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1、BRITISH STANDARD BS EN ISO 22675:2006 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods The European Standard EN ISO 22675:2006 has the status of a British Standard ICS 11.040.40 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec
2、 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 22675:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 December 2006 BSI 2006 ISBN 0 580 48654 0 National foreword This British Standard was published by BSI. It is the
3、UK implementation of EN ISO 22675:2006. EN ISO 22675:2006 is a candidate “harmonized” European Standard and fully takes into account the requirements given under the EU Medical Devices Directive (93/42/EEC), and intended to lead to CE marking. The date of applicability of EN ISO 22675:2006 as a “har
4、monized” European Standard, i.e. the date after which this standard may be used for CE marking purposes, is subject to an announcement in the Official Journal of the European Communities. The Commission in consultation with Member States has agreed a transition period for the co-existence of harmoni
5、zed European Standards and their corresponding national standard(s). It is intended that this period will comprise a period, usually nine months, after the date of availability of the European Standard, during which any required changes to national regulations are to be made, followed by a further p
6、eriod, usually of 12 months, for the implementation of CE marking. At the end of this co-existence period, the national standard(s) will be withdrawn. EN ISO 22675:2006 is the subject of transitional arrangements agreed under the European Commission mandate. In the UK, there are no corresponding nat
7、ional standards. The UK participation in the preparation of EN ISO 22675:2006 was entrusted to Technical Committee CH/168, Prosthetics and orthotics. A list of organizations represented on CH/168 can be obtained on request to its secretary. Additional information ISO 10328:2006 supersedes BS ISO 103
8、28:1996. The test methods and performance requirements for ankle-foot devices in ISO 10328:2006 have been validated by extensive records of test data and field monitoring of performance of many designs of prosthetic feet and ankle-foot devices in service internationally. EN ISO 22675:2006 specifies
9、methods of mechanical testing of prosthetic feet and ankle-foot devices. In the period preceding the publication of EN ISO 22675:2006, tests were conducted, using the methods specified in this standard, on eight prostheses from different manufacturers, which had previously shown satisfactory perform
10、ance in the international field and which had satisfied the test requirements of ISO 10328:2006. Of the eight samples, four satisfied the requirements of EN ISO 22675:2006 but four did not. These latter four examples utilized ankle-foot devices that have been in the field for over 25 years, with les
11、s than 1 per cent being the subject of an adverse report. In the opinion of BSI Technical Committee CH/168 there is a need to validate EN ISO 22675:2006 prior to superseding ISO 10328:2006 as an applicable standard for the mechanical testing for safety of any ankle-foot devices that are placed in th
12、e field. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 22675:2006 i This information should be borne in mind when decisions are made on whet
13、her mechanical tests on prosthetic feet or ankle-foot devices should be in accordance with the requirements of ISO 10328 or of EN ISO 22675:2006. Such tests are generally required to demonstrate compliance with the Essential Requirements for Medical Devices defined in the European Medical Device Dir
14、ective No. 93/42/EEC:1998. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed Copy: London South Bank University, London
15、 South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22675 Octobe
16、r 2006 ICS 11.040.40 English Version Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006) Prothses - Essais darticulations cheville-pied et units de pied - Exigences et mthodes dessai (ISO 22675:2006) Prothetik - Prfung von Knchel-Fu-Passteilen
17、und Fueinheiten - Anforderungen und Prfverfahren (ISO 22675:2006) 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 European Standard the status of a national standard
18、without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 langua
19、ge made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Ge
20、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMU
21、NG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22675:2006: E Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:0
22、0 2006, Uncontrolled Copy, (c) BSI Foreword latest by April 2007. This document has been prepared under a mandate given to CEN by the European Commission and the For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC
23、Internal Regulations, the national standards organizations of the following Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and U
24、nited Kingdom. Endorsement notice The text of ISO 22675:2006 has been approved by CEN as EN ISO 22675:2006 without any modifications. This document (EN ISO 22675:2006) has been prepared by Technical Committee ISO/TC 168 “Prosthetics and orthotics“ in collaboration with Technical Committee CEN/TC 293
25、 “Assistive products for persons with disability“, the secretariat of 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 April 2007, and conflicting national standards shall be
26、withdrawn at the European Free Trade Association, and supports essential requirements of EU Directive(s). countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, EN ISO 22675:2006 Licensed Copy: London South Bank University, London South Bank University, Su
27、n Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 22675:2006(E) INTERNATIONAL STANDARD ISO 22675 First edition 2006-10-01 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods Prothses Essais darticulations cheville-pied et units de pi
28、ed Exigences et mthodes dessai EN ISO 22675:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006,
