BS EN ISO 28158-2010 Dentistry - Integrated dental floss and handles《牙科学 整合牙线和牙线柄》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 28158:2010Dentistry Integrateddental floss and handles (ISO28158:2010)BS EN ISO 28158:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementati

2、on of EN ISO28158:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene products.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

3、 of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 59601 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 31 July 2

4、010Amendments issued since publicationDate Text affectedEUROPEAN 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) Zahnh

5、eilkunde - Vorgespannte Zahnseiden mit Griff (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 withou

6、t any alteration. 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 m

7、ade by translation 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, Fi

8、nland, France, Germany, 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

9、 KOMITEE FR NORMUNG 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: EBS EN ISO 28158:2010EN ISO 28158:2010 (E) 3 Foreword This document (EN ISO 28158:2010) h

10、as been prepared by Technical 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 endorsemen

11、t, at the latest by January 2011, and conflicting national 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 identifyin

12、g any or all such patent rights. According 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, France, Germany,

13、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, 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

14、 any modification. BS EN ISO 28158:2010ISO 28158:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out

15、 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO col

16、laborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International S

17、tandards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements

18、 of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 28158 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products. BS EN ISO 28158:2010ISO 28158:2010(E) iv ISO 2010 All ri

19、ghts reservedIntroduction 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. BS EN ISO 28158:2010INTERNATION

20、AL STANDARD ISO 28158:2010(E) ISO 2010 All rights reserved 1Dentistry Integrated dental floss and handles 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

21、floss, or dental floss and handles to which the floss is subsequently added. This International 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

22、7405. 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 1942:2009, Denti

23、stry Vocabulary ISO 3696, Water for analytical laboratory use Specification and test 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 fil

24、ament or tape, commonly synthetic fibre, with or without coating material(s), designed 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.

25、2 integrated dental floss and handle oral hygiene device holding dental floss (3.1) as a fixed integral part BS EN ISO 28158:2010ISO 28158:2010(E) 2 ISO 2010 All rights reserved4 Requirements 4.1 Material and shape 4.1.1 Material The dental floss and handle shall be free from extraneous matter when

26、examined according to 6.2 a). Materials intentionally added to dental floss or handle, such as wax, pigments 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)

27、, except when a part, if included, is designed and intended to be used as a toothpick. 4.2 Strength The 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 i

28、n accordance with the test method specified in Annex A. 5 Sampling Obtain a sufficient number of test specimens 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 tes

29、t all specimens at a temperature of (23 5) C. 6.2 Visual inspection a) Use visual inspection by normal acuity 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 pack

30、aging shall be such that it will neither contaminate nor permit contamination of the integrated dental floss and handle. BS EN ISO 28158:2010ISO 28158:2010(E) ISO 2010 All rights reserved 38 Accompanying information 8.1 Labelling of the package The package shall be labelled with the following inform

31、ation: a) trade name of the product; b) name and address of the manufacturer and/or responsible distributor; c) manufacturers tracking code. 8.2 Instructions for use The integrated dental floss and handle shall be supplied with instructions for use. BS EN ISO 28158:2010ISO 28158:2010(E) 4 ISO 2010 A

32、ll rights reservedAnnex A (normative) Determination of the strength of integrated dental floss and handles A.1 Principle The assessment of the 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

33、 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 Hook, 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 t

34、han 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 junction 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 produci

35、ng 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 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 specimen

36、s. (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 static 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 flos

37、s 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 the 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 lo

38、ngitudinal axis of the floss of the specimen shall be horizontal at least on the start of the test. 2) The circumferential surface of the lower 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

39、the pads (Item 7) which face the handle shall press up against the respective surfaces of the handle, including the centre of the user-gripping area of the handle supporting the specimen. The BS EN ISO 28158:2010ISO 28158:2010(E) ISO 2010 All rights reserved 5user-gripping area shall be specified ac

40、cording 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 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(

41、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 lower 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 stre

42、tched 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 removing the supporting device or operators hand from under the weight, and without imparting an unintended or sudden increase in force, s

43、tart 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 handle 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,

44、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 conditions 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)

45、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 10 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

46、 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. Table 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 Re

47、peat 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 (repeat) test 7 0 to 8 7 to 15 No BS EN ISO 28158:2010ISO 28158:2010(E) 6 ISO 2010 All rights reservedd1 d2Key 1 base plates 10 hook 2 upper

48、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 product l1horizontal distance 6 lower supporting washers l2horizontal distance 7 lower clamping pads d1diameter of lower s

49、upporting 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 floss 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 used only if applicable according to the sha