1、BS EN ISO 10328:2016Prosthetics Structural testingof lower-limb prostheses Requirements and testmethods (ISO 10328:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 10328:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementatio
2、n of EN ISO10328:2016. It supersedes BS EN ISO 10328:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/168, Prosthetics and orthotics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication
3、 does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 92522 1ICS 11.040.40Compliance with a British Standard cannot confer immunity fromleg
4、al obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10328 June 2016 ICS 11.040.40 Supersedes EN ISO 10328:200
5、6English Version Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) Prothses - Essais portant sur la structure des prothses de membres infrieurs - Exigences et mthodes dessai (ISO 10328:2016) Prothetik - Prfung der Struktur von Prothesen der un
6、teren Gliedmaen - Anforderungen und Prfverfahren (ISO 10328:2016) 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 standard wi
7、thout 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 othe
8、r 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,
9、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. EUROPEAN COMMI
10、TTEE 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 10328:2016 EBS EN ISO
11、10328:2016EN ISO 10328:2016 (E) 3 European foreword This document (EN ISO 10328:2016) 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 which is he
12、ld 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 the possibilit
13、y 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 10328:2006. This document has been prepared under a mandate given to CEN by the European C
14、ommission 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 organizati
15、ons 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
16、, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10328:2016 has been approved by CEN as EN ISO 10328:2016 without any modification. BS EN ISO 10328:2016EN ISO 10328:2016 (E) 4 Annex ZA
17、(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 standardisation request M/023 concerning the development of European standards related to medic
18、al 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
19、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
20、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 essen
21、tial 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 the European foreword,
22、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 Essential Requirements of D
23、irective 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 20 and 21 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, 8, 9, 10, 15, 16, 17
24、and 18 Only covered for mechanical strength. 13.1 5, 20, and 21.4 Essential requirement 13.1 is not fully covered here; only the aspects of classification are addressed. BS EN ISO 10328:2016EN ISO 10328:2016 (E) 5 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remar
25、ks/Notes 13.3 b) 21 Only covered for classification of the use of the device. 13.3 k) 21.2 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 European standard is mai
26、ntained 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 th
27、is standard. BS EN ISO 10328:2016ISO 10328:2016(E)Foreword viiIntroduction viii1 Scope . 12 Normative references 13 Terms and definitions . 24 Designations and symbols of test forces and moments . 25 Strength and related performance requirements and conditions of use 36 Coordinate systems and test c
28、onfigurations . 56.1 General . 56.2 Axes of coordinate systems 56.3 Reference planes . 56.3.1 General 56.3.2 Top reference plane, T . 56.3.3 Knee reference plane, K . 56.3.4 Ankle reference plane, A . 66.3.5 Bottom reference plane, B . 66.4 Reference points 76.5 Test force 86.6 Load line . 86.7 Long
29、itudinal axis of the foot and effective joint centres and centrelines . 86.7.1 General 86.7.2 Longitudinal axis of the foot 86.7.3 Effective ankle-joint centre . 86.7.4 Effective ankle-joint centreline 106.7.5 Effective knee-joint centreline 106.7.6 Effective knee-joint centre 116.8 Reference distan
30、ces . 116.8.1 Offsets . 116.8.2 Combined offsets 116.8.3 Effective lever arms LAand LK.116.8.4 Distance LBT.117 Test loading conditions and test loading levels .117.1 Test loading conditions . 117.1.1 General. 117.1.2 Test loading conditions of principal structural tests .127.1.3 Test loading condit
31、ions of separate structural tests 127.2 Test loading levels . 128 Values of test loads, dimensions and cycles 139 Compliance 209.1 General 209.2 Selection of tests required to claim compliance with this International Standard .219.3 Arrangements for tests on samples of prosthetic structures includin
32、g ankle-foot devices or foot units, required to claim compliance with this International Standard .219.3.1 General. 219.3.2 Particular arrangements concerning the ankle-foot device or foot unit 219.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot de
