EN ISO 24234:2004/A1:2011
(Amendment)Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for marking and manufacturer's instructions concerning mercury (ISO 24234:2004/A1:2011)
Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for marking and manufacturer's instructions concerning mercury (ISO 24234:2004/A1:2011)
2010-11-24 EMA: // final draft provided to ISO/CS according to notification received in dataservice on 2010-11-22.
Zahnheilkunde - Quecksilber und Legierungen für zahnärztliche Amalgame - Änderung 1: Anforderungen an die Kennzeichnung und Gebrauchsanweisung des Herstellers bezüglich Quecksilber (ISO 24234:2004/A1:2011)
Art dentaire - Mercure et alliages pour amalgame dentaire - Amendement 1: Exigences quant au marquage et aux instructions du fabricant, concernant le mercure (ISO 24234:2004/A1:2011)
Zobozdravstvo - Živo srebro in zlitine za zobni amalgam - Dopolnilo 1: Zahteve za označevanje in navodila proizvajalca v zvezi z uporabo živega srebra (ISO 24234:2004/A1:2011)
Ta mednarodni standard določa zahteve in preskusne metode za zlitine in živo srebro, primerne za pripravo zobnega amalgama, skupaj z zahtevami in preskusnimi metodami za ta amalgam ter zahtevami za pakiranje in označevanje. Velja za zlitine, ki se dobavljajo v obliki praška v razsutem stanju, praška, stisnjenega v tableto, ali praška v predodmerjenih kapsulah. Velja za živo srebro za zobozdravstvo, ki se dobavlja v razsutem stanju, v predodmerjenih vrečkah ali predodmerjenih kapsulah. Ta mednarodni standard ne izključuje ločene dobave zlitine in živega srebra. Ta mednarodni standard ne velja za zlitine, ki se uporabljajo s tekočimi kovinami, ki niso živo srebro, in ne velja za tekoče kovinske zlitine.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 24234:2005/oprA1:2010
01-april-2010
Zobozdravstvo - Živo srebro in zlitine za zobni amalgam - Dopolnilo 1 (ISO
24234:2004/DAM 1:2010)
Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for
marking and manufacturer's instructions concerning mercury (ISO 24234:2004/DAM
1:2010)
Zahnheilkunde - Quecksilber und Legierungen für zahnärztliche Amalgame, Änderung 1
(ISO 24234:2004/DAM 1:2010)
Art dentaire - Mercure et alliages pour amalgame dentaire - Amendement 1: Exigences
quant au marquage et aux instructions du fabricant, concernant le mercure (ISO
24234:2004/DAM 1:2010)
Ta slovenski standard je istoveten z: EN ISO 24234:2004/prA1
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 24234:2005/oprA1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 24234:2005/oprA1:2010
SIST EN ISO 24234:2005/oprA1:2010
EUROPEAN STANDARD
DRAFT
EN ISO 24234:2004
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2010
ICS 11.060.10
English Version
Dentistry - Mercury and alloys for dental amalgam - Amendment
1: Requirements for marking and manufacturer's instructions
concerning mercury (ISO 24234:2004/DAM 1:2010)
Art dentaire - Mercure et alliages pour amalgame dentaire - Zahnheilkunde - Quecksilber und Legierungen für
Amendement 1: Exigences quant au marquage et aux zahnärztliche Amalgame, Änderung 1 (ISO
instructions du fabricant, concernant le mercure (ISO 24234:2004/DAM 1:2010)
24234:2004/DAM 1:2010)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 55.
This draft amendment A1, if approved, will modify the European Standard EN ISO 24234:2004. 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 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24234:2004/prA1:2010: E
worldwide for CEN national Members.
SIST EN ISO 24234:2005/oprA1:2010
EN ISO 24234:2004/prA1:2010 (E)
Contents Page
Foreword .3
SIST EN ISO 24234:2005/oprA1:2010
EN ISO 24234:2004/prA1:2010 (E)
Foreword
This document (EN ISO 24234:2004/prA1:2010) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by
DIN.
This document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO 24234:2004/DAM 1:2010 has been approved by CEN as a EN ISO 24234:2004/prA1:2010
without any modification.
SIST EN ISO 24234:2005/oprA1:2010
SIST EN ISO 24234:2005/oprA1:2010
DRAFT AMENDMENT ISO 24234:2004/DAmd 1
ISO/TC 106/SC 1 Secretariat: SCC
Voting begins on: Voting terminates on:
2010-01-07 2010-06-07
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Dentistry — Mercury and alloys for dental amalgam
AMENDMENT 1: Requirements for marking and manufacturer's
instructions concerning mercury
Art dentaire — Mercure et alliages pour amalgame dentaire
AMENDEMENT 1: Exigences quant au marquage et aux instructions du fabricant, concernant le mercure
ICS 11.060.10
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, 2010
SIST EN ISO 24234:2005/oprA1:2010
ISO 24234:2004/DAmd 1
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...
SLOVENSKI STANDARD
01-december-2011
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Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for
marking and manufacturer's instructions concerning mercury (ISO 24234:2004/A1:2011)
Zahnheilkunde - Quecksilber und Legierungen für zahnärztliche Amalgame - Änderung
1: Anforderungen an die Kennzeichnung und Gebrauchsanweisung des Herstellers
bezüglich Quecksilber (ISO 24234:2004/A1:2011)
Art dentaire - Mercure et alliages pour amalgame dentaire - Amendement 1: Exigences
quant au marquage et aux instructions du fabricant, concernant le mercure (ISO
24234:2004/A1:2011)
Ta slovenski standard je istoveten z: EN ISO 24234:2004/A1:2011
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 24234:2004/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2011
ICS 11.060.10
English Version
Dentistry - Mercury and alloys for dental amalgam - Amendment
1: Requirements for marking and manufacturer's instructions
concerning mercury (ISO 24234:2004/A1:2011)
Art dentaire - Mercure et alliages pour amalgame dentaire - Zahnheilkunde - Quecksilber und Legierungen für
Amendement 1: Exigences quant au marquage et aux zahnärztliche Amalgame (ISO 24234:2004/A1:2011)
instructions du fabricant, concernant le mercure (ISO
24234:2004/A1:2011)
This amendment A1 modifies the European Standard EN ISO 24234:2004; it was approved by CEN on 13 August 2011.
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. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This amendment 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 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.
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 24234:2004/A1:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 24234:2004/A1:2011) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 24234:2004 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by February 2012, and
conflicting national standards shall be withdrawn at the latest by February 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 24234:2004/A1:2011 has been approved by CEN as a EN ISO 24234:2004/A1:2011 without
any modification.
INTERNATIONAL ISO
STANDARD 24234
First edition
2004-10-15
AMENDMENT 1
2011-08-15
Dentistry — Mercury and alloys for dental
amalgam
AMENDMENT 1: Requirements for marking
and manufacturer's instructions concerning
mercury
Art dentaire — Mercure et alliages pour amalgame dentaire
AMENDEMENT 1: Exigences quant au marquage et aux instructions du
fabricant, concernant le mercure
Reference number
ISO 24234:2004/Amd.1:2011(E)
©
ISO 2011
ISO 24234:2004/Amd.1:2011(E)
© ISO 2011
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ISO 24234:2004/Amd.1:2011(E)
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
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International Ele
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