EN ISO 22523-2006 en External limb prostheses and external orthoses - Requirements and test methods《外肢假体和矫形外支架 要求和试验方法 ISO 22523-2006》.pdf

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1、BRITISH STANDARDBS EN ISO 22523:2006External limb prostheses and external orthoses Requirements and test methodsThe European Standard EN ISO 22523:2006 has the status of a British StandardICS 11.040.40g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g4

2、0g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 22523:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006ISBN 0 580 49413 6National forewordThis British S

3、tandard was published by BSI. It is the UK implementation of EN ISO 22523:2006. It supersedes BS EN 12523:1999 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.A list of organizations represented on CH/168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 obtain

4、ed 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 application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date

5、CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22523October 2006ICS 11.040.40English VersionExternal limb prostheses and external orthoses - Requirementsand test methods (ISO 22523:2006)Prothses de membre externes et orthses externes -Exigences et mthodes dessai (ISO 22523:2006)Extern

6、e 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 for giving this EuropeanStandard the status o

7、f a national standard without any alteration. 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

8、 in any other language made by translationunder 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, Fi

9、nland, 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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMI

10、TEE FR NORMUNGManagement Centre: rue de 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 22523:2006: EForeword This document (EN ISO 22523:2006) has been prepared by Technical Committee ISO/TC 168

11、 “Prosthetics and orthotics“ in collaboration with Technical Committee CEN/TC 293 “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 endor

12、sement, 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 given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive

13、(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 national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus

14、, 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. Endorsement notice The text of ISO 22523:20

15、06 has been approved by CEN as EN ISO 22523:2006 without any modifications. EN ISO 22523:2006Reference numberISO 22523:2006(E)INTERNATIONAL STANDARD ISO22523First edition2006-10-01External limb prostheses and external orthoses Requirements and test methods Prothses de membre externes et orthses exte

16、rnes Exigences et mthodes dessai EN ISO 22523:2006ii iiiContents Page Foreword vi Introduction vii 1 Scope . 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

17、 Strength and related conditions of use 5 5 Requirements for materials . 6 5.1 Flammability of materials and 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

18、.4 Resistance to corrosion and degradation 7 6 Noise and vibration. 7 7 Electromagnetic compatibility (EMC) . 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 Electro

19、nic programmable systems. 9 8.4 Electrically heated blankets, pads and similar flexible heating appliances. 9 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

20、8.6.3 Operation of radio equipment by the user . 9 9 Surface temperature. 10 10 Sterility. 10 11 Design requirements 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

21、Ergonomic principles . 11 13 Information supplied by the manufacturer 11 13.1 General. 11 13.2 Labelling 12 13.3 Intended use 12 14 Packaging 12 EN ISO 22523:2006iv Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic devices . 13 Annex B (normative) Method

22、of determining the mechanical properties of knee joint assemblies for lower-limb orthotic devices 28 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 establ

23、ishing the force or moment required to operate the control and actuating mechanisms on prosthetic and orthotic devices 55 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 sa

24、mple segment lengths . 15 Figure A.2 Configuration of test 1 . 16 Figure A.3 Configuration of test 2 and test 4 17 Figure A.4 Configuration of test 3 and test 5 17 Figure A.5 Examples of test sample configurations 18 Figure B.1 Example of a test rig design suitable for the application of the four-po

25、int loading system 34 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 mutual

26、ly at right angles (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 dimension

27、s trans-femoral (above-knee) Finished limb 48 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

28、heat source test 51 Figure C.6 Flaming ignition source test 52 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

29、.3 Test set-up according to D.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 f

30、or sample category D.3.1 c) Prosthetic knee units with locking mechanism (continued from Figure D.4) 72 EN ISO 22523:2006vFigure D.6 Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units with locking mechanism 72 Figure D.7 Test set-up according to D.6.6 for sample categ

31、ory 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 according to D.6.8 for sample category D.3.1 g) Terminal devices with built-in openi

32、ng 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.6.10 for sample category D.3.1 i) Terminal devices with no built-in closing or

33、 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 according to D.6.12 for sample category D.3.1 k) Prosthetic devices with fail

34、-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 Table D.1 Parameters of the test set-up for sample category D.3.1 a) 60 Tabl

35、e 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 sample . 68 Table E.1 Correspondence between this International Standard an

36、d the essential principles of ISO/TR 16142 . 81 EN ISO 22523:2006vi 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 through ISO technica

37、l 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 collaborates closely wit

38、h 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 2. The main task of technical committees is to prepare International Standards. Draft Inter

39、national Standards adopted by the technical committees are circulated 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 document may

40、 be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22523 was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics. EN ISO 22523:2006viiIntroduction This International Standard has been prepared in close collaboratio

41、n with Technical 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 accorda

42、nce with the 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

43、 relationship 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 requirem

44、ents outlined 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

45、 EU Directive 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

46、 are as follows, 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), th

47、e requirements of lower-level standards take precedence over higher-level standards. Therefore, to address all requirements for a particular aid, it is necessary to consult first, standards of the lowest available level. This is a combined level 2- and 3-standard (lowest possible) for external limb

48、prostheses and external orthoses, as specified in the scope. In this International Standard, in addition to the reference to existing test standards, test methods for several types of prostheses and orthoses are specified in separate annexes A to D. Annex ZA is included to show the parts of this Eur

49、opean Standard which address the essential requirements of EU Directives 93/42/EEC and 99/5/EC. NOTE Although this International Standard does not contain references to the level 1-standard EN 12182 Technical aids for disabled persons General requirements and test methods, it is recommended that EN 12182 be consulted. EN ISO 22523:2006blank1External limb prostheses and external orthoses Requirements and test methods 1 Scope This International Standard specifies requirements and tes