DIN EN ISO 22675-2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675 2016) German version EN ISO 22675 2016《假肢 脚踝装置和脚部件试验 要求和.pdf

1、December 2016 English price group 32No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.180.10!%_-J“2601039www.din.d

2、eDIN EN ISO 22675Prosthetics Testing of anklefoot devices and foot units Requirements and test methods (ISO 22675:2016);English version EN ISO 22675:2016,English translation of DIN EN ISO 22675:2016-12Prothetik Prfung von KnchelFuPassteilen und Fueinheiten Anforderungen und Prfverfahren (ISO 22675:2

3、016);Englische Fassung EN ISO 22675:2016,Englische bersetzung von DIN EN ISO 22675:2016-12Prothses Essais darticulations chevillepied et units de pied Exigences et mthodes dessai (ISO 22675:2016);Version anglaise EN ISO 22675:2016,Traduction anglaise de DIN EN ISO 22675:2016-12SupersedesDIN EN ISO 2

4、2675:200704www.beuth.deDocument comprises 104 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 22675:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22675:2016) has been

5、prepared by Technical Committee ISO/TC 168 “Prosthetics and orthotics” in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” (Secretariat: SIS, Sweden), in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement) an

6、d with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-03 AA Orthopdietechnik. EN ISO 22675:2016, together with Eur

7、opean Standards EN ISO 10328:2016 and EN ISO 22523:2006, gives an overview of specifications which provide the means of applying the essential requirements of Annex I of the EU Medical Devices Directive on medical devices to external limb prostheses and external orthoses (the Directive has been impl

8、emented in Germany by the German Medical Devices Act (Medizinproduktegesetz MPG) see also Annex F of this standard). EN ISO 22675:2016 specifies alternative methods of testing the proof, ultimate and fatigue strength of anklefoot devices and foot units. (These methods differ considerably from those

9、specified in EN ISO 10328:2016; see the Introduction and Scope of the present standard.) To ensure that an ankle-foot device or foot unit has the strength to sustain the loads occurring during use by amputees in the manner intended, this standard has introduced the following special safety concept i

10、n Clause 5. Thus, EN ISO 22675:2016 applies a special safety concept: a) the ankle-foot device or foot unit shall comply with the requirements specified in this standard for a specific test loading level and b) the ankle-foot device or foot unit shall only be used by amputees with a body mass below

11、the limit specified by the manufacturer in consideration of the intended use of that ankle-foot device or foot unit. The conditions specified in a) and b) must be met as regards both the classification and designation of the device or unit (see Clause 19) and their labelling (see Clause 20). Since D

12、IN EN ISO 22675:2016 is a harmonized standard, ankle-foot devices and foot units as in this standard can be assumed to meet the relevant stipulations of the German Medical Devices Act (MPG). The so-called “presumption of conformity” in the application of harmonized standards can simplify the declara

13、tion of conformity as a prerequisite for the CE conformity marking of these products. As described in the third paragraph of this National Foreword, the present standard and EN ISO 22675:2016 and EN ISO 10328:2016 both specify methods of testing prosthetic ankle-foot devices and foot units. A transi

14、tion period will be established during which both test methods are valid (see the introductions to these two standards). The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 10328:2016 DIN EN ISO 10328:2016-12 ISO 22523:2006 DIN

15、EN ISO 22523:2007-04 DIN EN ISO 22675:2016-12 3 Amendments This standard differs from DIN EN ISO 22675:2007-04 as follows: a) test loading levels P7 and P8 have been added in Table 10, Table A.1, Table C.1, Table C.2 and the subparagraphs which refer to these tables have been revised. Additional inf

16、ormation on P7 and P8 is given in Annex A.1; b) Table 9 has been revised; c) Annex C has been changed from informative to normative. Previous editions DIN EN ISO 22675: 2007-04 DIN EN ISO 22675:2016-12 4 National Annex NA (informative) Bibliography DIN EN ISO 10328:2016-12, Prosthetics Structural te

17、sting of lower-limb prostheses Requirements and test methods (ISO 10328:2016) DIN EN ISO 22523:2007-04, External limb prostheses and external orthoses Requirements and test methods (ISO 22523:2006) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22675 June 2016 ICS 11.040.40 Supersedes EN I

18、SO 22675:2006English Version Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) Prothses - Essais darticulations cheville-pied et units de pied - Exigences et mthodes dessai(ISO 22675:2016) Prothetik - Prfung von Knchel-Fu-Passteilen und Fuein

19、heiten - Anforderungen und Prfverfahren(ISO 22675:2016) This European Standard was approved by CEN on 12 May 2016. 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 without any

20、alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language

21、 made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, E

22、stonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR S

23、TANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22675:2016 EForeword .8Introduct

24、ion 91 Scope 102 Normative references . 103 Terms and definitions 114 Designations and symbols of test forces . 115 Strength and related performance requirements and conditions of use . 126 Coordinate system and test configurations . 136.1 General 136.2 Origin and axes of the coordinate system . 136

