1、BS EN ISO 22675:2016Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods (ISO 22675:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 22675:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementa
2、tion of EN ISO 22675:2016. It supersedes BS EN ISO 22675:2006 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.A list of organizations represented on this committee can be obtained on request to its secretary.This public
3、ation 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 92520 7 ICS 11.040.40 Compliance with a British Standard cannot confer immunit
4、y from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 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 22675 June 2016 ICS 11.04
5、0.40 Supersedes EN ISO 22675:2006English Version Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) Prothses - Essais darticulations cheville-pied et units de pied - Exigences et mthodes dessai (ISO 22675:2016) Prothetik - Prfung von Knchel-Fu
6、-Passteilen und Fueinheiten - Anforderungen und Prfverfahren (ISO 22675:2016) This European Standard was approved by CEN on 12 May 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
7、 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
8、 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, Czec
9、h 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 and United Kingdom. EU
10、ROPEAN 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 22675:2016
11、 EBS EN ISO 22675:2016EN ISO 22675:2016 (E) 3 European foreword This document (EN ISO 22675:2016) has been prepared by Technical Committee ISO/TC 168 “ Prosthetics and orthoticsa“ in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” the secretariat of
12、 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 December 2016, and conflicting national standards shall be withdrawn at the latest by December 2016. Attention is drawn to th
13、e 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 22675:2006. This document has been prepared under a mandate given to CEN by th
14、e 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, B, C or D, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the nation
15、al 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, Lithu
16、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22675:2016 has been approved by CEN as EN ISO 22675:2016 without any modification. BS EN ISO 22675:2016EN ISO 226
17、75:2016 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions standardization request M/023 concerning the development of European sta
18、ndards 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
19、 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
20、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
21、the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk has to 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
22、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 Esse
23、ntial Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 9.1 5 With respect to use in combination with other devices or equipment. 9.1 19 and 20 With respect to any restrictions on use which shall be indicated on the label or in the instructions for use. 12.7.1 5, 7
24、, 8, 9, 10, 15, 16 and 17 Only covered for mechanical strength. 13.1 5, 19, and 20.4 Essential requirement 13.1 is not fully covered here; only the aspects of classification are addressed. BS EN ISO 22675:2016EN ISO 22675:2016 (E) 5 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(
25、s) of this EN Remarks/Notes 13.3 b) 20 Only covered for classification of the use of the device. 13.3 k) 20.2 Only covered for limitations due to body mass limit and specific activities undertaken by the user. WARNING 1: Presumption of conformity stays valid only as long as a reference to this Europ
26、ean 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 wit
27、hin the scope of this standard. BS EN ISO 22675:2016ISO 22675:2016(E)Foreword viIntroduction vii1 Scope . 12 Normative references 13 Terms and definitions . 24 Designations and symbols of test forces 25 Strength and related performance requirements and conditions of use 36 Coordinate system and test
28、 configurations 46.1 General . 46.2 Origin and axes of the coordinate system 46.3 Reference points 56.4 Test force F .66.5 Line of application of test force F .66.6 Lines of action of resultant reference forces FR1and FR2.66.7 Longitudinal axis of the foot and effective ankle joint centre. 66.7.1 Ge
29、neral 66.7.2 Longitudinal axis of the foot 66.7.3 Effective ankle-joint centre, CA.77 Test loading conditions and test loading levels 87.1 Test loading conditions 87.2 Test loading levels 88 Values of test forces, dimensions and cycles . 99 Compliance 169.1 General 169.2 Particular arrangements and
30、requirements concerning the part required to connect an ankle-foot device or foot unit to the remainder of a prosthetic structure .179.2.1 Arrangements for testing 179.2.2 Requirements for claiming compliance 179.3 Number of tests and test samples required to claim compliance with this International
31、 Standard 179.4 Multiple use of test samples . 189.4.1 General. 189.4.2 Restriction 189.5 Testing at particular test loading levels not specified in this International Standard .1810 Test samples .1910.1 Selection of test samples . 1910.1.1 General. 1910.1.2 Selection of ankle-foot devices and foot
32、units of appropriate size of foot 1910.2 Types of test sample 2010.2.1 Complete structure .2010.2.2 Partial structure 2010.3 Preparation of test samples 2010.4 Identification of test samples 2110.5 Alignment of test samples 2110.6 Worst-case alignment position of test samples . 2111 Responsibility f
33、or test preparation 2312 Test submission document .2412.1 General requirements 2412.2 Information required for test samples 24 ISO 2016 All rights reserved iiiContents PageBS EN ISO 22675:2016ISO 22675:2016(E)12.3 Information required for tests 2512.3.1 General. 2512.3.2 For all tests . 2512.3.3 For
34、 the static proof test and the static ultimate strength test .2512.3.4 For the static ultimate strength test .2512.3.5 For the cyclic test 2513 Equipment 2613.1 General 2613.2 End attachments . 2613.2.1 General. 2613.2.2 Proof test of end attachments 2613.3 Jig (optional) 2813.4 Test equipment 2913.
