DIN EN ISO 9999-2017 Assistive products for persons with disability - Classification and terminology (ISO 9999 2016) German version EN ISO 9999 2016《残疾人用辅助产品 分类及专业术语(ISO 9999-2016).pdf

1、March 2017 English price group 33No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01.040.11; 11.180.01!%c+“2640894ww

2、w.din.deDIN EN ISO 9999Assistive products for persons with disability Classification and terminology (ISO 9999:2016);English version EN ISO 9999:2016,English translation of DIN EN ISO 9999:2017-03Hilfsmittel fr Menschen mit Behinderungen Klassifikation und Terminologie (ISO 9999:2016);Englische Fass

3、ung EN ISO 9999:2016,Englische bersetzung von DIN EN ISO 9999:2017-03Produits dassistance pour personnes en situation de handicap Classification et terminologie (ISO 9999:2016);Version anglaise EN ISO 9999:2016,Traduction anglaise de DIN EN ISO 9999:2017-03SupersedesDIN EN ISO 9999:201110www.beuth.d

4、eDocument comprises 203 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.17 DIN EN ISO 9999:2017-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 9999:2016) has been prepared by Technical Co

5、mmittee ISO/TC 173 “Assistive products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” (both Secretariats: SIS (Sweden). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Sta

6、ndards Committee Medicine), Working Committee NA 063-06-01 AA Terminologie. In the German version of this edition, the English term “environmental” has been translated throughout with “Umwelt”. This corresponds to the German translation according to DIMI (German Institute of Medical Documentation an

7、d Information) and ICF (International Classification of Functioning); see subclause 2.9 of this standard. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10535 DIN EN ISO 10535 ISO 11199-1 DIN EN ISO 11199-1 ISO 11199-2 DIN EN ISO 11199

8、-2 ISO 11334-1 DIN EN ISO 11334-1 ISO 11334-4 DIN EN ISO 11334-4 EN 1540 DIN EN 1540 EN 12182 DIN EN 12182 Proposed amendments Proposals for changes or additions to this International Standard, both in respect of existing and proposed new classes/subclasses/divisions, which take into account the giv

9、en 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 disabilities can be classified as medical devices co

10、nforming to EU Directive 93/42/EEC of June 1993. DIN EN 12182 includes general requirements for assistive products for persons with disabilities. NOTE 2 National member bodies are encouraged to improve the accessibility of the classification by the addition of national language synonyms to the natio

11、nally implemented standard. Amendments This standard differs from DIN EN ISO 9999:2011-10 as follows: a) classifications have been extended and partly revised; b) Annex B including information on the definition of assistive products and the standard title has been added; DIN EN ISO 9999:2017-03 3 c)

12、 the conversion table between the previous edition (2011) and the current edition which has now been transferred to Annex C has been updated; d) the alphabetical index has been updated and has been included in the standard as Annex D. Previous editions DIN EN 29999: 1994-05 DIN EN ISO 9999: 1998-08,

13、 2003-04, 2007-06, 2011-10 DIN EN ISO 9999 Corrigendum 1: 2009-09 DIN EN ISO 9999:2017-03 4 National Annex NA (informative) Bibliography DIN EN 1540, Workplace exposure Terminology DIN EN 12182, Assistive products for persons with disability General requirements and test methods DIN EN ISO 10535, Ho

14、ists for the transfer of disabled persons Requirements and test methods DIN EN ISO 11199-1, Walking aids manipulated by both arms Requirements and test methods Part 1: Walking frames DIN EN ISO 11199-2, Walking aids manipulated by both arms Requirements and test methods Part 2: Rollators DIN EN ISO

15、11334-1, Assistive products for walking manipulated by one arm Requirements and test methods Part 1: Elbow crutches DIN EN ISO 11334-4, Walking aids manipulated by one arm Requirements and test methods Part 4: Walking sticks with three or more legs EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E

16、N ISO 9999 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 f

17、r Menschen 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 nati

18、onal 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 ver

19、sion 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,

20、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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom.

21、 EUROPEAN 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 9999:20

22、16 EEuropean foreword .3Introduction 51 Scope . 62 Terms and definitions . 63 Principle 84 Elements and rules used in classification 84.1 Construction 84.2 Codes . 84.3 Titles of classes, subclasses and divisions . 94.4 Rules used in classification . 95 Index . 106 Classification . 106.1 One-level c

23、lassification Classes 106.2 Two-level classification Classes and subclasses 106.3 Three-level, detailed classification with explanations, inclusions, exclusions and references 15Annex A (informative) Membership of ISO 9999 in the WHO Family of International Classifications . 112Annex B (informative)

24、 Definition of assistive product and the standard title .113Annex C (informative) Conversion table between ISO 9999:2011 and ISO 9999:2016 114Annex D (informative) Alphabetical index 143Bibliography . 199Contents PageDIN EN ISO 9999:2017-03 EN ISO 9999:2016 (E) 2Foreword . 4European foreword This do

25、cument (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 secretariat of which is held by SIS. This European Standard shall b

26、e 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 possibility that some of the elements of this document may be

27、 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 standards organizations of the following countries are bound to im

28、plement 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, Roman

29、ia, 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. DIN EN ISO 9999:2017-03 EN ISO 9999:2016 (E)3 ForewordISO (the International Organization for Standar

30、dization) 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

31、 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

32、 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

33、 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

34、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

35、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 responsible for thi

36、s 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.DIN EN ISO 9999:2017-03 EN ISO 9999:2016 (E) 4 IntroductionAssisti

37、ve 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, inclusions, exclusions and cross-re

38、ferences 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 the classification.This edition has

39、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 in facilities such as rehabilitation c

40、entres 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 in which employment-related activiti

41、es 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 Family of International Classificati

42、onsIn 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 Standard was stimulated.This Internatio

43、nal 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 perspectives by means of two lists: a li

44、st 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-FIC (see Annex A).A major change in th

45、is 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/divisions, which take into account the g

46、iven 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 be classified as medical devices.NOT

47、E 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.DIN EN ISO 9999:2017-03 EN ISO 9999:2016 (E)5 1 ScopeThis International Standard establishes a classification and terminol

48、ogy of assistive products, especially produced or generally available, for persons with disability.Assistive products used by a person with disability, but which require 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 individually classified in this International Standard; medicines;