EN ISO 10328:2016
(Main)Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.
WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen und Prüfverfahren (ISO 10328:2016)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs - Exigences et méthodes d'essai (ISO 10328:2016)
IMPORTANT - ISO 10328:2016 permet d'évaluer la conformité des prothèses/structures prothétiques de membre inférieur selon les exigences concernant la résistance spécifiées en 4.4 de l'ISO 22523:2006 (voir la NOTE 1). Les unités de pied et les ensembles cheville-pied prothétiques commercialisés, conformes aux exigences concernant la résistance spécifiées en 4.4 de l'ISO 22523:2006 après soumission aux essais appropriés de l'ISO 10328:2006, sont réputés conformes à l'ISO 22675:2016.
AVERTISSEMENT - ISO 10328:2016 ne peut pas servir de guide pour choisir une prothèse/structure prothétique lors de la prescription d'une prothèse de membre inférieur ! Ignorer cet avertissement peut entraîner des risques pour la sécurité des personnes amputées.
ISO 10328:2016 spécifie des modes opératoires d'essais de résistance statiques et cycliques des prothèses de membres inférieurs (voir la NOTE 2) qui produisent typiquement des contraintes combinées par l'application d'une force d'essai unique. Les contraintes combinées dans l'échantillon d'essai correspondent aux valeurs maximales des composantes des forces qui interviennent normalement à différents moments au cours de la phase d'appui du cycle de marche.
Protetika - Preskušanje strukture protez spodnjih okončin - Zahteve in preskusne metode (ISO 10328:2016)
POMEMBNO: ta mednarodni standard je primeren za oceno skladnosti protetičnih pripomočkov/struktur za spodnje okončine z zahtevami glede trdnosti, določenimi v točki 4.4 standarda ISO 22523:2006 (glej OPOMBA 1). Protetičnih pripomočkov za gleženj in stopalo ter enot za stopalo, ki so na voljo na tržišču in dokazano izpolnjujejo zahteve, podane v točki 4.4 standarda ISO 22523:2006, na podlagi opravljenih ustreznih preskusov v skladu s standardom ISO 10328:2006, ni treba znova preskusiti v skladu s standardom ISO 22675:2016.
OPOZORILO: ta mednarodni standard ni primeren za uporabo kot vodilo za izbiro določenega protetičnega pripomočka/strukture za spodnje okončine pri predpisovanju posamezne proteze za spodnje okončine. Morebitno neupoštevanje tega opozorila lahko pomeni varnostno tveganje za amputirance. Ta mednarodni standard določa postopke za preskušanje statične in ciklične trdnosti protez za spodnje okončine (glej OPOMBA 2), pri katerih se običajno ustvarijo sestavljene obremenitve na podlagi uporabe enkratne preskusne sile. Sestavljene obremenitve v preskusnem vzorcu se navezujejo na najvišje vrednosti sestavnih delov obremenitve, ki se običajno pojavijo v različnih obdobjih faze drže pri hoji.
Preskusi, opisani v tem mednarodnem standardu:
– glavni statični in ciklični preskus za vse sestavne dele;
– ločen statični preskus pri torziji za vse sestavne dele;
– ločen statični in ciklični preskus za pripomočke za gleženj in stopalo ter enote za stopalo za vse pripomočke za gleženj in stopalo kot samostojne sestavne dele, vključno z enotami za stopalo ali pripomočki za gleženj, ter za vse enote za stopalo kot samostojne sestavne dele;
– ločen statični preskus skrajne trdnosti v največjem upogibu kolena za kolenske sklepe in povezane dele za vse enote za koleno ali sestave za koleno in golen ter soležne sestavne dele, ki običajno zagotavljajo blokado upogiba pri celotni protezi;
– ločen statični in ciklični preskus za kolenske blokade za vse mehanizme, ki blokirajo kolenski spoj v iztegnjenem položaju kolenske enote ali sestava za koleno in golen.