33、vice or foot unit to the remainder of the prosthetic structure .219.4 Number of tests and test samples required to claim compliance with this International Standard 229.5 Multiple use of test samples . 22 ISO 2016 All rights reserved iiiContents PageBS EN ISO 10328:2016ISO 10328:2016(E)9.5.1 General
34、. 229.5.2 Restriction 229.6 Testing at particular test loading levels not specified in this International Standard .2310 Test samples .2510.1 Selection of test samples . 2510.1.1 General. 2510.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot 2610.2 Types of test samples
35、 . 2710.2.1 Complete structure .2710.2.2 Partial structure 2910.2.3 Any other structure 2910.3 Preparation of test samples 2910.4 Identification of test samples 3010.5 Alignment of test samples 3110.5.1 Test samples for principal tests and separate tests on knee locks 3110.5.2 Test samples for separ
36、ate tests on ankle-foot devices and foot units .3110.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts 3110.5.4 Test samples for separate tests on knee locks .3210.6 Worst-case alignment position of test samples . 3211 Responsib
37、ility for test preparation 3312 Test submission document .3412.1 General requirements 3412.2 Information required for test samples 3512.2.1 All test samples 3512.2.2 Test samples for tests on ankle-foot devices and foot units 3512.2.3 Test samples for static ultimate strength tests in maximum knee f
38、lexion for knee joints and associated parts 3512.3 Information required for tests 3512.3.1 General. 3512.3.2 For all tests . 3512.3.3 For static tests in torsion and on ankle-foot devices and foot units .3612.3.4 For static ultimate strength tests 3612.3.5 For cyclic tests .3612.3.6 For tests in tor
39、sion 3612.3.7 For tests on ankle-foot devices and foot units .3613 Equipment 3713.1 General 3713.2 Equipment for the principal tests specified in 16.2 and 16.3 3713.2.1 End attachments .3713.2.2 Jig (optional) .3913.2.3 Test equipment .4013.3 Equipment for the separate static test in torsion specifi
40、ed in 17.1 4213.3.1 Test equipment .4213.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 4213.4.1 Test equipment .4213.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3 .
41、4613.5.1 Extension pieces 4613.5.2 Test equipment to perform static compression loading (Compression testing machine or other equipment).4613.6 Equipment for the separate tests on knee locks specified in 17.4 4613.6.1 End attachments .4613.6.2 Jig (optional) .4613.6.3 Test equipment .4614 Accuracy .
42、47iv ISO 2016 All rights reservedBS EN ISO 10328:2016ISO 10328:2016(E)14.1 General 4714.2 Accuracy of equipment . 4714.3 Accuracy of procedure . 4715 Test principles 4815.1 General 4815.2 Static test procedure . 4815.3 Cyclic test procedure . 4816 Test procedures Principal structural tests.4816.1 Te
43、st loading requirements . 4816.1.1 Preparation for test loading 4816.1.2 Application of test loading 4816.2 Principal static test procedure . 5016.2.1 Principal static proof test 5016.2.2 Principal static ultimate strength test 5516.3 Principal cyclic test procedure . 5916.3.1 General requirements .
44、5916.3.2 Test method . 5916.3.3 Performance requirements 6316.3.4 Compliance conditions 6417 Test procedures Separate structural tests .6817.1 Separate static test in torsion 6817.1.1 General. 6817.1.2 Purpose of test 6817.1.3 Test method . 6817.1.4 Performance requirements 7017.1.5 Compliance condi
45、tions 7017.2 Separate tests on ankle-foot devices and foot units 7217.2.1 General. 7217.2.2 Purpose of tests7217.2.3 Separate static proof test for ankle-foot devices and foot units 7217.2.4 Separate static ultimate strength test for ankle-foot devices and foot units 7617.2.5 Separate cyclic test fo
46、r ankle-foot devices and foot units .8117.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts. 8617.3.1 General. 8617.3.2 Purpose of test 8617.3.3 Applicability of the test to specific test samples .8617.3.4 Test method . 8717.3.5 Performance require
47、ment 8817.3.6 Compliance conditions 8817.4 Separate tests on knee locks 8917.4.1 General. 8917.4.2 Purpose of tests9017.4.3 Separate static proof test for knee locks 9017.4.4 Separate static ultimate strength test for knee locks 9417.4.5 Separate cyclic test for knee locks . 9618 Test laboratory/fac
48、ility log . 10518.1 General requirements .10518.2 Specific requirements .10519 Test report 10519.1 General requirements .10519.2 Specific requirements .10619.3 Options .10620 Classification and designation 10620.1 General .106 ISO 2016 All rights reserved vBS EN ISO 10328:2016ISO 10328:2016(E)20.2 E
49、xamples of classification and designation 10621 Labelling . 10721.1 General .10721.2 Use of mark “*)” and warning symbol .10821.3 Examples of label layout .10821.4 Label placement .108Annex A (informative) Description of internal loads and their effects . 110Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests 114Annex C (informative) Guidance on the application of an alternative static ultimate strength test . 118Annex D (normative) Guidance on the a
