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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 15032:2000 ICS 11.
2、040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Prostheses Structural testing of hip joints Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the
3、Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 June 2000 BSI 06-2000 ISBN 0 580 34965 9 BS ISO 15032:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard reproduces ver
4、batim ISO 15032:2000 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/9, Orthotics and external prosthetics, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/E
5、uropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary
6、. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogu
7、e. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document compris
8、es a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 38, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:5
9、1:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 15032:2000(E) INTERNATIONAL STANDARD ISO 15032 First edition 2000-04-15 Prostheses Structural testing of hip units Prothses Essais portant sur la structure des prothses de hanche Licensed Copy: sheffieldun sheffieldun, na, Sun Nov
10、26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) ii? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) ?iii Contents?Page Foreword.iv Introduction.v 1?Scope 1 2?Normative reference1 3?Terms and definit
11、ions .1 4?Test configurations .2 4.1?General2 4.2?Axes of coordinate system.2 4.3?Reference planes.2 4.4?Reference points5 4.5?Test force5 4.6?Load line.5 4.7?Reference distances5 5?Test samples5 5.1?Types of test sample .5 5.2?Responsibilities regarding selection, preparation and alignment of test
12、samples6 5.3?Selection of test samples6 5.4?Preparation of test samples6 5.5?Alignment of test samples7 6?Test requirements and conditions.8 6.1?Types of test.8 6.2?Test loading requirements8 6.3?Requirements and conditions relevant to test procedures and equipment9 6.4?A-P and M-L test procedures12
13、 6.5?Torsional test procedures.18 6.6?Number of tests required23 6.7?Restrictions on multiple use of test samples.23 6.8?Accuracy.23 7?Test loading parameters .24 7.1?Test loads and references 24 7.2?Details of loading.25 8?Test submission document27 8.1?Document need27 8.2?General requirements27 8.
14、3?Information required for test samples.28 8.4?Information required for tests 28 9?Test report29 9.1?General requirements29 9.2?Records required for all test samples .29 9.3?Records required for all tests.30 9.4?Records required for results of A-P and M-L tests 30 9.5?Records required for results of
15、 torsional tests31 Annex A (normative) Description of internal loads and their effects32 Annex B (informative) Reference data for the specification of the A-P, M-L and torsional test loading conditions at different test loading levels.35 Bibliography38 Licensed Copy: sheffieldun sheffieldun, na, Sun
16、 Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) iv? Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out throug
17、h 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborat
18、es closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circ
19、ulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not b
20、e held responsible for identifying any or all such patent rights. International Standard ISO 15032 was prepared by Technical Committee ISO/TC 168,Prosthetics and orthotics. Annex A forms an integral part of this International Standard. Annex B is given for information only. Licensed Copy: sheffieldu
21、n sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) ?v Introduction Throughout this International Standard, the term prosthesis means an externally applied device used to replace wholly, or in part, an absent or deficient limb segment. During use a pro
22、sthesis is subject to a series of load actions each varying individually with time. The test methods specified in this International Standard use simplified static and cyclic strength tests in which antero-posterior (A-P) and medio-lateral (M-L) components of loading are produced in separate tests b
23、y the application of test forces in two different test planes. The static tests relate to the worst loads generated in any activity. The cyclic tests relate to normal walking activities where loads occur regularly with each step. This International Standard specifies fatigue testing of structural co
24、mponents. The tests specified do not provide sufficient data to predict actual service life. The evaluation of hip disarticulation prostheses and their components requires controlled field trials in addition to the laboratory tests specified in this International Standard. The laboratory tests and f
25、ield trials should be repeated when significant design changes are made to a load- bearing part of a prosthesis. Ideally, additional laboratory tests should be carried out to deal with function, wear and tear, new material developments, environmental influences, and amputee activities as part of the
26、 evaluation procedure. There are no standards for such tests, so appropriate procedures will need to be specified. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006
27、, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD?ISO 15032:2000(E) ?1 Prostheses Structural testing of hip units 1?Scope This International Standard specifies test methods for components and assemblies of hip disarticulation prostheses which are arranged at hip and thigh level. It does not apply
28、to other components of lower limb prostheses for which test methods are given in ISO 10328. This International Standard specifies procedures for simplified static and cyclic strength tests in which the antero- posterior (A-P) and medio-lateral (M-L) components of loading are produced in separate tes
