1、Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g4
2、0g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58prostheses Requirements and test methodsThe European Standard EN ISO 10328:2006 has the status of a British StandardICS 11.040.40Prosthetics Structural testing of lower-limb BRITISH STANDARDBS EN ISO 10328:2006BS EN ISO 10328:2006
3、Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHSThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006ISBN
4、0 580 48702 4-,-,-Amendments issued since publicationAmd. No. Date CommentsA list of organizations represented on CH/168 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicat
5、ion.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 10328:2006. It supersedes BS ISO 10328-1:1996, BS ISO 10328-2:1996, BS ISO 10328-3:1996, BS ISO 10328-4:1996, BS ISO
6、 10328-5:1996, BS ISO 10328-6:1996, BS ISO 10328-7:1996 and BS ISO 10328-8:1996, which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10328October 2006ICS 11.040.40Engl
7、ish VersionProsthetics - Structural testing of lower-limb prostheses -Requirements and test methods (ISO 10328:2006)Prothses - Essais portant sur la structure des prothsesde membres infrieurs - Exigences et mthodes dessai(ISO 10328:2006)Prothetik - Prfung der Struktur von Prothesen der unterenGliedm
8、aen - Anforderungen und Prfverfahren (ISO10328:2006)This European Standard was approved by CEN on 13 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alte
9、ration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by transla
10、tionunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary
11、, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue d
12、e Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10328:2006: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking p
13、ermitted without license from IHS-,-,-Foreword This document (EN ISO 10328:2006) has been prepared by Technical Committee ISO/TC 168 “Prosthetics and orthotics“ in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability“, the secretariat of which is held by
14、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 April 2007, and conflicting national standards shall be withdrawn at the latest by April 2007. This document has been prepared under a mandate
15、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 informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the
16、 national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan
17、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10328:2006 has been approved by CEN as EN ISO 10328:2006 without any modifications. EN ISO 10328:2006Copyright European Committee for Standardization Provided by IHS under lice
18、nse with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Reference numberISO 10328:2006(E)INTERNATIONAL STANDARD ISO10328First edition2006-10-01Prosthetics Structural testing of lower-limb prostheses Requirements and test methods Prothses Essais portant sur la s
19、tructure des prothses de membres infrieurs Exigences et mthodes dessai EN ISO 10328:2006Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ii Copyright European Committee for Standa
20、rdization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-iiiContents Page Foreword ix Introduction x 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Designations and symbols of test forces and moments 3 5 S
21、trength and related performance requirements and conditions of use 3 6 Coordinate systems and test configurations 5 6.1 General. 5 6.2 Axes of coordinate systems 5 6.3 Reference planes 5 6.3.1 General. 5 6.3.2 Top reference plane, T 5 6.3.3 Knee reference plane, K. 5 6.3.4 Ankle reference plane, A 5
22、 6.3.5 Bottom reference plane, B . 6 6.4 Reference points. 8 6.5 Test force. 8 6.6 Load line 8 6.7 Longitudinal axis of the foot and effective joint centres and centrelines 8 6.7.1 General. 8 6.7.2 Longitudinal axis of the foot 8 6.7.3 Effective ankle-joint centre 8 6.7.4 Effective ankle-joint centr
23、eline 10 6.7.5 Effective knee-joint centreline. 10 6.7.6 Effective knee-joint centre . 11 6.8 Reference distances. 11 6.8.1 Offsets 11 6.8.2 Combined offsets 11 6.8.3 Effective lever arms LAand LK11 6.8.4 Distance LBT11 7 Test loading conditions and test loading levels 11 7.1 Test loading conditions
24、 11 7.1.1 General. 11 7.1.2 Test loading conditions of principal structural tests 12 7.1.3 Test loading conditions of separate structural tests 12 7.2 Test loading levels 12 8 Values of test loads, dimensions and cycles 13 9 Compliance 21 9.1 General. 21 9.2 Selection of tests required to claim comp
25、liance with this International Standard 21 9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard 21 9.3.1 General. 21 9.3.2 Particular arrangements concerning the ankle-foot device or f
26、oot unit. 21 9.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot device or foot unit to the remainder of the prosthetic structure. 21 EN ISO 10328:2006Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resa
27、leNo reproduction or networking permitted without license from IHS-,-,-iv 9.4 Number of tests and test samples required to claim compliance with this International Standard. 22 9.5 Multiple use of test samples 22 9.5.1 General . 22 9.5.2 Restriction 23 9.6 Testing at particular test loading levels n
28、ot specified in this International Standard. 23 10 Test samples 25 10.1 Selection of test samples . 25 10.1.1 General . 25 10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot. 25 10.2 Types of test samples. 26 10.2.1 Complete structure . 26 10.2.2 Partial structure. 28