Preskusi, opisani v tem mednarodnem standardu se uporabljajo za posebne vrste protez za disartikulacijo gležnja (glej OPOMBA 2), transtibialne (podkolenske) proteze, proteze za disartikulacijo kolena in transfemoralne (nadkolenske) proteze ter proteze za disartikulacijo distalnega (spodnjega) dela kolka in proteze, ki se uporabljajo po hemipelvektomiji (glej OPOMBA 3).
OPOMBA 1: preskuse je mogoče opraviti za celotne strukture, dele struktur ali posamezne sestavne dele.
OPOMBA 2: preskusi se uporabljajo samo za proteze za disartikulacijo gležnja, ki vključujejo sestavne dele (za stopalo) protetičnih pripomočkov za gleženj in stopalo, vzete iz običajne proizvodne linije.
OPOMBA 3: distalni del zajema enoto za koleno, pripomoček za gleženj in stopalo ter vse vmesne dele. Preskusi za kolčne enote so opisani v standardu ISO 15032.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2016
1DGRPHãþD
SIST EN ISO 10328:2006
3URWHWLND3UHVNXãDQMHVWUXNWXUHSURWH]VSRGQMLKRNRQþLQ=DKWHYHLQSUHVNXVQH
PHWRGH ,62
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO 10328:2016)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO 10328:2016)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs -
Exigences et méthodes d'essai (ISO 10328:2016)
Ta slovenski standard je istoveten z: EN ISO 10328:2016
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10328
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 10328:2006
English Version
Prosthetics - Structural testing of lower-limb prostheses -
Requirements and test methods (ISO 10328:2016)
Prothèses - Essais portant sur la structure des Prothetik - Prüfung der Struktur von Prothesen der
prothèses de membres inférieurs - Exigences et unteren Gliedmaßen - Anforderungen und
méthodes d'essai (ISO 10328:2016) Prüfverfahren (ISO 10328:2016)
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 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 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, 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN ISO 10328:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
European foreword
This document (EN ISO 10328:2016) has been prepared by Technical 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 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 not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 10328:2006.
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).
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, Bulgaria, 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10328:2016 has been approved by CEN as EN ISO 10328:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation 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 Directive 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, 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 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 manufacturer’s policy for determining acceptable risk has to be in 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 Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
With respect to use in
9.1 5 combination with other devices
or equipment.
With respect to any restrictions
on use which shall be indicated
9.1 20 and 21
on the label or in the instructions
for use.
Only covered for mechanical
12.7.1 5, 7, 8, 9, 10, 15, 16, 17 and 18
strength.
Essential requirement 13.1 is not
fully covered here; only the
13.1 5, 20, and 21.4
aspects
of classification are addressed.
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
Only covered for classification of
13.3 b) 21
the use of the device.
Only covered for limitations due
to body mass limit and specific
13.3 k) 21.2
activities undertaken by the
user.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 10328
Second edition
2016-06-01
Prosthetics — Structural testing
of lower-limb prostheses —
Requirements and test methods
Prothèses — Essais portant sur la structure des prothèses de membres
inférieurs — Exigences et méthodes d’essai
Reference number
ISO 10328:2016(E)
©
ISO 2016
ISO 10328:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 10328:2016(E)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Designations and symbols of test forces and moments . 2
