may be submitted to a national member body of ISO with an accompanying explanation for the proposal. See http:/www.iso.org for addresses of national member bodies.NOTE 1 Some of the assistive products for persons with disability can

36、 be classified as medical devices.NOTE 2 National member bodies are encouraged to improve the accessibility of the classification by the addition of national language synonyms to the nationally implemented standard. ISO 2016 All rights reserved vBS EN ISO 9999:2016BS EN ISO 9999:2016Assistive produc

37、ts for persons with disability Classification and terminology1 ScopeThis International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability.Assistive products used by a person with disability, but which r

38、equire the assistance of another person for their operation, are included in the classification.The following items are specifically excluded from this International Standard: items used for the installation of assistive products; solutions obtained by combinations of assistive products that are ind

39、ividually classified in this International Standard; medicines; assistive products and instruments used exclusively by healthcare professionals; non-technical solutions, such as personal assistance, guide dogs or lip-reading; implanted devices; financial support.2 Terms and definitionsFor the purpos

40、es of this document, the following terms and definitions apply.2.1activityexecution of a task or action by an individualSOURCE: ICF 2001, WHO2.2activity limitationsdifficulties an individual can have in executing activitiesSOURCE: ICF 2001, WHO2.3assistive productany product (including devices, equi

41、pment, instruments and software), especially produced or generally available, used by or for persons with disability (2.12) for participation (2.13), to protect, support, train, measure or substitute for body functions (2.4)/structures and activities, or to prevent impairments (2.11), activity limit

42、ations (2.2) or participation restrictions (2.14)Note 1 to entry: The definition of assistive product is in discussion at the GATE, the Global cooperation on Assistive Health Technology (a WHO initiative), and the information is given in Annex B.INTERNATIONAL STANDARD ISO 9999:2016(E) ISO 2016 All r

43、ights reserved 1BS EN ISO 9999:2016ISO 9999:2016(E)2.4body functionsphysiological functions of body systems (including psychological functions)SOURCE: ICF 2001, WHO2.5body structuresanatomical parts of the body such as organs, limbs and their componentsSOURCE: ICF 2001, WHO2.6classificationsystem of

44、 concepts or a structured set of concepts established according to the relations between them, each concept being determined by a systematic code and its positions in the system of concepts2.7classcollection of similar articles, divided according to definite and chosen rules2.8disabilityumbrella ter

45、m for impairments (2.11), activity limitations (2.2) and participation restrictions (2.14) denoting the negative aspects of the interaction between an individual (with a health condition) and that individuals contextual factors (environmental and personal factors)SOURCE: ICF 2001, WHO2.9environmenta

46、l factorsphysical, social and attitudinal environment in which people live and conduct their livesSOURCE: ICF 2001, WHO2.10functioningumbrella term for body functions (2.4), body structures (2.5), activities and participation (2.13) denoting the positive aspects of the interaction between an individ

47、ual (with a health condition) and that individuals contextual factors (environmental and personal factors)SOURCE: ICF 2001, WHO2.11impairmentsproblems in body function or structure, such as a significant deviation or lossSOURCE: ICF 2001, WHO2.12person with disabilityperson with one or more impairme

48、nts (2.11), one or more activity limitations (2.2), one or more participation restrictions (2.14) or a combination thereof2.13participationinvolvement in a life situationSOURCE: ICF 2001, WHO2 ISO 2016 All rights reservedBS EN ISO 9999:2016ISO 9999:2016(E)2.14participation restrictionsproblems an in

49、dividual can experience in involvement in life situationsSOURCE: ICF 2001, WHO2.15workplacedefined area or areas in which the work activities are carried outSOURCE: EN 1540:19983 PrincipleThe classification is based on the function of the products being classified.In particular, it should be noted that assistive products, which are used exclusively for training in skills, are included in class 05. Assistive products that have a principal function other than training, but which can also be used for training, are include