29、 Uncontrolled Copy, (c) BSI iii Contents Page Foreword. vii Introduction. viii 1 Scope . 1 2 Normative references. 2 3 Terms and definitions. 2 4 Designations and symbols of test forces 2 5 Strength and related performance requirements and conditions of use 3 6 Coordinate system and test configurati
30、ons 4 6.1 General. 4 6.2 Origin and axes of the coordinate system. 4 6.3 Reference points. 5 6.4 Test force F 6 6.5 Line of application of test force F . 6 6.6 Lines of action of resultant reference forces FR1 and FR2. 6 6.7 Longitudinal axis of the foot and effective ankle joint centre 6 6.7.1 Gene
31、ral. 6 6.7.2 Longitudinal axis of the foot 6 6.7.3 Effective ankle-joint centre, CA 7 7 Test loading conditions and test loading levels 8 7.1 Test loading conditions 8 7.2 Test loading levels 8 8 Values of test forces, dimensions and cycles. 9 9 Compliance 16 9.1 General. 16 9.2 Particular arrangeme
32、nts and requirements concerning the part required to connect an ankle-foot device or foot unit to the remainder of a prosthetic structure 17 9.2.1 Arrangements for testing. 17 9.2.2 Requirements for claiming compliance 17 9.3 Number of tests and test samples required to claim compliance with this In
33、ternational Standard 17 9.4 Multiple use of test samples 18 9.4.1 General. 18 9.4.2 Restriction . 18 9.5 Testing at particular test loading levels not specified in this International Standard. 18 10 Test samples . 19 10.1 Selection of test samples. 19 10.1.1 General. 19 10.1.2 Selection of ankle-foo
34、t devices and foot units of appropriate size of foot. 19 10.2 Types of test sample 20 10.2.1 Complete structure. 20 10.2.2 Partial structure 20 10.3 Preparation of test samples. 20 10.4 Identification of test samples 21 10.5 Alignment of test samples. 21 10.6 Worst-case alignment position of test sa
35、mples 21 11 Responsibility for test preparation. 23 12 Test submission document . 24 12.1 General requirements. 24 12.2 Information required for test samples 24 12.3 Information required for tests . 25 12.3.1 General. 25 12.3.2 For all tests 25 12.3.3 For the static proof test and the static ultimat
36、e strength test . 25 EN ISO 22675:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv 12.3.4 For the static ultimate strength test25 12.3.5 For the cyclic test25 13 Equipment26 13.1 General.26 13.2 End atta
37、chments .26 13.2.1 General.26 13.2.2 Proof test of end attachments .26 13.3 Jig (optional)28 13.4 Test equipment28 13.4.1 Test equipment to perform static heel and forefoot loading28 13.4.2 Test equipment to perform cyclic loading30 14 Accuracy37 14.1 General.37 14.2 Accuracy of equipment 37 14.3 Ac
38、curacy of procedure.38 15 Test principles.38 15.1 General.38 15.2 Static test procedure 39 15.3 Cyclic test procedure39 16 Test procedures 39 16.1 Test loading requirements.39 16.1.1 Preparation for test loading.39 16.1.2 Test loading conditions43 16.2 Static proof test.43 16.2.1 Test method.43 16.2
39、.2 Performance requirement 45 16.2.3 Compliance conditions.45 16.3 Static ultimate strength test.47 16.3.1 Test method.47 16.3.2 Performance requirements 50 16.3.3 Compliance conditions.50 16.4 Cyclic test 52 16.4.1 Test method.52 16.4.2 Performance requirements 54 16.4.3 Compliance conditions.55 17
40、 Test laboratory/facility log .58 17.1 General requirements.58 17.2 Specific requirements.58 18 Test report58 18.1 General requirements.58 18.2 Specific requirements.59 18.3 Options.59 19 Classification and designation59 19.1 General.59 19.2 Examples of classification and designation 59 20 Labelling
41、.60 20.1 General.60 20.2 Use of mark “*)“ and warning symbol.61 20.3 Examples of label layout61 20.4 Label placement62 Annex A (informative) Reference data for the specification of the test loading conditions and test loading levels of this International Standard.63 Annex B (informative) Guidance on
42、 the application of an alternative static ultimate strength test71 Annex C (informative) Guidance on the application of an additional test loading level P672 Annex D (informative) Summary of the records to be entered in the test laboratory/facility log 74 Annex E (informative) Information on Technic
43、al Report ISO/TR 22676 180 Annex F (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 91 Bibliography .92 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Direc
44、tives .93 EN ISO 22675:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:02:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Figure 1 Coordinate system with reference parameters. 5 Figure 2 Determination of longitudinal axis of foot (see 6.7.2) and effectiv
45、e ankle-joint centre CA (see 6.7.3) 7 Figure 3 Illustration of reference points for the establishment of thresholds listed in Table 10 for specification of the loading profile of the cyclic test 14 Figure 4 Illustration of specific set-up of left-sided test sample with top load application point PT
46、23 Figure 5 Diagrammatic view of test equipment according to 13.4.1 and 13.4.2 with test sample 35 Figure 6 Profiles of test force Fc(t) and tilting angle (t) as synchronized functions of time, determining the loading condition of the cyclic test of this International Standard. 36 Figure 7 Test forc
47、e Fc() of test loading level P5 as function of tilting angle (t) of foot platform 37 Figure 8 Preparation for test loading of static test procedure see 16.1.1 a) 42 Figure 9 Flowchart for the static proof test specified in 16.2.1 46 Figure 10 Flowchart for the static ultimate strength test specified
48、 in 16.3.1 51 Figure 11 Flowchart for the cyclic test specified in 16.4.1 Continued on Figure 12. 56 Figure 12 Flowchart for the cyclic test specified in 16.4.1 Continued from Figure 11 . 57 Figure 13 General concept for the label layout 60 Figure 14 Models for the label layout 61 Figure A.1 Illustr
49、ation of different components of loading. 69 Figure A.2 Illustration of the dependence of the position of the top load application point PT on the foot length L (see A.2.2.3) 70 Figure E.1 Effect of f-position of tilting axis TA of foot platform on the elevation E of the foot at the instants of heel contact and toe-off 83 Figure E.2 Effect of u-position of tilting axis TA of foot platform on the A/P displacement f of the foot at the instant