5 Strength and related performance requirements and conditions of use .3
6 Coordinate systems and test configurations . 5
6.1 General . 5
6.2 Axes of coordinate systems . 5
6.3 Reference planes . 5
6.3.1 General. 5
6.3.2 Top reference plane, T . 5
6.3.3 Knee reference plane, K . 5
6.3.4 Ankle reference plane, A . 6
6.3.5 Bottom reference plane, B . 6
6.4 Reference points . 7
6.5 Test force . 8
6.6 Load line . 8
6.7 Longitudinal axis of the foot and effective joint centres and centrelines . 8
6.7.1 General. 8
6.7.2 Longitudinal axis of the foot . 8
6.7.3 Effective ankle-joint centre . 8
6.7.4 Effective ankle-joint centreline .10
6.7.5 Effective knee-joint centreline .10
6.7.6 Effective knee-joint centre .11
6.8 Reference distances .11
6.8.1 Offsets .11
6.8.2 Combined offsets .11
6.8.3 Effective lever arms L and L .
A K 11
6.8.4 Distance L .
BT 11
7 Test loading conditions and test loading levels .11
7.1 Test loading conditions .11
7.1.1 General.11
7.1.2 Test loading conditions of principal structural tests .12
7.1.3 Test loading conditions of separate structural tests .12
7.2 Test loading levels .12
8 Values of test loads, dimensions and cycles .13
9 Compliance .20
9.1 General .20
9.2 Selection of tests required to claim compliance with this International Standard .21
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot
devices or foot units, required to claim compliance with this International Standard .21
9.3.1 General.21
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit .21
9.3.3 Particular arrangements and requirements concerning the part required
to connect the ankle-foot device or foot unit to the remainder of the
prosthetic structure .21
9.4 Number of tests and test samples required to claim compliance with this
International Standard .22
9.5 Multiple use of test samples .22
ISO 10328:2016(E)
9.5.1 General.22
9.5.2 Restriction .22
9.6 Testing at particular test loading levels not specified in this International Standard .23
10 Test samples .25
10.1 Selection of test samples .25
10.1.1 General.25
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot .26
10.2 Types of test samples .27
10.2.1 Complete structure .27
10.2.2 Partial structure .29
10.2.3 Any other structure .29
10.3 Preparation of test samples .29
10.4 Identification of test samples .30
10.5 Alignment of test samples .31
10.5.1 Test samples for principal tests and separate tests on knee locks .31
10.5.2 Test samples for separate tests on ankle-foot devices and foot units .31
10.5.3 Test samples for separate static ultimate strength tests in maximum knee
flexion for knee joints and associated parts .31
10.5.4 Test samples for separate tests on knee locks .32
10.6 Worst-case alignment position of test samples .32
11 Responsibility for test preparation .33
12 Test submission document .34
12.1 General requirements .34
12.2 Information required for test samples .35
12.2.1 All test samples .35
12.2.2 Test samples for tests on ankle-foot devices and foot units .35
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion
for knee joints and associated parts .35
12.3 Information required for tests .35
12.3.1 General.35
12.3.2 For all tests .35
12.3.3 For static tests in torsion and on ankle-foot devices and foot units .36
12.3.4 For static ultimate strength tests .36
12.3.5 For cyclic tests .36
12.3.6 For tests in torsion .36
12.3.7 For tests on ankle-foot devices and foot units .36
13 Equipment .37
13.1 General .37
13.2 Equipment for the principal tests specified in 16.2 and 16.3 .37
13.2.1 End attachments .37
13.2.2 Jig (optional) .39
13.2.3 Test equipment .40
13.3 Equipment for the separate static test in torsion specified in 17.1 .42
13.3.1 Test equipment .42
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 .42
13.4.1 Test equipment .42
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion
for knee joints and associated parts specified in 17.3 .46
13.5.1 Extension pieces .46
13.5.2 Test equipment to perform static compression loading – (Compression
testing machine or other equipment).46
13.6 Equipment for the separate tests on knee locks specified in 17.4 .46
13.6.1 End attachments .46
13.6.2 Jig (optional) .46
13.6.3 Test equipment .46
14 Accuracy .47
iv © ISO 2016 – All rights reserved
ISO 10328:2016(E)
14.1 General .47
14.2 Accuracy of equipment .47
14.3 Accuracy of procedure .47
15 Test principles .48
15.1 General .48
15.2 Static test procedure .48
15.3 Cyclic test procedure .48
16 Test procedures – Principal structural tests.48
16.1 Test loading requirements .48
16.1.1 Preparation for test loading .48
