SIST EN ISO 22675:2006
(Main)Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test. According to the concept of the tests of this International Standard, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO 22675:2006)
WICHTIG Diese Internationale Norm ist geeignet für die Bewertung der Konformität von prothetischen Knöchel-Fuß-Passteilen und Fußeinheiten nach den in 4.4 von ISO 22523:2006 festgelegten Anforderungen zur Festigkeit (siehe Anmerkung 1). 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 dieser Internationalen Norm geprüft zu werden.
WARNUNG Diese Internationale Norm ist nicht dazu geeignet, als Anleitung für die Auswahl eines bestimmten Knöchel-Fuß-Passteils oder einer Fußeinheit 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 ist in erster Linie ein dynamisches Prüfverfahren für Knöchel-Fuß-Passteile und Fußeinheiten von externen Prothesen der unteren Gliedmaßen festgelegt, die sich durch die Möglichkeit unterscheiden, die Belastungsbedingungen der gesamten Standphase des Laufvorgangs vom Fersenauftritt bis zum Zehenabheben wirklichkeitsnah zu simulieren, die für die Verifizierung von Leistungsanforderungen, wie z. B. Festigkeit, Dauerhaftigkeit und Lebensdauer, entscheidend sind.
Dieses Potential ist von besonderer Bedeutung für die Bewertung der Gebrauchstauglichkeit einer Vielzahl an neuen Konstruktionen von Knöchel-Fuß-Passteilen und Fußeinheiten mit bestimmten Merkmalen, die nur unter wirklichkeitsnahen Belastungsbedingungen zutage treten.
Protheses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai (ISO 22675:2006)
L'ISO 22675:2006 spécifie essentiellement un mode opératoire d'essais cycliques portant sur les ensembles cheville-pied et les unités de pied des prothèses externes pour membres inférieurs. Ce mode opératoire se distingue par la possibilité de modéliser de manière réaliste les conditions de mise en contrainte pendant la phase complète d'appui lors de la marche (depuis l'attaque au talon jusqu'au décollement des orteils), qui sont pertinentes pour la vérification des exigences de performances telles que la résistance, la durabilité et la durée de vie de l'appareil.
En outre, l'ISO 22675:2006 spécifie un mode opératoire d'essai statique portant sur les ensembles cheville-pied et unités de pied prothétiques, qui comprend un essai statique de charge et un essai de résistance à la rupture. L'essai se distingue, entre autres, par la possibilité de générer des forces du talon et de l'avant du pied au niveau de lignes d'action comparables à celles développées au moment où s'exercent les contraintes maximales au niveau du talon et de l'avant du pied lors de l'essai cyclique.
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo - Zahteve in preskusne metode (ISO 22675:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22675:2006
01-december-2006
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO 22675:2006)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO 22675:2006)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO 22675:2006)
Protheses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO 22675:2006)
Ta slovenski standard je istoveten z: EN ISO 22675:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 22675:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 22675
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40
English Version
Prosthetics - Testing of ankle-foot devices and foot units -
Requirements and test methods (ISO 22675:2006)
Prothèses - Essais d'articulations cheville-pied et unités de Prothetik - Prüfung von Knöchel-Fuß-Passteilen und
pied - Exigences et méthodes d'essai (ISO 22675:2006) Fußeinheiten - Anforderungen und Prüfverfahren (ISO
22675:2006)
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,
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Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22675:2006: E
worldwide for CEN national Members.
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EN ISO 22675:2006 (E)
Foreword
This document (EN ISO 22675:2006) 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 22675:2006 has been approved by CEN as EN ISO 22675:2006 without any
modifications.
2
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EN ISO 22675:2006 (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.
