DIN EN ISO 28158-2010 Dentistry - Integrated dental floss and handles (ISO 28158 2010) German version EN ISO 28158 2010《牙科学 整合牙线和牙线柄(ISO 28158-2010) 德文版本EN ISO 28158-2010》.pdf
《DIN EN ISO 28158-2010 Dentistry - Integrated dental floss and handles (ISO 28158 2010) German version EN ISO 28158 2010《牙科学 整合牙线和牙线柄(ISO 28158-2010) 德文版本EN ISO 28158-2010》.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 28158-2010 Dentistry - Integrated dental floss and handles (ISO 28158 2010) German version EN ISO 28158 2010《牙科学 整合牙线和牙线柄(ISO 28158-2010) 德文版本EN ISO 28158-2010》.pdf(13页珍藏版)》请在麦多课文档分享上搜索。
1、December 2010 Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 97.170!$lK“1735940www.din.deDDIN EN ISO 28158Dentistry Integrated dental floss and handles (ISO 28158:2010)English translation of DIN EN ISO 28158:2010-12Zahnheilkunde Zahnseide im Halter (ISO 28158:2010)Englische bersetzung von DIN EN ISO 28158:2010-12Mdecine bucco-dentaire Porte-fil et fil denta
3、ire intgr (ISO 28158:2010)Traduction anglaise de DIN EN ISO 28158:2010-12www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1312.10 DIN EN ISO 28158:2010-12 2 A comma is used as the decimal marker. National foreword This standard has
4、been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00
5、-19 AA Mundpflegeprodukte. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN ISO 3696, Water fo
6、r analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 28158 July 2010 ICS 97.170 English Version Dentistry Integrated dental floss and handles (ISO 28158:2010) Mdecine bucco-dentaire Porte-fil et fil dentaire intgr (ISO 28158:2010) Zahnhe
7、ilkunde Zahnseide im Halter (ISO 28158:2010) This European Standard was approved by CEN on 9 June 2010. 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.
8、 Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN 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 translatio
9、n 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, Ge
10、rmany, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMU
11、NG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28158:2010: EContents EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 2 Page Foreword3 Introduction .4 1 Scope 5 2 Norm
12、ative references 5 3 Terms and definitions .5 4 Requirements.6 4.1 Material and shape.6 4.2 Strength 6 5 Sampling.6 6 Test conditions and visual inspection.6 6.1 Test conditions 6 6.2 Visual inspection .6 7 Packaging .6 8 Accompanying information 7 8.1 Labelling of the package.7 8.2 Instructions for
13、 use .7 Annex A (normative) Determination of the strength of integrated dental floss and handles .8 A.1 Principle8 A.2 Apparatus and material.8 A.3 Procedure .8 A.4 Treatment of results 9 Bibliography 11 Foreword This document (EN ISO 28158:2010) has been prepared by Technical Committee ISO/TC 106 “
14、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 January 2011, and conflicting na
15、tional standards shall be withdrawn at the latest by January 2011. 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 CE
16、N/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, Li
17、thuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 28158:2010 has been approved by CEN as a EN ISO 28158:2010 without any modification. EN ISO 28158:2010 (E) DIN EN ISO
18、28158:2010-12 3 Introduction This International Standard has been prepared in order to present the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or as a part of dental treatment. EN ISO 28158:2010 (E) DIN EN
19、 ISO 28158:2010-12 4 1 Scope This International Standard is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or dental floss and handles to which the floss is subsequently added. This Int
20、ernational Standard does not specify specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405. 2 Normative references The following referenced documents are indispensable for
21、 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 1942:2009, Dentistry Vocabulary ISO 3696, Water for analytical laboratory use Specification and test
22、methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 dental floss multiple filaments gathered into thread, spun yarn, single filament or tape, commonly synthetic fibre, with or without coating material(s), designe
23、d for the removal of plaque or debris, or both, from the proximal surfaces of natural or artificial teeth and the gingival surfaces of pontics of fixed prostheses NOTE Adapted from ISO 1942:2009, definition 2.69. 3.2 integrated dental floss and handle oral hygiene device holding dental floss (3.1) a
24、s a fixed integral part EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 5 4 Requirements 4.1 Material and shape 4.1.1 Material The dental floss and handle shall be free from extraneous matter when examined according to 6.2 a). Materials intentionally added to dental floss or handle, such as wax, pigm
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