EN ISO 22675:2006/FprA1

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006/FDAM 1:2015)

2015-11-30: Project cancelled in ISO, awaiting BT decision to cancel CEN project (notification to dataservice 2015-11-12).

Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO 22675:2006/FDAM 1:2015)

Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai (ISO 22675:2006/FDAM 1:2015)

Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo - Zahteve in preskusne metode (ISO 22675:2006/DAM 1:2011)

General Information

• Status: Not Published
• Publication Date: 18-Nov-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 5098 - Decision to abandon - Formal Approval
• Start Date: 12-Jan-2016
• Completion Date: 14-Apr-2025
• 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: SIST EN ISO 22675:2006/kprA1:2015 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006/DAM 1:2011)

Relations

• Amends: EN ISO 22675:2006 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
• Effective Date: 08-Jun-2022

Overview

EN ISO 22675:2006/FprA1 is a CEN draft amendment to ISO 22675:2006 covering requirements and test methods for ankle-foot devices and foot units used in prosthetics. The draft amendment was prepared by ISO/TC 168 in collaboration with CEN/TC 293 and, if approved, modifies EN ISO 22675:2006. The amendment focuses on expanded test loading levels and updates to test procedures, tables and normative annexes. Note: the CEN project status indicates a 2015 notification that the ISO project was cancelled and the CEN project was awaiting a BT decision (notification to dataservice 2015-11-12).

Key Topics

• Additional test loading levels (P6, P7, P8): The amendment introduces higher test loading levels to allow structural testing of prostheses for heavier users and more demanding field conditions. Annex C is updated and changed from informative to normative to support these levels.
• Updates to tables and forces: Multiple tables and clauses are revised to specify test forces, dimensions and cycle prescriptions for the new loading levels. References in Tables 5–10, A.1 and Annex C are amended to include P6–P8 values and to direct users to the new normative content.
• Test procedure alignment: The draft clarifies how the new levels apply to principal structural tests and separate structural tests on ankle-foot devices and foot units, and specifies where to make explicit reference if additional loading levels are applied.
• Normative Annex C: Annex C becomes normative and provides the application of additional loading levels including derivation notes and force relationships relevant to proof, stabilizing and settling tests.

Applications

This amendment is of practical value to:

• Manufacturers - to design, validate and certify ankle-foot devices and foot units for a wider range of users and loading conditions.
• Test laboratories - to implement revised static and cyclic test setups, refer to updated tables for forces and cycles, and adopt Annex C when applying P6–P8 levels.
• Clinicians and prosthetists - to understand the structural validation levels used by manufacturers and labs when selecting components for higher-mass users.
• Regulatory bodies - to assess conformity with EU-related mandates and essential requirements supported by the CEN work.

Benefits include clearer criteria for structural testing, harmonised test loading across laboratories and improved traceability of test parameters when higher loading levels are required.

Related Standards

• ISO 22675:2006 - the parent international standard for testing ankle-foot devices and foot units.
• EN ISO 22675:2006 - the European adoption that is modified by this draft amendment.
• ISO 10328 - referenced in the amendment for related resultant reference forces and compatibility of test procedures.

For implementers, review the draft amendment text, Annex C (now normative), and the updated tables to ensure test rigs, end attachments and force prescriptions match the revised requirements before issuing test reports or declaring conformity.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 22675:2006/oprA1:2012
01-januar-2012
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO 22675:2006/DAM 1:2011)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO 22675:2006/DAM 1:2011)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO 22675:2006/DAM 1:2011)
Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO 22675:2006/DAM 1:2011)
Ta slovenski standard je istoveten z: EN ISO 22675:2006/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 22675:2006/oprA1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 22675:2006/oprA1:2012

SIST EN ISO 22675:2006/oprA1:2012

EUROPEAN STANDARD
DRAFT
EN ISO 22675:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
October 2011
ICS 11.040.40
English Version
Prosthetics - Testing of ankle-foot devices and foot units -
Requirements and test methods (ISO 22675:2006/DAM 1:2011)
Prothèses - Essais d'articulations cheville-pied et unités de Prothetik - Prüfung von Knöchel-Fuß-Passteilen und
pied - Exigences et méthodes d'essai (ISO Fußeinheiten - Anforderungen und Prüfverfahren (ISO
22675:2006/DAM 1:2011) 22675:2006/DAM 1:2011)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 293.

This draft amendment A1, if approved, will modify the European Standard EN ISO 22675:2006. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22675:2006/prA1:2011: E
worldwide for CEN national Members.

SIST EN ISO 22675:2006/oprA1:2012
EN ISO 22675:2006/prA1:2011 (E)
Contents Page
Foreword .3

SIST EN ISO 22675:2006/oprA1:2012
EN ISO 22675:2006/prA1:2011 (E)
Foreword
This document (EN ISO 22675:2006/prA1:2011) 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO 22675:2006/DAM 1:2011 has been approved by CEN as a EN ISO 22675:2006/prA1:2011
without any modification.
SIST EN ISO 22675:2006/oprA1:2012

SIST EN ISO 22675:2006/oprA1:2012

DRAFT AMENDMENT ISO 22675:2006/DAM 1
ISO/TC 168 Secretariat: DIN
Voting begins on Voting terminates on

2011-10-27 2012-03-27
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION

Prosthetics — Testing of ankle-foot devices and foot units —
Requirements and test methods
AMENDMENT 1
Prothèses — Essais d'articulations cheville-pied et unités de pied — Exigences et méthodes d'essai
AMENDEMENT 1
ICS 11.040.40
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2011

SIST EN ISO 22675:2006/oprA1:2012
ISO 22675:2006/DAM 1
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
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ii © ISO 2011 – All rights reserved

SIST EN ISO 22675:2006/oprA1:2012
ISO 22675:2006/DAM 1
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
Amendment 1 to ISO 22675:2006 was prepared by Technical Committee ISO/TC 168, Prosthetics and
orthotics and by Technical Committee CEN/TC 293, Assistive products for persons with diasbility in
collaboration.
SIST EN ISO 22675:2006/oprA1:2012

SIST EN ISO 22675:2006/oprA1:2012
DRAFT AMENDMENT ISO 22675:2006/DAM 1

Prosthetics — Testing of ankle-foot devices and foot units —
Requirements and test methods
AMENDMENT 1
Page 8, 7.2.3
Replace 7.2.3 with the following text:
Test loading levels: P3, P4, P5, P6, P7 and P8
NOTE 1 Field experience has shown that there is a need for lower limb prostheses which sustain loads above the level
covered by test loading level P5. In order to allow the structural testing of such prostheses on a uniform basis, test loading
levels P6, P7 and P8 have been developed for the principal structural tests and the separate structural tests on ankle-foot
devices and foot units (see Annex C).
NOTE 2 The values of the dimensions and loads of test loading levels P3, P4 and P5 are specified in separate tables
in Clause 8. It is suggested that the values of the dimensions and loads specified in C.3 and Table C.2 are appropriate for
test loading level P6 and as an interim measure, pending validation, P7 and P8. Further test loading levels will be defined,
if necessary.
Page 10, Table 5
Delete the NOTE and replace by the following:
For the additional test loading levels P6, P7 and P8 the test forces are specified in Table C.1.
Page 11, Table 6
Delete the NOTE and replace by the following:
The total length and the segmental lengths also apply to the additional test loading levels P6, P7 and P8
specified in Annex C [see C.3 a)].
Page 12, Table 7
Delete the NOTE and replace b
...