EN ISO 22675:2006

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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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.

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be withdrawn at the latest by April 2007.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.
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)
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
ISO 22675:2006(E)
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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.
...