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1、BRITISH STANDARD BS EN ISO 22523:2006 External limb prostheses and external orthoses Requirements and test methods The European Standard EN ISO 22523:2006 has the status of a British Standard ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled
2、 Copy, (c) BSI BS EN ISO 22523:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006 ISBN 0 580 49413 6 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 22523:2006. It
3、 supersedes BS EN 12523:1999 which is withdrawn. The UK participation in its preparation 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. This publication does not purport to include all
4、 the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+
5、00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22523 October 2006 ICS 11.040.40 English Version External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) Prothses de membre externes et orthses externes - Exigences
6、 et mthodes dessai (ISO 22523:2006) Externe Gliedmaenprothesen und externe Orthesen - Anforderungen und Prfverfahren (ISO 22523:2006) 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
7、for giving this European Standard the status of a national standard 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 offici
8、al versions (English, French, German). A version in any other language 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, Be
9、lgium, Cyprus, Czech Republic, 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDAR
10、DIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 22523:2006: E Licensed Copy: sheffieldun sheffiel
11、dun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 22523:2006) 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“, th
12、e 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 withdrawn at the latest by April 2007. This document
13、has been prepared under a mandate 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
14、/CENELEC Internal Regulations, the 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,
15、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22523:2006 has been approved by CEN as EN ISO 22523:2006 without any modifications. EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun,
16、na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 22523:2006(E) INTERNATIONAL STANDARD ISO 22523 First edition 2006-10-01 External limb prostheses and external orthoses Requirements and test methods Prothses de membre externes et orthses externes Exigences et mt
17、hodes dessai EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword vi Introduction vii 1 Sco
18、pe . 1 2 Normative references. 1 3 Terms and definitions. 2 4 General requirements. 4 4.1 Risk management. 4 4.2 Intended performance and technical documentation. 5 4.3 Clinical evaluation 5 4.4 Strength and related conditions of use 5 5 Requirements for materials . 6 5.1 Flammability of materials a
19、nd toxicity of combustion products. 6 5.2 Biocompatibility, contaminants and residues. 7 5.2.1 General. 7 5.2.2 Contaminants and residues. 7 5.3 Infection and microbiological contamination 7 5.4 Resistance to corrosion and degradation 7 6 Noise and vibration. 7 7 Electromagnetic compatibility (EMC).
20、 8 8 Electrical safety. 8 8.1 Battery-powered prosthetic and orthotic devices. 8 8.1.1 Battery housings and connections. 8 8.1.2 Charge level indicators 8 8.2 Circuit protection 9 8.3 Electronic programmable systems. 9 8.4 Electrically heated blankets, pads and similar flexible heating appliances. 9
21、 8.5 Prosthetic and orthotic devices with skin contact electrodes 9 8.6 Prosthetic and orthotic devices with radio equipment. 9 8.6.1 General. 9 8.6.2 Frequency spectrum of radio equipment. 9 8.6.3 Operation of radio equipment by the user. 9 9 Surface temperature. 10 10 Sterility. 10 11 Design requi
22、rements 10 11.1 Safety of moving parts. 10 11.2 Safety of connections. 10 12 Mechanical requirements. 10 12.1 Restrictions on use. 10 12.2 Forces in soft tissues of the human body . 11 12.3 Ergonomic principles. 11 13 Information supplied by the manufacturer 11 13.1 General. 11 13.2 Labelling 12 13.
