DIN EN ISO 16409-2017 Dentistry - Oral care products - Manual interdental brushes (ISO 16409 2016) German version EN ISO 16409 2016《牙科学 口腔护理产品 手动牙刷(ISO 16409-2016) 德文版本EN ISO 16409.pdf

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1、March 2017 English price group 11No 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).ICS 97.170!%bn“2637598www.din.deDIN EN

2、 ISO 16409Dentistry Oral care products Manual interdental brushes (ISO 16409:2016);English version EN ISO 16409:2016,English translation of DIN EN ISO 16409:2017-03Zahnheilkunde Mundhygieneprodukte Manuelle Interdentalbrsten (ISO 16409:2016);Englische Fassung EN ISO 16409:2016,Englische bersetzung v

3、on DIN EN ISO 16409:2017-03Mdecine buccodentaire Produits de soins buccodentaires Brosses interdentaires manuelles (ISO 16409:2016);Version anglaise EN ISO 16409:2016,Traduction anglaise de DIN EN ISO 16409:2017-03SupersedesDIN EN ISO 16409:201006www.beuth.deDocument comprises 19 pagesDTranslation b

4、y DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 16409:2017-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16409:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collabo

5、ration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-19 AA Mundpflegeprodukte. The DIN Standard corresponding to the I

6、nternational Standard referred to in Clause 2 of this standard is as follows: ISO 1942 DIN EN ISO 1942 Amendments This standard differs from DIN EN ISO 16409:2010-06 as follows: a) the bigger brush size 8 has been added in Table 1; b) in Clause 6, the number of test samples (eight manual interdental

7、 brushes) has been specified; c) the measuring procedure for the passage hole diameter for cylindrical and tapered brush heads has been clarified. Previous editions DIN EN ISO 16409: 2007-01, 2010-06 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary EUROPEAN STANDARD

8、 NORME EUROPENNE EUROPISCHE NORM EN ISO 16409 November 2016 ICS 97.170 Supersedes EN ISO 16409:2006English Version Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016) Mdecine bucco-dentaire - Produits de soins bucco-dentaires - Brosses interdentaires manuelles(ISO 16409:2016

9、) Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbrsten (ISO 16409:2016) This European Standard was approved by CEN on 14 August 2016. 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

10、 national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may 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).

11、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 Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyp

12、rus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kin

13、gdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16

14、409:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Classification 75 Requirements 75.1 Defects or contamination . 75.2 Brush size 75.3 Filament retention . 85.4 Stem retention . 85.5 Stem durability 86 Sampling 87 Test methods . 87.1 General .

15、 87.2 Pass/fail criteria . 87.3 Visual inspection . 87.4 Passage hole diameter 87.4.1 Apparatus . 87.4.2 Procedure . 97.4.3 Evaluation . 107.5 Filament retention 117.5.1 Apparatus 117.5.2 Procedure 117.5.3 Evaluation . 117.6 Stem retention 117.6.1 Apparatus 117.6.2 Procedure 127.6.3 Evaluation . 137

16、.7 Stem durability. 137.7.1 Apparatus 137.7.2 Procedure 157.7.3 Evaluation .168 Test report 169 Accompanying information 169.1 Manufacturers instructions for use 169.2 Labelling on the package . 1610 Packaging 17Contents PageDIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E) 2Foreword .4European forewor

17、d This document (EN ISO 16409:2016) has 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

18、of an identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. 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 he

19、ld responsible for identifying any or all such patent rights. This document supersedes EN ISO 16409:2006. 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, Croa

20、tia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and t

21、he United Kingdom. Endorsement notice The text of ISO 16409:2016 has been approved by CEN as EN ISO 16409:2016 without any modification. DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bo

22、dies (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 organizatio

23、ns, 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 further

24、 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/directives)

25、.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 the Introd

26、uction 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 con

27、formity 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 SC 7, Oral care products.This

28、second edition cancels and replaces the first edition (ISO 16409:2006), which has been technically revised with the following changes: addition of bigger brush size 8 in Table 1; specification of number of test samples (eight manual interdental brushes) in Clause 6; clarification of measuring proced

29、ure for the passage hole diameter for cylindrical and tapered brush heads.It also incorporates the Amendment ISO 16409:2006/Amd 1:2010.DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E) 4 IntroductionManual interdental brushes are used for oral hygiene purposes intended to provide health benefits. Their

30、 main application purpose is mechanical plaque removal, primarily from the interdental regions.DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E)5 1 ScopeThis International Standard specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section

