SIST EN ISO 10328:2006

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)

This International Standard 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. The tests described in this International Standard comprise principal static and cyclic tests for all components; a separate static test in torsion for all components; separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components; a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis; separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly. The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE 3), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.

Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen und Prüfverfahren (ISO 10328:2006)

WICHTIG  Diese Internationale Norm ist geeignet für die Bewertung der Konformität von prothetischen Hilfsmitteln/Strukturen der unteren Gliedmaßen mit den in 4.4 von ISO 22523:2006 (siehe Anmerkung 1) festgelegten Anforderungen an die Festigkeit. Auf dem Markt erhältliche Knöchel-Fuß-Passteile und Fußeinheiten, deren Übereinstimmung mit den in 4.4 von EN 12523:1999 festgelegten Anforderungen an die Festigkeit nachgewiesen wurde, indem sie den entsprechenden Prüfungen von ISO 10328:1996 unterzogen wurden, brauchen nicht erneut nach ISO 22675:2006 geprüft zu werden.
WARNUNG  Diese Internationale Norm ist nicht dazu geeignet, als Anleitung für die Auswahl eines bestimmten prothetischen Hilfsmittels/einer bestimmten prothetischen Struktur der unteren Gliedmaßen bei der Verordnung einer individuellen Prothese der unteren Gliedmaßen zu dienen! Jede Missachtung dieser Warnung kann zu einem Sicherheitsrisiko für Amputierte führen.
In dieser Internationalen Norm sind Verfahren für statische und dynamische Festigkeitsprüfungen an Prothesen der unteren Gliedmaßen festgelegt (siehe Anmerkung 2), wobei, typischerweise, zusammengesetzte Belastungen durch das Aufbringen einer einzelnen Prüfkraft erzeugt werden. Die zusammengesetzten Belastungen im Prüfling stehen im Zusammenhang mit den Höchstwerten der Belastungskomponenten, die normalerweise zu unterschiedlichen Zeitpunkten während der Standphase des Laufvorgangs auftreten.
Die in dieser Internationalen Norm beschriebenen Prüfungen umfassen
   statische und dynamische Hauptprüfungen für alle Bauteile;
   eine statische Zusatzprüfung gegen Torsion für alle Bauteile;
   statische und dynamische Zusatzprüfungen an Knöchel-Fuß-Passteilen und Fußeinheiten für alle Knöchel-Fuß-Passteile als Einzelbauteile einschließlich Knöcheleinheiten oder Knöchelbefestigungen und alle Fußeinheiten als Einzelbauteile;

Protheses - Essais portant sur la structure des protheses de membres inférieurs - Exigences et méthodes d'essai (ISO 10328:2006)

L'ISO 10328:2006 spécifie des modes opératoires d'essais de résistance statiques et cycliques des prothèses de membres inférieurs dans le cadre desquels, à une exception près, des contraintes combinées sont produites 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 du cycle de marche.
Les essais décrits dans l'ISO 10328:2006 comprennent
les essais principaux statiques et cycliques s'appliquant à tous les composants,
un essai statique en torsion s'appliquant à tous les composants,
les essais statiques et cycliques réalisés sur les ensembles cheville-pied et sur les pieds s'appliquant à tous les ensembles cheville-pied en tant que composants, y compris les chevilles ou leurs fixations et à tous les pieds en tant que composants,
un essai statique distinct de résistance à la rupture en flexion maximale du genou réalisé sur les articulations du genou et sur les éléments associés s'appliquant à tous les genoux ou les ensembles genou-tibia et aux composants adjacents assurant normalement l'arrêt de la flexion sur une prothèse complète,
les essais statiques et cycliques réalisés sur les verrous de genou s'appliquant à tous les mécanismes qui verrouillent l'articulation du genou en position étendue du genou ou de l'ensemble genou-tibia.
Les essais décrits dans l'ISO 10328:2006 s'appliquent à des types spécifiques de prothèses, à savoir, aux prothèses utilisées en cas de désarticulation de la cheville, aux prothèses transtibiales (pour amputation au niveau de la jambe, sous le niveau du genou), aux prothèses utilisées en cas de désarticulation du genou et aux prothèses transfémorales (au niveau de la cuisse, au-dessus du genou), aux prothèses utilisées en cas de désarticulation de la partie (inférieure) distale de la hanche et aux prothèses pour hémipelvectomie.