20 13.3 k)
3
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INTERNATIONAL ISO
STANDARD 22675
First edition
2006-10-01
Prosthetics — Testing of ankle-foot
devices and foot units — Requirements
and test methods
Prothèses — Essais d'articulations cheville-pied et unités de pied —
Exigences et méthodes d'essai
Reference number
ISO 22675:2006(E)
©
ISO 2006
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ISO 22675:2006(E)
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ii © ISO 2006 – All rights reserved
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ISO 22675:2006(E)
Contents Page
Foreword. vii
Introduction . viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Designations and symbols of test forces . 2
5 Strength and related performance requirements and conditions of use. 3
6 Coordinate system and test configurations . 4
6.1 General. 4
6.2 Origin and axes of the coordinate system . 4
6.3 Reference points. 5
6.4 Test force F. 6
6.5 Line of application of test force F . 6
6.6 Lines of action of resultant reference forces F and F . 6
R1 R2
6.7 Longitudinal axis of the foot and effective ankle joint centre. 6
6.7.1 General. 6
6.7.2 Longitudinal axis of the foot. 6
6.7.3 Effective ankle-joint centre, C . 7
A
7 Test loading conditions and test loading levels. 8
7.1 Test loading conditions. 8
7.2 Test loading levels. 8
8 Values of test forces, dimensions and cycles . 9
9 Compliance. 16
9.1 General. 16
9.2 Particular arrangements and requirements concerning the part required to connect an
ankle-foot device or foot unit to the remainder of a prosthetic structure . 17
9.2.1 Arrangements for testing. 17
9.2.2 Requirements for claiming compliance.17
9.3 Number of tests and test samples required to claim compliance with this International
Standard . 17
9.4 Multiple use of test samples. 18
9.4.1 General. 18
9.4.2 Restriction . 18
9.5 Testing at particular test loading levels not specified in this International Standard. 18
10 Test samples . 19
10.1 Selection of test samples. 19
10.1.1 General. 19
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot. 19
10.2 Types of test sample . 20
10.2.1 Complete structure. 20
10.2.2 Partial structure . 20
10.3 Preparation of test samples. 20
10.4 Identification of test samples . 21
10.5 Alignment of test samples . 21
10.6 Worst-case alignment position of test samples . 21
11 Responsibility for test preparation . 23
12 Test submission document . 24
12.1 General requirements. 24
12.2 Information required for test samples. 24
12.3 Information required for tests . 25
12.3.1 General. 25
12.3.2 For all tests. 25
12.3.3 For the static proof test and the static ultimate strength test . 25
© ISO 2006 – All rights reserved iii
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ISO 22675:2006(E)
12.3.4 For the static ultimate strength test. 25
12.3.5 For the cyclic test. 25
13 Equipment. 26
13.1 General . 26
13.2 End attachments . 26
13.2.1 General . 26
13.2.2 Proof test of end attachments . 26
13.3 Jig (optional). 28
13.4 Test equipment. 28
13.4.1 Test equipment to perform static heel and forefoot loading. 28
13.4.2 Test equipment to perform cyclic loading.30
14 Accuracy . 37
14.1 General . 37
14.2 Accuracy of equipment . 37
14.3 Accuracy of procedure . 38
15 Test principles. 38
15.1 General . 38
15.2 Static test procedure . 39
15.3 Cyclic test procedure. 39
16 Test procedures . 39
16.1 Test loading requirements . 39
16.1.1 Preparation for test loading . 39
16.1.2 Test loading conditions. 43
16.2 Static proof test. 43
16.2.1 Test method. 43
16.2.2 Performance requirement . 45
16.2.3 Compliance conditions. 45
16.3 Static ultimate strength test. 47
16.3.1 Test method. 47
16.3.2 Performance requirements . 50
16.3.3 Compliance conditions. 50
16.4 Cyclic test . 52
16.4.1 Test method. 52
16.4.2 Performance requirements . 54
16.4.3 Compliance conditions. 55
17 Test laboratory/facility log . 58
17.1 General requirements . 58
17.2 Specific requirements. 58
18 Test report. 58
18.1 General requirements . 58
18.2 Specific requirements. 59
18.3 Options. 59
19 Classification and designation . 59
19.1 General . 59
19.2 Examples of classification and designation . 59
20 Labelling. 60
20.1 General . 60
20.2 Use of mark "*)" and warning symbol. 61
20.3 Examples of label layout . 61
20.4 Label placement . 62
