EN ISO 16409-2016 en Dentistry - Oral care products - Manual interdental brushes《牙科口腔护理产品-人工牙间刷(ISO 16409 2016)》.pdf

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1、BS EN ISO 16409:2016Dentistry Oral care products Manual interdental brushes(ISO 16409:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 16409:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 16409:2016. It su

2、persedes BS EN ISO 16409:2006+A1:2010 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to

3、 include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 86092 8 ICS 97.170 Compliance with a British Standard cannot confer immunity from legal obligations.Thi

4、s British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16409 November 2016 ICS 97.170 Supersedes EN ISO

5、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) Zahnheilkunde - Mundhygieneprodukte - Manuelle Interdentalbrsten (ISO 16409:2016) This

6、 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 national standard without any alteration. Up-to-date lists and bibliographical referenc

7、es 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). A version in any other language made by translation under the responsibility of a CEN me

8、mber 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, F

9、rance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES

10、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 16409:2016 EBS EN ISO 16409:2016EN ISO 16409:2016 (E) 3 European foreword This document (E

11、N 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 of an identical te

12、xt 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 held responsible for

13、 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, Croatia, Cyprus, Czech

14、 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 the United Kingdom.

15、 Endorsement notice The text of ISO 16409:2016 has been approved by CEN as EN ISO 16409:2016 without any modification. BS EN ISO 16409:2016ISO 16409:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 Defects or contamin

16、ation . 25.2 Brush size 25.3 Filament retention . 35.4 Stem retention . 35.5 Stem durability 36 Sampling 37 Test methods . 37.1 General . 37.2 Pass/fail criteria . 37.3 Visual inspection . 37.4 Passage hole diameter 37.4.1 Apparatus . 37.4.2 Procedure . 47.4.3 Evaluation 57.5 Filament retention . 67

17、.5.1 Apparatus . 67.5.2 Procedure . 67.5.3 Evaluation 67.6 Stem retention . 67.6.1 Apparatus . 67.6.2 Procedure . 77.6.3 Evaluation 87.7 Stem durability 87.7.1 Apparatus . 87.7.2 Procedure 107.7.3 Evaluation . 118 Test report 119 Accompanying information 119.1 Manufacturers instructions for use 119.

18、2 Labelling on the package . 1110 Packaging 12 ISO 2016 All rights reserved iiiContents PageBS EN ISO 16409:2016ISO 16409:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internat

19、ional 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 organizations, governmental and non-governmental, in liaison with I

20、SO, 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 maintenance are described in the ISO/IEC Directives, Pa

21、rt 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).Attention is drawn to the possibility that some of the

22、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 Introduction and/or on the ISO list of patent declarations rec

23、eived (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 conformity assessment, as well as information about ISOs ad

24、herence 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 second edition cancels and replaces the first edition (I

25、SO 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 procedure for the passage hole diameter for cylindrical and ta

26、pered brush heads.It also incorporates the Amendment ISO 16409:2006/Amd 1:2010.iv ISO 2016 All rights reservedBS EN ISO 16409:2016ISO 16409:2016(E)IntroductionManual interdental brushes are used for oral hygiene purposes intended to provide health benefits. Their main application purpose is mechanic

27、al plaque removal, primarily from the interdental regions. ISO 2016 All rights reserved vBS EN ISO 16409:2016BS EN ISO 16409:2016Dentistry Oral care products Manual interdental brushes1 ScopeThis International Standard specifies requirements and test methods for performance criteria for manual inter

28、dental brushes with a round cross-section 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 Inter

29、national Standard is not applicable to powered 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

30、indispensable for its application. For dated 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 defi

31、nitions given in ISO 1942 and the following 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 s

32、paces between the teeth to clean the exposed 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

33、 manual interdental brush head (3.2), usually 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.INTERNATIONAL STANDARD ISO 16409:2016(E) ISO 2016 All rights reserved 1BS EN

34、ISO 16409:2016ISO 16409:2016(E)3.5filamentsingle strand, attached to the stem (3.4)3.6stem retention 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) c

35、an pass without stem (3.4) deformation3.8brush sizeindex of brush sizes determined by the passage hole 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 t

36、he handle; Type 3: the stem fulfils the function of a handle.5 Requirements5.1 Defects or contaminationManual 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 sha

37、ll be in accordance with Table 1.Table 1 Brush size of interdental brushesDimensions in millimetresBrush 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

38、 hole diameter in accordance with 7.42 ISO 2016 All rights reservedBS EN ISO 16409:2016ISO 16409:2016(E)5.3 Filament retentionThe 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

39、 withstand a removal force not less than 15 N.Test in accordance with 7.6.5.5 Stem durabilityThe stem of manual interdental 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 manu

40、factured manual interdental brushes and shall not be altered or adjusted in any way, except as needed to perform the tests.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

41、GeneralAll tests shall be conducted using dry interdental brushes at the temperature of (23 5) C and (50 10) % relative 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

42、meet the minimum requirement, test another eight interdental brushes. If no more manual interdental brushes fail, the product 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 ins

43、pectionVisual inspection shall be performed with normal visual acuity without magnification.7.4 Passage hole diameter7.4.1 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 ra

44、nging from 0,6 mm up to 3,5 mm ISO 2016 All rights reserved 3BS EN ISO 16409:2016ISO 16409:2016(E)in 0,1 mm increments and a total of 30 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

45、; 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 unobstruc

46、ted 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 with a clinically relevant force until the entire manual interdental brush head passes through the hole. Then, pull out the manual interdental brush head from the hole. Repea

47、t with all eight brush samples.7.4.2.2.2 Tapered brush headsInsert the manual interdental brush into the hole by hand with a clinically relevant force until the entire manual interdental brush head passes through the hole. Then, pull out the manual interdental brush head from the hole. Repeat with a

48、ll eight brush samples.As an option, in order to describe the taper of the brush, insert the manual interdental brush into the hole by hand with a clinically relevant force until the tip of the manual interdental brush head passes 4 ISO 2016 All rights reservedBS EN ISO 16409:2016ISO 16409:2016(E)th

49、rough the hole 1 mm beyond the surface of the measuring plate (see Figure 2). Then, pull out the manual interdental brush head from the hole. Repeat with all eight brush samples.Dimensions in millimetresKey1 measuring plate2 tapered brush head3 brush handleFigure 2 Procedure for tapered brush heads7.4.2.3 Step 3When all eight samples can be inserted and removed from the hole without stem deformation, the sample set is judged to pass that hole. Otherwise, the sample set is judged not to pass that hole.7.4.2.4 Step 4If