Protetika - Preskušanje strukture protez spodnjih okončin - Zahteve in preskusne metode (ISO 10328:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2006
• Withdrawal Date: 16-Aug-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 17-Aug-2016
• Due Date: 09-Sep-2016
• Completion Date: 17-Aug-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10328:2006 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)

Relations

• Replaced By: SIST EN ISO 10328:2016 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
• Effective Date: 01-Sep-2016
• Amended By: SIST EN ISO 10328:2006/kprA1:2013 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006/FDAM 1:2013)
• Effective Date: 08-Jun-2022
• Amended By: SIST EN ISO 10328:2006/kprA1:2013 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006/FDAM 1:2013)
• Effective Date: 01-Mar-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10328:2006
01-december-2006
3URWHWLND3UHVNXãDQMHVWUXNWXUHSURWH]VSRGQMLKRNRQþLQ=DKWHYHLQSUHVNXVQH
PHWRGH,62
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO 10328:2006)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO 10328:2006)
Protheses - Essais portant sur la structure des protheses de membres inférieurs -
Exigences et méthodes d'essai (ISO 10328:2006)
Ta slovenski standard je istoveten z: EN ISO 10328:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 10328:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 10328
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40

English Version
Prosthetics - Structural testing of lower-limb prostheses -
Requirements and test methods (ISO 10328:2006)
Prothèses - Essais portant sur la structure des prothèses Prothetik - Prüfung der Struktur von Prothesen der unteren
de membres inférieurs - Exigences et méthodes d'essai Gliedmaßen - Anforderungen und Prüfverfahren (ISO
(ISO 10328:2006) 10328:2006)
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 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 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10328:2006: E
worldwide for CEN national Members.

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EN ISO 10328:2006 (E)





Foreword


This document (EN ISO 10328:2006) 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", 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 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(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,
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 10328:2006 has been approved by CEN as EN ISO 10328:2006 without any
modifications.

2

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EN ISO 10328:2006 (E)



ANNEX ZA
(informative)

Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.


This European standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports corresponding essential
requirements of EU Directive 93/42/EEC concerning medical devices.

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.

The following clauses of this standard are likely to support requirements of Directive 93/42/EEC
concerning medical devices: 5, 6, 7, 8, 9, 10, 15, 16, 17, 20 and 21 (see Table ZA.1).

Compliance with this standard provides one means of conforming with the essential requirements
of the Directive concerned and associated EFTA regulations.


Table ZA.1 — Correspondence between this European Standard and EU Directives


Corresponding Essential Comments
Clauses of this European
Requirements of Directive

Standard
93/42/EEC
5; 6; 7; 8; 9; 10; 15; 16; 17 2, 4, 12.7.1
5; 20; 21 9.1
5; 20; 21 13.1 Essential requirement 13.1 is not fully
covered here; only the aspects of
classification are addressed.
21 13.3 k)

3

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INTERNATIONAL ISO
STANDARD 10328
First edition
2006-10-01


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 10328:2006(E)
©
ISO 2006

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ISO 10328:2006(E)
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ii © ISO 2006 – All rights reserved

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ISO 10328:2006(E)
Contents Page
Foreword. ix
Introduction . x
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Designations and symbols of test forces and moments. 3
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. 5
6.3.5 Bottom reference plane, B . 6
6.4 Reference points. 8
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 . 11
A K
6.8.4 Distance L . 11
BT
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. 21
9.1 General. 21
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
© ISO 2006 – All rights reserved iii