Annex A (informative) Reference data for the specification of the test loading conditions and test
loading levels of this International Standard .63
Annex B (informative) Guidance on the application of an alternative static ultimate strength test . 71
Annex C (informative) Guidance on the application of an additional test loading level P6. 72
Annex D (informative) Summary of the records to be entered in the test laboratory/facility log . 74
[1]
Annex E (informative) Information on Technical Report ISO/TR 22676 . 80
Annex F (informative) Reference to the essential principles of safety and performance of medical
devices according to ISO/TR 16142 . 91
Bibliography . 92
iv © ISO 2006 – All rights reserved
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ISO 22675:2006(E)
Figure 1 — Coordinate system with reference parameters. 5
Figure 2 — Determination of longitudinal axis of foot (see 6.7.2) and effective ankle-joint centre
C (see 6.7.3) . 7
A
Figure 3 — Illustration of reference points for the establishment of thresholds listed in Table 10
for specification of the loading profile of the cyclic test. 14
Figure 4 — Illustration of specific set-up of left-sided test sample with top load application
point P . 23
T
Figure 5 — Diagrammatic view of test equipment according to 13.4.1 and 13.4.2 with test sample. 35
Figure 6 — Profiles of test force F (t) and tilting angle γ(t) as synchronized functions of time,
c
determining the loading condition of the cyclic test of this International Standard . 36
Figure 7 — Test force F (γ) of test loading level P5 as function of tilting angle γ(t) of foot platform. 37
c
Figure 8 — Preparation for test loading of static test procedure [see 16.1.1 a)] . 42
Figure 9 — Flowchart for the static proof test specified in 16.2.1.46
Figure 10 — Flowchart for the static ultimate strength test specified in 16.3.1. 51
Figure 11 — Flowchart for the cyclic test specified in 16.4.1 Continued on Figure 12. 56
Figure 12 — Flowchart for the cyclic test specified in 16.4.1 Continued from Figure 11 . 57
Figure 13 — General concept for the label layout. 60
Figure 14 — Models for the label layout. 61
Figure A.1 — Illustration of different components of loading. 69
Figure A.2 — Illustration of the dependence of the position of the top load application point P on
T
the foot length L — (see A.2.2.3). 70
Figure E.1 — Effect of f-position of tilting axis TA of foot platform on the elevation E of the foot at
the instants of heel contact and toe-off. 83
Figure E.2 — Effect of u-position of tilting axis TA of foot platform on the A/P displacement ∆f of
the foot at the instant of toe-off. 84
Figure E.3 — Illustration of the effect of A-P displacement ∆f on the angular movement ∆ϕ
of the test sample about the top load application point P . 85
T
Figure E.4 — Illustration of possibilities of transposing the top load application point P
T
for compensation of the dependence of the position of the tilting axis TA of the foot
platform on the foot length L . 88
Figure E.5 — Illustration of the effect of a fixed compromise offset u of the tilting axis TA
TA, C
of the foot platform on the A-P displacement ∆f at the foot [see E.3.4.2 c) 2)] . 89
Table 1 — Designations and symbols of test forces . 2
Table 2 — Categories of strength addressed in this International Standard, together with the
related performance requirements and test methods for their verification . 3
Table 3 — Test forces and relevant references . 9
Table 4 — Values of bottom offsets f (heel) and f (forefoot) for given values of foot length
B1, L B2, L
L, relevant to the design and/or adjustment of the rigid foot dummy required to simulate
the effective lever arms of an ankle-foot device or foot unit in the proof test of end
attachments (see 13.2.2) . 10
Table 5 — Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1). 10
© ISO 2006 – All rights reserved v
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ISO 22675:2006(E)
Table 6 — Total length of test samples and segmental lengths of end attachments. 11
Table 7 — Coordinates of top load application point P and tilting axis TA of foot platform based
T
on given values of foot length L, for all test loading levels. 12
Table 8 — Angles of toe-out position of foot and specific tilting positions of foot platform, for all
test loading levels . 12
Table 9 — Tes
...
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