EN ISO 22254-2005 en Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection《牙科 手控牙刷 毛刷部分耐弯曲性-1990》.pdf

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1、BRITISH STANDARDBS EN ISO 22254:2005Dentistry Manual toothbrushes Resistance of tufted portion to deflectionThe European Standard EN ISO 22254:2005 has the status of a British StandardICS 97.170g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38

2、g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 22254:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006ISBN 0 580 48480 7National forewordThis British Standard

3、is the official English language version of EN ISO 22254:2005. It is identical with ISO 22254:2005. Together with BS EN ISO 20126:2005, it supersedes BS 5757:1989 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106

4、/7, Oral hygiene products, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in t

5、he BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible

6、for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK inter

7、ests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 7 and a back cover.The BS

8、I copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22254August 2005ICS 97.170 Supersedes EN 28627:1990 English VersionDentistry - Manual toothbrushes

9、- Resistance of tufted portion todeflection (ISO 22254:2005)Art dentaire - Brosses dents manuelles - Rsistance ladflexion de la surface garnie (ISO 22254:2005)Zahnheilkunde - Handzahnbrsten - Biegefestigkeit derBesteckungsflche (ISO 22254:2005)This European Standard was approved by CEN on 8 August 2

10、005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on

11、 application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat h

12、as the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slov

13、akia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for

14、 CEN national Members.Ref. No. EN ISO 22254:2005: EForeword This document (EN ISO 22254:2005) 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 give

15、n the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2006, and conflicting national standards shall be withdrawn at the latest by February 2006. This document supersedes EN 28627:1990. According to the CEN/CENELEC Internal Regul

16、ations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No

17、rway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22254:2005 has been approved by CEN as EN ISO 22254:2005 without any modifications. EN ISO 22254:2005Reference numberISO 22254:2005(E)INTERNATIONAL STANDARD ISO22254First edi

18、tion2005-08-15Dentistry Manual toothbrushes Resistance of tufted portion to deflectionArt dentaire Brosses dents manuelles Rsistance la dflexion de la surface garnie EN ISO 22254:2005ii iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standar

19、ds bodies (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 organi

20、zations, 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. International Standards are drafted in accordance with the rules given in

21、 the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. 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 %

22、of the member bodies casting a vote. 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. ISO 22254 was prepared by Technical Committee ISO/TC 106, Dentis

23、try, Subcommittee SC 7, Oral care products. This first edition cancels and replaces ISO 8627:1987. EN ISO 22254:2005iv Introduction The stiffness of the tufted area of a manual toothbrush has been of great concern for both consumers and manufacturers. This International Standard provides a test meth

24、od for determining the resistance of the tufted portion to deflection, which could be used to derive a stiffness as described in Annex A. However, this International Standard does not cover stiffness of manual toothbrushes and its classification. For stiffness determination, the measurement of the t

25、ufted area is required, but the result of the measurement varies over a wide range depending on the method of the measurement and the shape of the tuft holes. Therefore, the tufted area and stiffness determinations are described in Annex A. Since the perception of stiffness differs amongst different

26、 countries, stiffness may be classified differently in each country. EN ISO 22254:20051Dentistry Manual toothbrushes Resistance of tufted portion to deflection 1 Scope This International Standard specifies a test method for determining the resistance of the tufted portion of manual toothbrushes to d

27、eflection. This International Standard is applicable to toothbrushes having a conventional, flat trim design and may not be applicable to toothbrushes with other designs. The results obtained with this International Standard may not correspond to consumer perceptions of the stiffness of toothbrush f

28、ilaments. 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 (all pa

29、rts), Dentistry Vocabulary ISO 3696:1987, 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 1942-1 to ISO 1942-5 and the following apply. 3.1 manual toothbrush hand-powered device prima

30、rily for cleaning surfaces of teeth, the working end of which carries filaments 3.2 brush head working end of a toothbrush to which the filaments are attached 3.3 filament single strand within the brush head 3.4 tuft group of filaments gathered together and attached to the brush head 3.5 tuft hole s

31、urface surface of the tuft holes, which can be convex, triangular or plane and which is limited by a peripheral tangent line to the outer tuft holes 3.6 tuft hole plane plane between the base of the tufts (where they meet the face of the brush) at the top of the brush head and the base of the tufts

32、at the bottom of the brush head EN ISO 22254:20052 a) Side view of brush head Key 1 tuft hole surface 2 top of brush head 3 bottom of brush head 4 tuft hole plane 5 tufted area b) Top view of brush head Key 1 tuft hole surface 4 tuft hole plane Figure 1 Tuft hole plane EN ISO 22254:20053c) After rem

33、oval of tufts Key 1 tuft hole surface 4 tuft hole plane 5 tufted area Figure 1 (continued) 3.7 tufted area linear projection of the tuft hole surface on to the tuft hole plane NOTE An alternative definition is: area surrounded by a peripheral tangent line to the outer tufts where they meet the tuft

