SIST EN ISO 13897:2004
(Main)Dentistry - Amalgam capsules (ISO 13897:2003)
Dentistry - Amalgam capsules (ISO 13897:2003)
This standard specifies requirements and test methods for predosed capsules and for reusable capsules used for mixing dental amalgam alloys and mercury.
Zahnheilkunde - Amalgamkapseln (ISO 13897:2003)
Art dentaire - Capsules pour amalgame (ISO 13897:2003)
L'ISO 13897:2002 spécifie les exigences et les méthodes d'essai concernant les capsules prédosées et les capsules réutilisables utilisées pour mélanger les alliages pour amalgame dentaire avec le mercure.
Zobozdravstvo – Amalgamske kapsule (ISO 13897:2003)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zobozdravstvo – Amalgamske kapsule (ISO 13897:2003)Zahnheilkunde - Amalgamkapseln (ISO 13897:2003)Art dentaire - Capsules pour amalgame (ISO 13897:2003)Dentistry - Amalgam capsules (ISO 13897:2003)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN ISO 13897:2004SIST EN ISO 13897:2004en,fr,de01-november-2004SIST EN ISO 13897:2004SLOVENSKI
STANDARD
SIST EN ISO 13897:2004
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 13897May 2004ICS 11.060.10English versionDentistry - Amalgam capsules (ISO 13897:2003)Art dentaire - Capsules pour amalgame (ISO 13897:2003)Zahnheilkunde - Amalgamkapseln (ISO 13897:2003)This European Standard was approved by CEN on 1 April 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 13897:2004 ESIST EN ISO 13897:2004
EN ISO 13897:2004 (E)2ForewordThe text of ISO 13897:2003 has been prepared by Technical Committee ISO/TC 106"Dentistry” of the International Organization for Standardization (ISO) and has been takenover as EN ISO 13897:2004 by Technical Committee CEN/TC 55 "Dentistry", the secretariatof which is held by DIN.This European Standard shall be given the status of a national standard, either by publicationof an identical text or by endorsement, at the latest by November 2004, and conflictingnational standards shall be withdrawn at the latest by November 2004.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.Endorsement noticeThe text of ISO 13897:2003 has been approved by CEN as EN ISO 13897:2004 without anymodifications.NOTE
Normative references to International Standards are listed in Annex ZA (normative).SIST EN ISO 13897:2004
EN ISO 13897:2004 (E)3Annex ZA(normative)Normative references to international publicationswith their relevant European publicationsThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text and thepublications are listed hereafter. For dated references, subsequent amendments to or revisionsof any of these publications apply to this European Standard only when incorporated in it byamendment or revision. For undated references the latest edition of the publication referred toapplies (including amendments).NOTE Where an International Publication has been modified by common modifications,indicated by (mod.), the relevant EN/HD applies.PublicationYearTitleENYearISO 15591995Dental materials - Alloys for dentalamalgamEN ISO 15592001ISO 15601985Dentistry - Dental mercuryEN 215601991ISO 1942-21989Dental vocabulary - Part 2: DentalmaterialsEN 21942-21992ISO 74881991Dental amalgamatorsEN ISO 74881995ISO 86011988Data elements and interchangeformats - Information interchange -Representation of dates and timesEN 286011992SIST EN ISO 13897:2004
SIST EN ISO 13897:2004
Reference numberISO 13897:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO13897First edition2003-02-15Dentistry — Amalgam capsules Art dentaire — Capsules pour amalgame
SIST EN ISO 13897:2004
ISO 13897:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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© ISO 2003 — All rights reserved
SIST EN ISO 13897:2004
ISO 13897:2003(E) © ISO 2003 — All rights reserved
iii 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. ISO 13897 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. SIST EN ISO 13897:2004
ISO 13897:2003(E) iv
© ISO 2003 — All rights reserved Introduction In order to produce dental amalgam, electrically powered amalgamators as described in ISO 7488 are primarily used for mixing (trituration) of amalgam alloys with mercury. In many amalgamators, a removable capsule is used to contain the alloy and mercury. Although the capsule must be considered as part of the amalgamator when in use or under test, the requirements for capsules are not dealt with in ISO 7488. These requirements are the subject of this International Standard.
SIST EN ISO 13897:2004
INTERNATIONAL STANDARD ISO 13897:2003(E) © ISO 2003 — All rights reserved
1 Dentistry — Amalgam capsules 1 Scope This International Standard specifies requirements and test methods for predosed capsules and for reusable capsules used for mixing dental amalgam alloys and mercury. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1559:1995, Dental materials — Alloys for dental amalgam ISO 1560, Dental mercury ISO 1942-2, Dental vocabulary — Part 2: Dental materials ISO 7488:1991, Dental amalgamators ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1559, ISO 1942-2, ISO 7488 and the following apply. 3.1 predosed capsule single-use capsule supplied containing separated measured amounts of alloy powder and mercury in such a way that premature contact is prevented 3.2 self-activating capsule predosed capsule in which contact between the alloy powder and mercury occurs automatically during amalgamation 3.3 activation action that renders the contained alloy powder and mercury mixable 4 Classification Amalgam ca
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