16.1.2 Application of test loading .48
16.2 Principal static test procedure .50
16.2.1 Principal static proof test .50
16.2.2 Principal static ultimate strength test .55
16.3 Principal cyclic test procedure .59
16.3.1 General requirements .59
16.3.2 Test method .59
16.3.3 Performance requirements .63
16.3.4 Compliance conditions .64
17 Test procedures — Separate structural tests .68
17.1 Separate static test in torsion .68
17.1.1 General.68
17.1.2 Purpose of test .68
17.1.3 Test method .68
17.1.4 Performance requirements .70
17.1.5 Compliance conditions .70
17.2 Separate tests on ankle-foot devices and foot units .72
17.2.1 General.72
17.2.2 Purpose of tests.72
17.2.3 Separate static proof test for ankle-foot devices and foot units .72
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units .76
17.2.5 Separate cyclic test for ankle-foot devices and foot units .81
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and
associated parts.86
17.3.1 General.86
17.3.2 Purpose of test .86
17.3.3 Applicability of the test to specific test samples .86
17.3.4 Test method .87
17.3.5 Performance requirement .88
17.3.6 Compliance conditions .88
17.4 Separate tests on knee locks .89
17.4.1 General.89
17.4.2 Purpose of tests.90
17.4.3 Separate static proof test for knee locks .90
17.4.4 Separate static ultimate strength test for knee locks .94
17.4.5 Separate cyclic test for knee locks .96
18 Test laboratory/facility log .105
18.1 General requirements .105
18.2 Specific requirements .105
19 Test report .105
19.1 General requirements .105
19.2 Specific requirements .106
19.3 Options .106
20 Classification and designation .106
20.1 General .106
ISO 10328:2016(E)
20.2 Examples of classification and designation .106
21 Labelling .107
21.1 General .107
21.2 Use of mark “*)” and warning symbol .108
21.3 Examples of label layout .108
21.4 Label placement .108
Annex A (informative) Description of internal loads and their effects .110
Annex B (informative) Reference data for the specification of test loading conditions and
test loading levels of principal cyclic tests.114
Annex C (informative) Guidance on the application of an alternative static ultimate
strength test .118
Annex D (normative) Guidance on the application of an additional test loading levels P6, P7
and P8 .119
Annex E (informative) Summary of the records to be entered in the test laboratory/facility log 122
Annex F (informative) Background information on the loading profiles generated by test
equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and
foot units according to 17.2.5.1 .137
Annex G (informative) Reference to the essential principles of safety and performance of
medical devices according to ISO/TR 16142 .139
Bibliography .140
vi © ISO 2016 – All rights reserved
ISO 10328:2016(E)
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 technical 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 with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 168, Prosthetics and orthotics.
This second edition cancels and replaces the first edition ISO 10328:2006 which has been technically
revised with the following changes:
a) Test loading levels P7 and P8 have been introduced in Table B.1, Table B.2, Table B.3, Table 4.1,
Table D.1, Table D.2, Table D.3 and the clauses pointing at these tables have been updated. Additional
information on P7 and P8 is given in Annex B.1;
b) Table 9 has been revised;
c) Annex D has changed from informative to normative.
ISO 10328:2016(E)
Introduction
Throughout this International Standard, the term prosthesis means an externally applied device used
to replace wholly, or in part, an absent or deficient limb segment.
As a result of concern in the international community about the need to provide prostheses that are
safe in use, and also because of an awareness that test standards would assist the development of better
prostheses, a series of meetings was held under the aegis of the International Society for Prosthetics
and Orthotics (ISPO). The final one was held in Philadelphia, PA, USA in 1977 at which a preliminary
consensus was reached on methods of testing and the required load values. From 1979 onwards this
work was continued by ISO Technical Committee 168 leading to the development of ISO 10328:1996.
The test procedures may not be applicable to prostheses of mechanical characteristics different from
those used in the consensus.
During use, a prosthesis is subjected to a series of load actions, each varying individually w
...
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