34、hole plane. 3.8 brush neck part of the toothbrush which joins the brush head to the handle 3.9 resistance to deflection resisting force of the tufts to deflection under a force of 5 N, applied at right angles to the tuft hole plane 4 Sampling The toothbrushes obtained for testing shall be as-manufac

35、tured and not modified in any way, except as specified for this International Standard. Five brushes shall be tested. The sampling method and the means of procurement are not covered by this International Standard and should be subject to agreement between the interested parties. EN ISO 22254:20054

36、5.1 Apparatus 5.1.1 Test machine (see Figure 2), capable of measuring the resistance of the tufted portion to deflection, consisting of the following components: 5.1.1.1 Brushing table (see Figure 3), consisting of five rods (3,2 0,1) mm diameter, with a distance between the centres of the two rods

37、of (8,2 0,1) mm, made of a hard metal such as stainless steel. 5.1.1.2 Vertical column, consisting of a gripping block for the brush head such that it does not flex and applies (5 0,05) N to the gripped brush. 5.1.1.3 Load cell, of force range from 0 to 20 N and accurate to 0,05 N, connected to one

38、end of the brushing table. 5.1.1.4 Driving unit, which moves the table back and forth along the longitudinal axis at a rate between 10 mm/s and 50 mm/s (traverse distance: more than the length of a brush head). Key 1 mass to exert force 2 brush head 3 gripping block 4 load cell 5 brushing table 6 ra

39、il 7 support Figure 2 Test machine EN ISO 22254:20055Dimensions in millimetres Key 1 rod 2 bearing 3 support l130 to 40 l4150 to 170 l245 to 50 l555 to 60 l38,2 l655 to 60 Figure 3 Brushing table of test machine 5.2 Test conditions All tests shall be conducted at (23 5) C unless otherwise specified.

40、 5.3 Conditioning of toothbrushes Cut off the brush head at the neck, discard the handle and weigh the brush head to the nearest 0,5 g. Immerse the brush head in water, in accordance with grade 3 of ISO 3696:1987, at (37 2) C for 90 s. After immersion, shake off excess water and fix the brush head i

41、n the gripping device. EN ISO 22254:20056 5.4.1 Positioning of the brush head Attach the gripping device (3) in Figure 2 to the test machine (see Figure 2), such that the tuft hole plane is parallel to the brushing table (5) in Figure 2. Position the brush head in line with the brushing table, avoid

42、ing contact with the rods (1) in Figure 3. Adjust the force on the brush head (2) in Figure 2 to (5 0,05) N, taking into account the mass of a brush head weighed in 5.3. Lower the brush head assembly on to the flat surface of the brushing table, until the load is completely transferred to the table.

43、 NOTE A convenient method of positioning is to make use of a positioning block, e.g. made of a material such as a polyvinylsiloxane impression material (putty type) or epoxy resin, which fits the gripping block. 5.4.2 Measurement of resistance to deflection Within (3 0,25) min after removal of the b

44、rush head from the water, start the sliding movement of the brushing table at a sliding velocity between 10 mm/s and 50 mm/s. At the end of five cycles, record the maximum force in newtons given by the load cell (4) in Figure 2 for each of the two directions. Calculate the mean of the two recorded v

45、alues as the resistance to deflection. Repeat the procedure for the remaining four toothbrushes and calculate the overall mean resistance to deflection. NOTE A cycle is the travel of the brushing table from its original position to the limit of travel and back to the original position. 5.4.3 Test re

46、port Report the resistance to deflection of each of the five toothbrushes tested, the mean resistance to deflection, the standard deviation and name of toothbrush. EN ISO 22254:20057Annex A (informative) Determination of stiffness of the tufted portion of toothbrush The stiffness of the tufted porti

47、on of a toothbrush is determined by the following procedure after the measurement of the resistance to deflection. Remove all tufts from the five tested brush heads and take a photograph or draw a tracing of the tuft hole plane for each of the five heads under three times to ten times magnification.

48、 Measure the tufted area either on the photograph or the tracing to within 0,1 cm2using a planimeter and calculate the tufted area, A, of the brush head. Calculate the stiffness, in newtons per square centimetre (N/cm2) for each toothbrush, using the following formula: Stf= F/A where Stfis the stiff

49、ness; F is the resistance to deflection, in newtons; A is the tufted area, in square centimetres. Report the stiffness of each of the five toothbrushes tested and the mean stiffness. Key 1 tufted area (shaded) 2 tufted hole (black circles) Figure A.1 Tufted portion of toothbrushEN ISO 22254:2005BS EN ISO 22254:2005BSI389 Chiswick High RoadLondonW4 4ALBSI British Standards InstitutionBSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Euro