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EN ISO 10328:2006/FprA1

(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

Status
Not Published
Publication Date
06-Aug-2013
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
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
Completion Date
12-Jan-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
SIST EN ISO 10328:2006/kprA1:2013 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006/FDAM 1:2013)

Relations

Amends
EN ISO 10328:2006 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)
Effective Date
08-Jun-2022

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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.

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SIST EN ISO 10328:2006/oprA1:2012

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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.

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SIST EN ISO 10328:2006/oprA1:2012
EN ISO 10328:2006/prA1:2011 (E)
Contents Page
Foreword .3

2

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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

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SIST EN ISO 10328:2006/oprA1:2012

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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  
...

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