SIST EN ISO 10328:2006/kprA1:2013
(Amendment)Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006/FDAM 1:2013)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006/FDAM 1:2013)
2015-11-30: Project cancelled in ISO, awaiting BT decision to cancel CEN projec (notification to dataservice 215-11-12).
2012-12-13 GVN: Draft for // vote received at ISO/CS (see notification in dataservice on 2012-12-12)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen und Prüfverfahren (ISO 10328:2006/FDAM 1:2013)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs - Exigences et méthodes d'essai (ISO 10328:2006/FDAM 1:2013)
Protetika - Preskušanje strukture protez spodnjih okončin - Zahteve in preskusne metode - Dopolnilo A1 (ISO 10328:2006/FDAM 1:2013)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10328:2006/oprA1:2012
01-januar-2012
3URWHWLND3UHVNXãDQMHVWUXNWXUHSURWH]VSRGQMLKRNRQþLQ=DKWHYHLQSUHVNXVQH
PHWRGH ,62 '$0
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO 10328:2006/DAM 1:2011)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO 10328:2006/DAM 1:2011)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs -
Exigences et méthodes d'essai (ISO 10328:2006/DAM 1:2011)
Ta slovenski standard je istoveten z: EN ISO 10328:2006/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 10328:2006/oprA1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
---------------------- Page: 2 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
EUROPEAN STANDARD
DRAFT
EN ISO 10328:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
October 2011
ICS 11.040.40
English Version
Prosthetics - Structural testing of lower-limb prostheses -
Requirements and test methods (ISO 10328:2006/DAM 1:2011)
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/DAM 1:2011) 10328:2006/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 10328:2006. 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 10328:2006/prA1:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
EN ISO 10328:2006/prA1:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
EN ISO 10328:2006/prA1:2011 (E)
Foreword
This document (EN ISO 10328:2006/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 10328:2006/DAM 1:2011 has been approved by CEN as a EN ISO 10328:2006/prA1:2011
without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
---------------------- Page: 6 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
DRAFT AMENDMENT ISO 10328:2006/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 — Structural testing of lower-limb prostheses —
Requirements and test methods
AMENDMENT 1
Prothèses — Essais portant sur la structure des prothèses de membres inférieurs — 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.
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
---------------------- Page: 7 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
ISO 10328:2006/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,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2011 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
ISO 10328:2006/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 10328:2006 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.
© ISO 2011 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
---------------------- Page: 10 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
DRAFT AMENDMENT ISO 10328:2006/DAM 1
Prosthetics — Structural testing of lower limb prostheses —
Requirements and test methods
AMENDMENT 1
Page 13, 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 D).
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 D.3 and D.4 and Tables D.2 and D.3
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 15, Table 4
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 D.1.
Page 15, Table 5
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 D [see D.3 a)].
Page 16, Table 6
Delete the NOTE and replace by the following:
The offsets specified for P5 also apply to the additional test loading levels P6, P7 and P8 specified in Annex D
[see D.3 a)].
Page 16, Table 7
Delete the NOTE and replace by the following:
The combined offsets specified for P5 also apply to the additional test loading levels P6, P7 and P8 specified
in Annex D.
© ISO 2011 – All rights reserved 1
---------------------- Page: 11 ----------------------
SIST EN ISO 10328:2006/oprA1:2012
ISO 10328:2006/DAM 1
Page 17, Table 8
Delete the NOTE and replace by the following:
For the additional test loading levels P6, P7 and P8 the values of the test forces and the prescribed number of
cycles are specified in Table D.2.
Page 18, Table 9
Delete the NOTE and replace by the following:
The specified test loads also apply to the additional test loading levels P6, P7 and P8 specified in Annex D.
Page 18, Table 10
Delete the NOTE and replace by the following:
The specified directions of loading also apply to the additional test loading levels P6, P7 and P8 specified in
Annex D.
Page 19, Table 11
Delete the NOTE and replace by the following:
For the additional test loading levels P6, P7 and P8 the values of the test forces and the prescribed number of
cycles are specified in Table D.3
Page 19, Table 12
Delete the NOTE and replace by the following:
The specified loading parameters also apply to the additional test loading levels P6, P7 and P8 specified in
Annex D.
Page 20, Table 13
Delete the NOTE and replace by the following:
The specified offsets also apply to the additional test loading levels P6, P7 and P8 specified in Annex D.
Pag
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.