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
25、ents or flavouring agents, shall be considered as part of the device. 4.1.2 Shape The integrated dental floss and handle shall not have any sharp surface or parts when examined according to 6.2 b), except when a part, if included, is designed and intended to be used as a toothpick. 4.2 Strength The
26、integrated dental floss and handle shall withstand the static load of 10 N for 10 s without a breakage of the floss or handle, and without a pull-out of the floss from the handle when determined in accordance with the test method specified in Annex A. 5 Sampling Obtain a sufficient number of test sp
27、ecimens which are identical to the marketed product to complete all the prescribed tests and any necessary repeat tests. 6 Test conditions and visual inspection 6.1 Test conditions Prepare and test all specimens at a temperature of (23 5) C. 6.2 Visual inspection a) Use visual inspection by normal a
28、cuity without magnification for determining compliance with 4.1.1, Clause 7 and Clause 8. b) Use visual inspection with 10 magnification for determining compliance with 4.1.2. 7 Packaging The packaging shall be such that it will neither contaminate nor permit contamination of the integrated dental f
29、loss and handle. EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 6 8 Accompanying information 8.1 Labelling of the package The package shall be labelled with the following information: a) trade name of the product; b) name and address of the manufacturer and/or responsible distributor; c) manufacture
30、rs tracking code. 8.2 Instructions for use The integrated dental floss and handle shall be supplied with instructions for use. EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 7 Annex A (normative) Determination of the strength of integrated dental floss and handles A.1 Principle The assessment of the
31、 compliance of the strength of integrated dental floss and handles is determined by this test method. A.2 Apparatus and material A.2.1 Clamping device capable of sufficiently clamping the specimen, such as that shown in Figure A.1. A.2.2 Vice, capable of holding the clamping device (A.2.1). A.2.3 Ho
32、ok, having a tensile strength of not less than 100 N, smooth surface and cross-sectional diameter (3,0 0,5) mm. NOTE Hooks with a sectional diameter smaller than 2,5 mm or with a rough surface, or with both, can cause a breakage of the dental floss due to the excess concentration of force at the jun
33、ction of the hook and the floss. A.2.4 String or chain, or both, rigid, and having a tensile strength of not less than 100 N. A.2.5 Weight, capable of producing a static loading force of (10,0 0,5) N including both the hook (A.2.3) and the string or chain, or both (A.2.4). A.2.6 Timer, accurate to 1
34、 s. A.2.7 Water, Grade 3 of ISO 3696 or equivalent. A.3 Procedure Perform the following procedure to determine the strength of each specimen. Test 10 specimens. (See Figure A.1 for the schematic alignment for the strength test.) a) Fix the clamping device (A.2.1) to the vice (A.2.2). Assemble the st
35、atic weight by connecting the weight (A.2.5), the string or chain, or both (A.2.4) and the hook (A.2.3). b) Immerse the specimen of the integrated dental floss and handle in water (A.2.7) at (37 2) C for (90100+) s. c) Immediately after the removal from water, remove excess water on the surface of t
36、he specimen while holding it by shaking the specimen twice with a sharp snap of the wrist, and clamp the specimen on the clamping device as follows. 1) The longitudinal axis of the floss of the specimen shall be horizontal at least on the start of the test. 2) The circumferential surface of the lowe
37、r supporting washer(s) (Item 6) shall be attached to the lower surface of the handle of the specimen at the centre of the user-gripping area. The surfaces of the pads (Item 7) which face the handle shall press up against the respective surfaces of the handle, including the centre of the user-grippin
38、g area of the handle supporting the specimen. The EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 8 user-gripping area shall be specified according to the shape of the handle, or according to the manufacturers instructions for use. Otherwise, the centre of an assumed user-gripping area of the handle
39、shall be (30 1) mm horizontally apart from the centre of the retaining points of the floss with the handle. 3) The upper supporting washer(s) (Item 2) shall be positioned so as the circumferential surface(s) of the washer(s) to attach to the upper surface of the handle appropriately apart from the l
40、ower supporting washer(s) (Item 6) according to the shape and length of the handle. d) Align the static weight see A.3 a) in the fully stretched position before loading. At (6005) s after finishing the immersion, hang the hook at the centre of the length of the floss, then start loading by carefully
41、 removing the supporting device or operators hand from under the weight, and without imparting an unintended or sudden increase in force, start the timer (A.2.6) and keep loading for (1010+) s. e) After the removal of the weight, inspect the specimen to determine whether a breakage of the floss or h
42、andle or a pull-out of the floss from the handle has occurred. A.4 Treatment of results A.4.1 Pass-fail criteria For each specimen tested, express the results as either: a) pass, if the floss neither pulls out of the handle nor breaks, and the floss and handle does not break; or b) fail, if the cond
43、itions given in a) are not met. A.4.2 Compliance with the requirement Compliance with the requirement of 4.2 can be claimed as follows. a) Yes: if 8 or more of the 10 specimens pass the test, the integrated dental floss and handle complies with the requirement of 4.2. b) No: if fewer than 7 of the 1
44、0 specimens pass the test, the integrated dental floss and handle do not comply with the requirement of 4.2. c) Repeat the whole test: if 7 of the 10 specimens pass the test, repeat the test (A.3) with 10 new integrated dental floss and handles. Interpret the results in accordance with Table A.1. Ta
45、ble A.1 Treatment of results Test Number of specimens passing the test see A.4.1 a) Compliance with the requirement of 4.2 8 to 10 Yes 7 Repeat the whole test (10 new specimens) First test 0 to 6 No First Second Total Compliance with the requirement of 4.2 9 to 10 16 to 17 Yes First test + second (r
46、epeat) test 7 0 to 8 7 to 15 No EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 9 d1 d2Key 1 base plates 10 hook 2 upper supporting washers 11 string or chain, or both 3 upper clamping pads 12 weight 4 upper clamping plates 13 support for the weight until the loading starts 5 handle segment of the pr
47、oduct l1horizontal distance 6 lower supporting washers l2horizontal distance 7 lower clamping pads d1diameter of lower supporting washer (5 mm to 10 mm) 8 lower clamping plates d2diameter of upper supporting washer (5 mm to 30 mm) 9 dental floss segment aSlightly thinner than the thickness of the fl
48、oss handle at the place to be clamped.bClamp vertical sides of the floss handle. In the case of the upper clamping pads, it shall be used only if applicable according to the shape and size of the product. cPlace at outer-sides of clamping pads. In the case of the upper clamping plates, it shall be u
49、sed only if applicable according to the shape and size of the product.dAccording to the instructions for use, or to the size and shape of the product, otherwise 30 1 mm. eAccording to the shape and size of the product. Figure A.1 Schematic alignment for the strength test EN ISO 28158:2010 (E) DIN EN ISO 28158:2010-12 10 Bibliography 1 ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry 2 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk m