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ISO 10328:2006(E)
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
9.5.1 General . 22
9.5.2 Restriction. 23
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. 25
10.2 Types of test samples. 26
10.2.1 Complete structure . 26
10.2.2 Partial structure. 28
10.2.3 Any other structure. 28
10.3 Preparation of test samples. 28
10.4 Identification of test samples. 29
10.5 Alignment of test samples . 30
10.5.1 Test samples for principal tests and separate tests on knee locks . 30
10.5.2 Test samples for separate tests on ankle-foot devices and foot units . 30
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 . 31
10.6 Worst-case alignment position of test samples . 32
11 Responsibility for test preparation . 32
12 Test submission document. 33
12.1 General requirements . 33
12.2 Information required for test samples . 34
12.2.1 All test samples. 34
12.2.2 Test samples for tests on ankle-foot devices and foot units . 34
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints
and associated parts . 34
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. 35
12.3.4 For static ultimate strength tests . 35
12.3.5 For cyclic tests . 35
12.3.6 For tests in torsion. 35
12.3.7 For tests on ankle-foot devices and foot units . 36
13 Equipment. 36
13.1 General . 36
13.2 Equipment for the principal tests specified in 16.2 and 16.3 . 36
13.2.1 End attachments . 36
13.2.2 Jig (optional). 38
13.2.3 Test equipment. 38
13.3 Equipment for the separate static test in torsion specified in 17.1 . 40
13.3.1 Test equipment. 40
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 . 40
13.4.1 Test equipment. 40
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee
joints and associated parts specified in 17.3.44
13.5.1 Extension pieces. 44
13.5.2 Test equipment to perform static compression loading – (Compression testing machine
or other equipment) . 44
13.6 Equipment for the separate tests on knee locks specified in 17.4 . 44
13.6.1 End attachments . 44
13.6.2 Jig (optional). 44
13.6.3 Test equipment. 44
iv © ISO 2006 – All rights reserved

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ISO 10328:2006(E)
14 Accuracy. 45
14.1 General. 45
14.2 Accuracy of equipment . 45
14.3 Accuracy of procedure. 45
15 Test principles. 46
15.1 General. 46
15.2 Static test procedure . 46
15.3 Cyclic test procedure . 46
16 Test procedures – Principal structural tests . 46
16.1 Test loading requirements. 46
16.1.1 Preparation for test loading. 46
16.1.2 Application of test loading. 46
16.2 Principal static test procedure . 48
16.2.1 Principal static proof test. 48
16.2.2 Principal static ultimate strength test. 53
16.3 Principal cyclic test procedure. 57
16.3.1 General requirements. 57
16.3.2 Test method. 57
16.3.3 Performance requirements . 61
16.3.4 Compliance conditions . 61
17 Test procedures – Separate structural tests . 65
17.1 Separate static test in torsion . 65
17.1.1 General. 65
17.1.2 Purpose of test. 65
17.1.3 Test method. 65
17.1.4 Performance requirements . 67
17.1.5 Compliance conditions . 67
17.2 Separate tests on ankle-foot devices and foot units . 69
17.2.1 General. 69
17.2.2 Purpose of tests. 69
17.2.3 Separate static proof test for ankle-foot devices and foot units . 69
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units . 73
17.2.5 Separate cyclic test for ankle-foot devices and foot units. 78
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and
associated parts. 83
17.3.1 General. 83
17.3.2 Purpose of test. 83
17.3.3 Applicability of the test to specific test samples . 83
17.3.4 Test method. 84
17.3.5 Performance requirement . 84
17.3.6 Compliance conditions . 85
17.4 Separate tests on knee locks . 86
17.4.1 General. 86
17.4.2 Purpose of tests. 86
17.4.3 Separate static proof test for knee locks . 86
17.4.4 Separate static ultimate strength test for knee locks . 90
17.4.5 Separate cyclic test for knee locks. 92
18 Test laboratory/facility log .
...