35、4.1 Test equipment to perform static heel and forefoot loading 2913.4.2 Test equipment to perform cyclic loading 3014 Accuracy .3714.1 General 3714.2 Accuracy of equipment . 3714.3 Accuracy of procedure . 3715 Test principles 3815.1 General 3815.2 Static test procedure . 3915.3 Cyclic test procedure
36、 . 3916 Test procedures 3916.1 Test loading requirements . 3916.1.1 Preparation for test loading 3916.1.2 Test loading conditions .4316.2 Static proof test 4316.2.1 Test method . 4316.2.2 Performance requirement 4516.2.3 Compliance conditions 4516.3 Static ultimate strength test . 4716.3.1 Test meth
37、od . 4716.3.2 Performance requirements 5016.3.3 Compliance conditions 5016.4 Cyclic test 5116.4.1 Test method . 5116.4.2 Performance requirements 5416.4.3 Compliance conditions 5517 Test laboratory/facility log .5717.1 General requirements 5717.2 Specific requirements 5718 Test report 5718.1 General
38、 requirements 5718.2 Specific requirements 5818.3 Options 5819 Classification and designation 5819.1 General 5819.2 Examples of classification and designation . 5820 Labelling .5920.1 General 5920.2 Use of mark “*)” and warning symbol 6020.3 Examples of label layout 6020.4 Label placement 61iv ISO 2
39、016 All rights reservedBS EN ISO 22675:2016ISO 22675:2016(E)Annex A (informative) Reference data for the specification of the test loading conditions and test loading levels of this International Standard .62Annex B (informative) Guidance on the application of an alternative static ultimate strength
40、 test .70Annex C (normative) Application of an additional test loading level P6, P7, and P8 71Annex D (informative) Summary of the records to be entered in the test laboratory/facility log 73Annex E (informative) Information on Technical Report ISO/TR 22676179Annex F (informative) Reference to the e
41、ssential principles of safety and performance of medical devices according to ISO/TR 16142 .90Bibliography .91 ISO 2016 All rights reserved vBS EN ISO 22675:2016ISO 22675:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (I
42、SO 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, gov
43、ernmental 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 mainte
44、nance 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).Attent
45、ion 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
46、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
47、 assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 168, Prosthetics and orthotics.This second edition cancels and repl
48、aces the first edition ISO 22675:2006 which has been technically revised with the following changes:a) Test loading levels P7 and P8 have been introduced in Table 10, Table A.1, Table C.1, Table C.2 and the clauses pointing at these tables have been updated. Additional information on P7 and P8 is gi
49、ven in Annex A.1;b) Table 9 has been revisedc) Annex C has changed from informative to normativevi ISO 2016 All rights reservedBS EN ISO 22675:2016ISO 22675:2016(E)IntroductionThis International Standard offers alternatives to the structural tests on ankle-foot devices and foot units specified in 17.2 of ISO 10328:2016, which still suffer from several “weaknesses”, such as:a) the inconsistency of the lines of application of the heel and forefoot test forces with those of the test forces of test loading conditions I and II for t