29、ts by the application of test forces in two different test planes. The components of loading produced in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking. 2?Normative reference The following normative
30、 document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are
31、encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO
32、 8549-1:1989,Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses. 3?Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 8549-1 and the following apply. 3.1 brittle failure fracture of
33、any component without significant plastic deformation at the fracture 3.2 ductile failure ?.? fracture of any component with significant plastic deformation at the fracture 3.3 ductile failure ?.? gross plastic deformation of the test sample 3.4 test equipment any test machine or device adapted or s
34、pecifically designed to the test requirements of this International Standard and complying with the requirements on accuracy of 6.8 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) 2? 4?Test configurations 4.1? General 4.1.1
35、?For easeininterpretation, presentation and application ofthisInternational Standard,two test configurations are specified, one for right-sided application and a mirror image for left-sided application. This approach enables the application of uniform sign conventions for corresponding components of
36、 loading generated in the load-bearing structures of right and left prostheses or asymmetrically designed prosthetic components. 4.1.2?Each test configuration is defined in a three-dimensional, rectangular coordinate system, containing a geometric system of planes, lines and points (see Figures 1 an
37、d 2). 4.1.3?Each test configuration specifies reference parameters both for the position of the line of application of the test force and for the alignment of test samples within the coordinate system. 4.2? Axes of coordinate system 4.2.1?The axes of each of the coordinate systems have an origin at
38、ground level and are specified in 4.2.2 to 4.2.4 in relation to a prosthesis which is standing on the ground in a vertical position. If a test sample is not in a vertical position, the axes of the coordinate system shall be rotated to correspond. 4.2.2?The u?-axis is a line extending from the origin
39、 and passing through the effective knee-joint centre (see 5.5.2.2) and the effective hip-joint centre (see 5.5.2.4). Its positive direction is upwards (in the proximal direction). 4.2.3?The o?-axis is perpendicular to the u?-axis and parallel to the effective hip-joint centreline (see 5.5.2.3). Its
40、positive direction is outward (in the lateral direction), which is to the left for a left prosthesis and to the right for a right prosthesis. 4.2.4?The f ?-axis is perpendicular to both the o?-axis and the u?-axis. Its positive direction is forward towards the toe (in the anterior direction). 4.3? R
41、eference planes The reference planes (see Figure 1) shall be parallel planes perpendicular to the u?-axis of the coordinate system. 4.3.1?Bottom reference plane, BK The bottom reference plane, BK, is located at a distance u? = u?BKfrom the origin. It contains the bottom load application point PBK. 4
42、.3.2?Knee reference plane, K The knee reference plane, K, is located at a distance u? = u?Kfrom the origin. It contains the effective knee-joint centre (see 5.5.2.2). 4.3.3?Hip reference plane, H The hip reference plane, H, is located at a distance u? = u?Hfrom the origin. It contains the effective
43、hip-joint centre (see 5.5.2.4). 4.3.4?Top reference plane, TH The top reference plane, TH, is located at a distance u? = u?THfrom the origin. It contains the top load application point PTH. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO
44、 15032:2000(E) ?3 Key 1? Top reference plane, TH 2? Hip reference plane, H 3? Knee reference plane, K 4? Bottom reference plane, BK a? Right b? Left Figure 1 Coordinate system according to 4.2 with reference planes Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncon
45、trolled Copy, (c) BSI ISO 15032:2000(E) 4? ) A-P ext. test loading condition?b) A-P flex. test loading condition Key 1? Effective lever arm, LH 2? Effective hip joint centre 3? Effective knee joint centre 4? Effective lever arm 5? Effective hip joint centre line 6? Effective knee joint centre line 7
46、? Effective hip joint centre 8? Effective knee joint centre c) M-L test loading condition Figure 2 Test configurations for A-P and M-L tests in f ?-u?- and o?-u?- plane Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15032:2000(E) ?5 4.4
47、? Reference points The reference points shall be the points of intersection of the load line (see 4.6) with the reference planes. The coordinates of the reference points are as follows: bottom load application point PBK(f ?BK, o?BK, u?BK); knee load reference point PK(f ?K, o?K, u?K); hip load refer
48、ence point PH(f ?H, o?H, u?H); top load application point PTH(f ?TH, o?TH, u?TH). NOTE?In the following text the f ?- and o?-coordinates are also referred to as offsets (see also 4.7). 4.5? Test force The test force F shall be a single compressive load applied to the bottom and top load application
49、points PBKand PTH. 4.6? Load line The load line shall be the line of application of the test force F which passes through the reference points PKand PH. 4.7? Reference distances 4.7.1?Offsets The offsets shall be the perpendicular distances of the reference points (see 4.3.1 and 4.4) from the o-u-plane and the u-f-plane of the coordinate systems (see 4.1 and 4.2). They are identical with the corresponding f ?- or o?- coordinates, respectively, of these reference points. 4.7.2?Effective lever arms The effective lever arms shall be the perpendicular distances from
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