ISO-22675-2006.pdf
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1、 Reference number ISO 22675:2006(E) ISO 2006 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 pied Exigences et mthodes dessai Copyright Internatio
2、nal Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/04/2007 00:04:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22675:2006(E) PDF disclaimer This PDF file may contain em
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5、s were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise sp
6、ecified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office
7、 Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111
8、111001, User=Wing, Bernie Not for Resale, 04/04/2007 00:04:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22675:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword. vii Introduction. viii 1 Scope . 1 2 Normative references. 2 3 Terms and definitions. 2 4
9、 Designations and symbols of test forces 2 5 Strength and related performance requirements and conditions of use 3 6 Coordinate system and test configurations 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 f
10、orce 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 General. 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 Tes
11、t 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 arrangements 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.
12、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 International 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 level
13、s 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-foot 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 1
14、0.3 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 samples 21 11 Responsibility for test preparation. 23 12 Test submission document . 24 12.1 General requirements. 24 12.2 Information required for
15、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 ultimate strength test . 25 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/11111
16、11001, User=Wing, Bernie Not for Resale, 04/04/2007 00:04:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22675:2006(E) iv ISO 2006 All rights reserved 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
17、 attachments .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
18、.3 Accuracy 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
19、 16.2.2 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.
20、55 17 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 Labe
21、lling.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) Guidan
22、ce on 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 Te
23、chnical 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 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employee
24、s/1111111001, User=Wing, Bernie Not for Resale, 04/04/2007 00:04:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22675:2006(E) ISO 2006 All rights reserved v Figure 1 Coordinate system with reference parameters. 5 Figure 2 Determination of longitudinal axis of foot (
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