31、 of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturers instructions for use and labelling of the packaging.Excluded are interdental brushes with a plastic core.This International Standard is not applicable to po

32、wered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For da

33、ted references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the followi

34、ng apply.3.1manual interdental brushhand-powered device composed of filaments (3.5) emanating radially from a stem (3.4) intended for cleaning of interdental surfaces3.2interdental brush headpart of manual interdental brush (3.1), which passes in and out of spaces between the teeth to clean the expo

35、sed surfacesNote 1 to entry: The brush head may be fixed or removable, but is fixed during use.3.3interdental brush handlepart of manual interdental brush (3.1), which holds the stem (3.4) of the manual interdental brush3.4stemcentral support structure of the manual interdental brush head (3.2), usu

36、ally composed of twisted wire, which secures the filaments (3.5)Note 1 to entry: The stem is either secured in the handle, in a connector, or fulfils the function of a handle itself.DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E) 6 3.5filamentsingle strand, attached to the stem (3.4)3.6stem retention

37、 forceforce required to remove the stem (3.4) from the interdental brush handle (3.3) holding it3.7passage hole diameterminimum diameter of a hole through which a manual interdental brush head (3.2) can pass without stem (3.4) deformation3.8brush sizeindex of brush sizes determined by the passage ho

38、le diameter (3.7)4 ClassificationManual interdental brushes shall be classified as follows: Type 1: replacement heads may be mounted into a handle; Type 2: the brush head is permanently affixed into the handle; Type 3: the stem fulfils the function of a handle.5 Requirements5.1 Defects or contaminat

39、ionManual interdental brushes including all supplied parts shall be free of apparent defects or contamination.Test in accordance with 7.3.5.2 Brush sizeThe brush size of manual interdental brushes shall be in accordance with Table 1.Table 1 Brush size of interdental brushesDimensions in millimetresB

40、rush size Passage hole diameter0 0,61 0,7 to 0,82 0,9 to 1,03 1,1 to 1,24 1,3 to 1,55 1,6 to 1,86 1,9 to 2,37 2,4 to 2,88 2,9Determine the brush size of a manual interdental brush by using the passage hole diameter in accordance with 7.4DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E)7 5.3 Filament re

41、tentionThe filaments of manual interdental brushes shall not come off.Test in accordance with 7.5.5.4 Stem retentionThe stem of manual interdental brushes of Type 1 and Type 2 shall withstand a removal force not less than 15 N.Test in accordance with 7.6.5.5 Stem durabilityThe stem of manual interde

42、ntal brushes shall withstand the repeated bending for 20 cycles.Test in accordance with 7.7.6 SamplingThe manual interdental brushes used for testing shall be representative of manufactured manual interdental brushes and shall not be altered or adjusted in any way, except as needed to perform the te

43、sts.Eight interdental brushes of each type shall be evaluated in each test. If it is necessary to repeat a test, another eight interdental brushes shall be tested.7 Test methods7.1 GeneralAll tests shall be conducted using dry interdental brushes at the temperature of (23 5) C and (50 10) % relative

44、 humidity.7.2 Pass/fail criteriaFor the filament retention, stem retention and stem durability tests, if none fail, the product set passes. If one manual interdental brush does not meet the minimum requirement, test another eight interdental brushes. If no more manual interdental brushes fail, the p

45、roduct passes. If a total of two or more manual interdental brushes of the sixteen fail, the product fails.For the determination of the passage hole diameter, see 7.4.7.3 Visual inspectionVisual inspection shall be performed with normal visual acuity without magnification.7.4 Passage hole diameter7.

46、4.1 Apparatus7.4.1.1 Measuring plate, made of stainless steel or hardened steel with a thickness of (2,0 0,1) mm. The measuring plate has holes without sharp edges with diameters ranging from 0,6 mm up to 3,5 mm DIN EN ISO 16409:2017-03 EN ISO 16409:2016 (E) 8 in 0,1 mm increments and a total of 30

47、holes (see Figure 1). Tolerance of diameters of holes shall be from 0,02 mm to +0,02 mm.NOTE The design of the manual interdental brush head is given as an example; other designs are also possible.Figure 1 Measuring plate for the determination of passage hole diameter showing seven holes of the indicated 30 holes7.4.2 Procedure7.4.2.1 Step 1Select a hole on the measuring plate (7.4.1.1) such that the manual interdental brush head is expected to pass unobstructed through the hole.7.4.2.2 Step 27.4.2.2.1 Cylindrical brush headsInsert the manual interdental brush into the hole by hand