29、10.2.3 Any other structure. 28 10.3 Preparation of test samples. 28 10.4 Identification of test samples. 29 10.5 Alignment of test samples . 30 10.5.1 Test samples for principal tests and separate tests on knee locks 30 10.5.2 Test samples for separate tests on ankle-foot devices and foot units . 30
30、 10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts 31 10.5.4 Test samples for separate tests on knee locks . 31 10.6 Worst-case alignment position of test samples 32 11 Responsibility for test preparation . 32 12 Test submiss
31、ion document 33 12.1 General requirements . 33 12.2 Information required for test samples 34 12.2.1 All test samples. 34 12.2.2 Test samples for tests on ankle-foot devices and foot units . 34 12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints and associat
32、ed parts 34 12.3 Information required for tests 35 12.3.1 General . 35 12.3.2 For all tests 35 12.3.3 For static tests in torsion and on ankle-foot devices and foot units. 35 12.3.4 For static ultimate strength tests 35 12.3.5 For cyclic tests 35 12.3.6 For tests in torsion 35 12.3.7 For tests on an
33、kle-foot devices and foot units 36 13 Equipment 36 13.1 General . 36 13.2 Equipment for the principal tests specified in 16.2 and 16.3 . 36 13.2.1 End attachments . 36 13.2.2 Jig (optional) 38 13.2.3 Test equipment 38 13.3 Equipment for the separate static test in torsion specified in 17.1 . 40 13.3
34、.1 Test equipment 40 13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 40 13.4.1 Test equipment 40 13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3.44 13.5.1 Extensi
35、on pieces. 44 13.5.2 Test equipment to perform static compression loading (Compression testing machine or other equipment) 44 13.6 Equipment for the separate tests on knee locks specified in 17.4 44 13.6.1 End attachments . 44 13.6.2 Jig (optional) 44 13.6.3 Test equipment 44 EN ISO 10328:2006Copyri
36、ght European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-v14 Accuracy 45 14.1 General. 45 14.2 Accuracy of equipment 45 14.3 Accuracy of procedure. 45 15 Test principles. 46 15.1 General. 46 15
37、.2 Static test procedure 46 15.3 Cyclic test procedure . 46 16 Test procedures Principal structural tests . 46 16.1 Test loading requirements. 46 16.1.1 Preparation for test loading. 46 16.1.2 Application of test loading. 46 16.2 Principal static test procedure 48 16.2.1 Principal static proof test.
38、 48 16.2.2 Principal static ultimate strength test. 53 16.3 Principal cyclic test procedure 57 16.3.1 General requirements. 57 16.3.2 Test method. 57 16.3.3 Performance requirements 61 16.3.4 Compliance conditions 61 17 Test procedures Separate structural tests . 65 17.1 Separate static test in tors
39、ion . 65 17.1.1 General. 65 17.1.2 Purpose of test 65 17.1.3 Test method. 65 17.1.4 Performance requirements 67 17.1.5 Compliance conditions 67 17.2 Separate tests on ankle-foot devices and foot units 69 17.2.1 General. 69 17.2.2 Purpose of tests 69 17.2.3 Separate static proof test for ankle-foot d
40、evices and foot units . 69 17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units . 73 17.2.5 Separate cyclic test for ankle-foot devices and foot units. 78 17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts 83 17.3.1
41、 General. 83 17.3.2 Purpose of test 83 17.3.3 Applicability of the test to specific test samples 83 17.3.4 Test method. 84 17.3.5 Performance requirement 84 17.3.6 Compliance conditions 85 17.4 Separate tests on knee locks 86 17.4.1 General. 86 17.4.2 Purpose of tests 86 17.4.3 Separate static proof
42、 test for knee locks . 86 17.4.4 Separate static ultimate strength test for knee locks . 90 17.4.5 Separate cyclic test for knee locks. 92 18 Test laboratory/facility log . 101 18.1 General requirements. 101 18.2 Specific requirements 101 19 Test report . 101 19.1 General requirements. 101 19.2 Spec
43、ific requirements 102 19.3 Options 102 20 Classification and designation 102 20.1 General. 102 20.2 Examples of classification and designation 102 EN ISO 10328:2006Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permi
44、tted without license from IHS-,-,-vi 21 Labelling. 103 21.1 General . 103 21.2 Use of mark “*)“ and warning symbol. 104 21.3 Examples of label layout 104 21.4 Label placement 104 Annex A (informative) Description of internal loads and their effects 106 Annex B (informative) Reference data for the sp
45、ecification of test loading conditions and test loading levels of principal cyclic tests . 110 Annex C (informative) Guidance on the application of an alternative static ultimate strength test 114 Annex D (informative) Guidance on the application of an additional test loading level P6 115 Annex E (i
46、nformative) Summary of the records to be entered in the test laboratory/facility log. 118 Annex F (informative) Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1. 133
47、Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 135 Bibliography . 136 Figure 1 Coordinate systems for right and left-sided application 6 Figure 2 Coordinate systems according to Figure 1 with reference planes . 6 Fig
48、ure 3 Specific configuration with uB= 0, showing coordinate systems with reference planes (see Figures 1 and 2), reference lines, reference points and test force, F, for right and left-sided application. 7 Figure 4 Determination of longitudinal axis of foot (see 6.7.2), effective ankle-joint centre (see 6.7.3) and effective ankle-joint centreline (see 6.7.4) for test loading conditions I and II and of combined bottom offset SB(see 6.8.2) for test loading condition II see 7.1.2 b) 9 Figure 5 Position of effective knee-joint centreline for prosthetic knee units of different types .
