EN ISO 6874-2015 en Dentistry - Polymer-based pit and fissure sealants《牙科 聚合物凹陷和齿面裂沟封剂(ISO 6874 2015)》.pdf
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1、BSI Standards PublicationBS EN ISO 6874:2015Dentistry Polymer-based pitand fissure sealantsBS EN ISO 6874:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6874:2015.It supersedes BS EN ISO 6874:2005 which is withdrawn.The UK participation in its preparat
2、ion was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are respons
3、ible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 88297 5 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standar
4、ds Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6874 September 2015 ICS 11.060.10 Supersedes EN ISO 6874:2005English Version Dentistry - Polymer-based pit and fiss
5、ure sealants (ISO 6874:2015) Mdecine bucco-dentaire - Produits dentaires base de polymres pour comblement des puits et fissures (ISO 6874:2015) Zahnheilkunde - Versiegelungskunststoffe fr Grbchen und Fissuren (ISO 6874:2015) This European Standard was approved by CEN on 10 July 2015. CEN members are
6、 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 t
7、he CEN-CENELEC 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 CEN-CENELEC Management Cen
8、tre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuan
9、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-100
10、0 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6874:2015 EBS EN ISO 6874:2015EN ISO 6874:2015 (E) 3 European foreword This document (EN ISO 6874:2015) has been prepared by Technical Committee ISO/TC 106 “Dentis
11、try“in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held byDIN. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national stan
12、dards shallbe withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 687
13、4:2005. According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,France
14、, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 6874:2015 has been approved by CEN as EN ISO 6874
15、:2015 without any modification. BS EN ISO 6874:2015ISO 6874:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Classification 14 Requirements 14.1 Biocompatibility 14.2 Physical properties 14.2.1 Working time, Class 1 sealant . 14.2.2 Setting time, Class 1 sealant . 14.2.3 Depth of
16、 cure, Class 2 sealant . 15 Sampling 26 Test methods . 26.1 Inspection 26.2 Test conditions 26.3 Preparation of test specimens . 26.4 Working time, Class 1 sealant 26.4.1 Apparatus . 26.4.2 Procedure . 46.4.3 Treatment of results 46.5 Setting time, Class 1 sealant 56.5.1 Apparatus . 56.5.2 Procedure
17、 . 56.5.3 Treatment of results 56.6 Depth of cure, Class 2 sealant . 66.6.1 Apparatus . 66.6.2 Procedure . 66.6.3 Treatment of results 67 Packaging, marking and instructions and information to be supplied by the manufacturer . 67.1 Packaging . 77.2 Marking . 77.2.1 Capsule or single dose container .
18、 77.2.2 Outer pack . 77.3 Manufacturers instructions and information for the user . 7Bibliography 9 ISO 2015 All rights reserved iiiContents PageBS EN ISO 6874:2015ISO 6874:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
19、(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, g
20、overnmental 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.The procedures used to develop this document and those intended for its further main
21、tenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Atte
22、ntion 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. Details of any patent rights identified during the development of the document will be in the Introductio
23、n and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformi
24、ty assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC1, Filling and restorative materia
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