23、3 Intended use 12 14 Packaging 12 EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic devices.13 Annex B (normative) Method of de
24、termining the mechanical properties of knee joint assemblies for lower-limb orthotic devices28 Annex C (informative) Guidance on methods of determining the flammability and toxicity of combustion products of lower-limb prosthetic devices.41 Annex D (informative) Guidance on methods of establishing t
25、he force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices55 Annex E (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142 .80 Bibliography .82 Figure A.1 Test sample segmen
26、t lengths .15 Figure A.2 Configuration of test 1 .16 Figure A.3 Configuration of test 2 and test 417 Figure A.4 Configuration of test 3 and test 517 Figure A.5 Examples of test sample configurations18 Figure B.1 Example of a test rig design suitable for the application of the four-point loading syst
27、em34 Figure B.2 Arrangements of the four-point loading system (continued on Figure B.3) 35 Figure B.3 Arrangements of the four-point loading system (continued from Figure B.2).36 Figure B.4 Test orientations for joint assemblies intended to restrain motion in four directions mutually at right angles
28、 (see B.5.1).37 Figure B.5 Example of a bending moment/angular deflection curve: single-stage failure (see 3.17, 3.18 and 3.19) .38 Figure B.6 Examples of a bending moment/angular deflection curve: two-stage failures (see 3.17, 3.18 and 3.19) .39 Figure C.1 Test sample dimensions trans-femoral (abov
29、e-knee) Finished limb48 Figure C.2 Test sample dimensions trans-tibial (below-knee) Finished limb 49 Figure C.3 Test sample dimensions trans-femoral (above-knee) Socket former.50 Figure C.4 Test sample dimensions trans-tibial (below-knee) Socket former .50 Figure C.5 Radiant heat source test51 Figur
30、e C.6 Flaming ignition source test52 Figure C.7 Sample support frame and weighing platform 53 Figure D.1 Bowden cable arrangement during test.69 Figure D.2 Test set-up according to D.6.2 for sample category D.3.1 a) Orthotic knee joints with locking mechanism.70 Figure D.3 Test set-up according to D
31、.6.3 for sample category D.3.1 b) Orthotic elbow joints with locking mechanism.70 Figure D.4 Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with locking mechanism (continued on Figure D.5)71 Figure D.5 Test set-up according to D.6.4 for sample category D.3.1 c) Pro
32、sthetic knee units with locking mechanism (continued from Figure D.4)72 EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Figure D.6 Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units with lo
33、cking mechanism 72 Figure D.7 Test set-up according to D.6.6 for sample category D.3.1 e) Prosthetic elbow units with user-driven articulation 73 Figure D.8 Test set-up according to D.6.7 for sample category D.3.1 f) Terminal devices with built-in closing function. 74 Figure D.9 Test set-up accordin
34、g to D.6.8 for sample category D.3.1 g) Terminal devices with built-in opening function 75 Figure D.10 Test set-up according to D.6.9 for sample category D.3.1 h) Terminal devices with no built-in closing or opening function, actuated by force application 76 Figure D.11 Test set-up according to D.6.
35、10 for sample category D.3.1 i) Terminal devices with no built-in closing or opening function, actuated by torque application . 77 Figure D.12 Test set-up according to D.6.11 for sample category D.3.1 j) Terminal devices with break-open feature for emergency situations . 78 Figure D.13 Test set-up a
36、ccording to D.6.12 for sample category D.3.1 k) Prosthetic devices with fail-safe release unit, illustrated for a separable prosthetic adaptor plate. 79 Table A.1 Number of tests and test samples required 19 Table B.1 Example of test report. 40 Table C.1 Worked example of calculating the TTPD . 54 T
37、able D.1 Parameters of the test set-up for sample category D.3.1 a) 60 Table D.2 Parameters of the test set-up for sample category D.3.1 c) 62 Table D.3 Details of the test report 67 Table D.4 Values of actuating/operating force (and displacement) and moment measured on different categories of test
38、sample. 68 Table E.1 Correspondence between this International Standard and the essential principles of ISO/TR 16142. 81 EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vi Foreword ISO (the International Organization for St
39、andardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the rig
40、ht to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International
41、 Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as a
42、n 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO
43、22523 was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics. EN ISO 22523:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vii Introduction This International Standard has been prepared in close collaboration with Tec
44、hnical Committee CEN/TC 293 Technical aids for disabled persons. This International Standard represents the revised version of the Harmonized European Standard EN 12523:1999 already implemented by the member countries of the European Union and the European Free Trade Association in accordance with t
45、he CEN/CENELEC Internal Regulations. Consequently, these regulations apply accordingly. This International Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relations
46、hip with EU Directive(s), see informative Annex ZA, which is an integral part of this International Standard. This International Standard provides one means to demonstrate that external limb prostheses and external orthoses, which are also medical devices, conform to the essential requirements outli
47、ned in general terms in Annex 1 of the EU Directive 93/42/EEC on medical devices. This International Standard also provides means to demonstrate that external limb prostheses and external orthoses with radio equipment according to definition 3.8 conform to the essential requirements of the EU Direct
48、ive 99/5/EC on radio equipment and telecommunications terminal equipment. This standard is not intended to provide a means of showing conformity with the requirements of any other directive. There are three levels of European Standard dealing with technical aids for disabled persons. These are as fo
49、llows, with level 1 being the highest: Level 1: General requirements for technical aids Level 2: Particular requirements for families of technical aids Level 3: Specific requirements for types of technical aids. Where standards for particular aids or groups of aids exist (level 2 or 3), the requirements of lower-level standards take precedence over higher-level standards. Therefore, to address all requirements f