25、.3 Reference points . 146.4 Test force F 156.5 Line of application of test force F 156.6 Lines of action of resultant reference forces FR1and FR2156.7 Longitudinal axis of the foot and effective ankle joint centre 156.7.1 General. 156.7.2 Longitudinal axis of the foot . 156.7.3 Effective ankle-joint

26、 centre, CA167 Test loading conditions and test loading levels . 177.1 Test loading conditions . 177.2 Test loading levels . 178 Values of test forces, dimensions and cycles 189 Compliance 259.1 General 259.2 Particular arrangements and requirements concerning the part required to connect an ankle-f

27、oot device or foot unit to the remainder of a prosthetic structure .269.2.1 Arrangements for testing 269.2.2 Requirements for claiming compliance 269.3 Number of tests and test samples required to claim compliance with this International Standard 269.4 Multiple use of test samples . 279.4.1 General.

28、 279.4.2 Restriction 279.5 Testing at particular test loading levels not specified in this International Standard .2710 Test samples .2810.1 Selection of test samples . 2810.1.1 General. 2810.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot 2810.2 Types of test sample 2

29、910.2.1 Complete structure .2910.2.2 Partial structure 2910.3 Preparation of test samples 2910.4 Identification of test samples 3010.5 Alignment of test samples 3010.6 Worst-case alignment position of test samples .30Contents PageEuropean foreword 5 Annex ZA (informative) Relationship between this E

30、uropean Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be covered 6.2DIN EN ISO 22675:2016-12 EN ISO 22675:2016 (E) 12.3 Information required for tests 3412.3.1 General. 3412.3.2 For all tests . 3412.3.3 For the static proof test and the static ultimate strength

31、test .3412.3.4 For the static ultimate strength test .3412.3.5 For the cyclic test 3413 Equipment 3513.1 General 3513.2 End attachments . 3513.2.1 General. 3513.2.2 Proof test of end attachments 3513.3 Jig (optional) 3613.4 Test equipment 3813.4.1 Test equipment to perform static heel and forefoot l

32、oading 3813.4.2 Test equipment to perform cyclic loading 3914 Accuracy .4614.1 General 4614.2 Accuracy of equipment . 4614.3 Accuracy of procedure . 4615 Test principles 4715.1 General 4715.2 Static test procedure . 4815.3 Cyclic test procedure . 4816 Test procedures 4816.1 Test loading requirements

33、 . 4816.1.1 Preparation for test loading 4816.1.2 Test loading conditions .5216.2 Static proof test 5216.2.1 Test method . 5216.2.2 Performance requirement 5416.2.3 Compliance conditions 5416.3 Static ultimate strength test . 5616.3.1 Test method . 5616.3.2 Performance requirements 5916.3.3 Complian

34、ce conditions 5916.4 Cyclic test 6016.4.1 Test method . 6016.4.2 Performance requirements 6316.4.3 Compliance conditions 6417 Test laboratory/facility log .6617.1 General requirements 6617.2 Specific requirements 6618 Test report 6618.1 General requirements 6618.2 Specific requirements 6718.3 Option

35、s 6719 Classification and designation 6719.1 General 6719.2 Examples of classification and designation .6711 Responsibility for test preparation 3212 Test submission document .3312.1 General requirements 3312.2 Information required for test samples 333DIN EN ISO 22675:2016-12 EN ISO 22675:2016 (E)An

36、nex A (informative) Reference data for the specification of the test loading conditions and test loading levels of this International Standard .71Annex B (informative) Guidance on the application of an alternative static ultimate strength test .79Annex C (normative) Application of an additional test

37、 loading level P6, P7, and P8 80Annex D (informative) Summary of the records to be entered in the test laboratory/facility log 82Annex E (informative) Information on Technical Report ISO/TR 22676188Annex F (informative) Reference to the essential principles of safety and performance of medical devic

38、es according to ISO/TR 16142 .99Bibliography 10020 Labelling .6820.1 General 6820.2 Use of mark “*)” and warning symbol 6920.3 Examples of label layout 6920.4 Label placement 704DIN EN ISO 22675:2016-12 EN ISO 22675:2016 (E) European foreword This document (EN ISO 22675:2016) has been prepared by Te

39、chnical Committee ISO/TC 168 “ Prosthetics and orthoticsa“ 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

40、an identical text or by endorsement, at the latest by December 2016, and conflicting national standards shall be withdrawn at the latest by December 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall no

41、t be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 22675:2006. 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(s). Fo

42、r relationship with EU Directive(s), see informative Annex ZA, B, C or D, 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, Bu

43、lgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

44、Turkey and the United Kingdom. Endorsement notice The text of ISO 22675:2016 has been approved by CEN as EN ISO 22675:2016 without any modification. 5DIN EN ISO 22675:2016-12 EN ISO 22675:2016 (E)Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU

45、Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions standardization request M/023 concerning the development of European standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Di

46、rective 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard,

47、a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC

48、 as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk has to be in

49、compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European standard and A