BS EN ISO 17730-2014 Dentistry Fluoride varnishes《牙科 含氟涂料》.pdf
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1、BSI Standards PublicationBS EN ISO 17730:2014Dentistry Fluoride varnishesBS EN ISO 17730:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17730:2014.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene product
2、s.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI Standa
3、rdsLimited 2014ISBN 978 0 580 78987 8ICS 97.170Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2014.Amendments issued since publicationDate Text affect
4、edEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17730 November 2014 ICS 97.170 English Version Dentistry - Fluoride varnishes (ISO 17730:2014) Mdecine bucco-dentaire - Vernis fluors (ISO 17730:2014) Zahnheilkunde - Fluoridlacke (ISO 17730:2014) This European Standard was approved by CEN o
5、n 23 August 2014. 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 ma
6、y be obtained on application to the 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
7、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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland
8、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Manageme
9、nt Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17730:2014 EBS EN ISO 17730:2014EN ISO 17730:2014 (E) 3 Foreword This document (EN ISO 17730:2014) has been prepared by Technical
10、 Committee ISO/TC 106 “Dentistry” in collaboration with 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 May 2015,
11、 and conflicting national standards shall be withdrawn at the latest by May 2015. 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. Acco
12、rding 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, Former Yugoslav Republic of Macedonia, France, Germany
13、, 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 17730:2014 has been approved by CEN as EN ISO 17730:2014
14、 without any modification. BS EN ISO 17730:2014ISO 17730:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and Definitions 14 Requirements 24.1 Total fluoride content 25 Sampling 26 Test method . 26.1 Test for total fluoride content 26.2 Test conditions 37 Test
15、report . 48 Instructions for use . 49 Packaging, labelling, and marking . 59.1 Packaging . 59.2 Labelling . 5Bibliography 6 ISO 2014 All rights reserved iiiBS EN ISO 17730:2014ISO 17730:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national stan
16、dards 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 org
17、anizations, 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.The procedures used to develop this document and those intended for its
18、 further maintenance 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/dir
19、ectives).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. Details of any patent rights identified during the development of the document will be in th
20、e Introduction 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 relate
21、d to conformity 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 information .The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC7, Oral care products
22、.iv ISO 2014 All rights reservedBS EN ISO 17730:2014ISO 17730:2014(E)IntroductionFluoride varnishes are used in dentistry primarily for caries prevention and reduction of dentine hypersensitivity. Fluoride varnishes are applied in the oral cavity directly on the outer surfaces of teeth and fillings,
23、 and are intended to remain at least for several hours.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this International Standard, but it is recommended that, for the assessment of possible biological or toxicologi
24、cal hazards, reference should be made to ISO 10993-1 and ISO 7405. ISO 2014 All rights reserved vBS EN ISO 17730:2014BS EN ISO 17730:2014Dentistry Fluoride varnishes1 ScopeThis International Standard specifies requirements and their test methods for total digestible fluoride content in dental varnis
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