SVENSK STANDARD SS-EN ISO 13897:2005 Fastställd 2005-04-15 Utgåva 1 Tandvård Amalgamkapslar (ISO 13897:2003) Dentistry Amalgam capsules (ISO 13897:2003) ICS 11.060.10 Språk: engelska Publicerad: maj 2005 Copyright SIS. Reproduction in any form without permission is prohibited.
Europastandarden EN ISO 13897:2004 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 13897:2004. The European Standard EN ISO 13897:2004 has the status of a Swedish Standard. This document contains the official English version of EN ISO 13897:2004. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon 08-555 520 00. Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Postadress: SIS Förlag AB, 118 80 STOCKHOLM Telefon: 08-555 523 10. Telefax: 08-555 523 11 E-post: sis.sales@sis.se. Internet: www.sis.se
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 13897 May 2004 ICS 11.060.10 English version Dentistry - 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. 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 STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13897:2004 E
Page 2 EN ISO 13897:2004 Foreword The 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 taken over as EN ISO 13897:2004 by Technical Committee CEN/TC 55 "Dentistry", the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2004, and conflicting national standards shall be withdrawn at the latest by November 2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the 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 notice The text of ISO 13897:2003 has been approved by CEN as EN ISO 13897:2004 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative).
Page 3 EN ISO 13897:2004 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.
Page 4 EN ISO 13897:2004 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 capsules covered by this International Standard shall be classified as follows, according to the reusability of the mixing capsule: Type 1: predosed mixing capsule Type 2: reusable mixing capsule