EN ISO 20127-2005 en Dentistry - Powered toothbrushes - General requirements and test methods《牙科学 电动牙刷 一般要求和试验方法 ISO 20127-2005》.pdf

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1、BRITISH STANDARDBS EN ISO 20127:2005Dentistry Powered toothbrushes General requirements and test methodsThe European Standard EN ISO 20127:2005 has the status of a British StandardICS 97.170g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g

2、51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 20127:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 2 November 2005 BSI 2 November 2005ISBN 0 580 46591 8National forewordThis British S

3、tandard is the official English language version of EN ISO 20127:2005. It is identical with ISO 20127:2005.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/7, Oral hygiene products, which has the responsibility to: A list of organ

4、izations 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 the BSI Catalogue under the section entitled “International Standards Corres

5、pondence 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 for its correct application. Compliance with a British Standard does not of

6、 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 interests informed; monitor related international and European developments and

7、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 6, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicat

8、es when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 20127March 2005ICS 97.170English versionDentistry - Powered toothbrushes - General requirements andtest methods (ISO 20127:2005)Art dentaire - Brosses d

9、ents lectriques - Exigencesgnrales et mthodes dessai (ISO 20127:2005)Zahnheilkunde - Physikalische Eigenschaften vonelektrischen Zahnbrsten (ISO 20127:2005)This European Standard was approved by CEN on 14 February 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which s

10、tipulate 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 application to the Central Secretariat or to any CEN member.This European Standard e

11、xists 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 has the same status as the officialversions.CEN members are the national standards bod

12、ies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR S

13、TANDARDIZATIONCOMIT 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 CEN national Members.Ref. No. EN ISO 20127:2005: EForeword This document (EN ISO 201

14、27:2005) 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 given the status of a national standard, either by publication of an identical text or by

15、 endorsement, at the latest by September 2005, and conflicting national standards shall be withdrawn at the latest by September 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Aust

16、ria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of I

17、SO 20127:2005 has been approved by CEN as EN ISO 20127:2005 without any modifications. EN ISO 20127:2005Reference numberISO 20127:2005(E)INTERNATIONAL STANDARD ISO20127First edition2005-03-15Dentistry Powered toothbrushes General requirements and test methods Art dentaire Brosses dents lectriques Ex

18、igences gnrales et mthodes dessai EN ISO 20127:2005ii 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 through ISO technical committee

19、s. 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 collaborates closely with the Inter

20、national 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 Standards. Draft International St

21、andards 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 of this document may be the sub

22、ject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 20127 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral hygiene products. EN ISO 20127:2005iv Introduction Powered toothbrushes are used for the removal of den

23、tal plaque and oral debris in order to facilitate oral hygiene. EN ISO 20127:20051Dentistry Powered toothbrushes General requirements and test methods 1 Scope This International Standard specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote t

24、he safety of these products for their intended use. Specifically excluded are other types of powered oral hygiene devices (such as powered interdental brushes) and manual toothbrushes. 2 Normative references The following referenced documents are indispensable for the application of this document. F

25、or dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 3696:1987, Water for analytical laboratory use Specification and test methods IEC 60335-1:2004, Household

26、and similar electrical appliances Safety Part 1: General requirements IEC 60335-2-52, Household and similar electrical appliances Safety Part 2-52: Particular requirements for oral hygiene appliances 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 19

27、42 and the following apply. 3.1 powered toothbrush hand-held electrically-powered appliance, the brush head of which carries filaments, used primarily for cleaning surfaces within the oral cavity 3.2 brush head fixed or removable working end of an electrically-powered toothbrush to which the filamen

28、ts 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 EN ISO 20127:20052 3.5 tuft removal force force required to remove one tuft from the brush head 4 Requirements 4.1 Pass-fail criteria Eight electrically-power

29、ed toothbrushes shall be tested. If none of the eight sampled powered toothbrushes fail, the powered toothbrush passes. If one toothbrush does not meet the minimum requirement, another eight powered toothbrushes shall be tested. If no more toothbrushes fail, the powered toothbrush passes. If a total

30、 of two or more powered toothbrushes of the sixteen fail, the powered toothbrush fails. 4.2 Physical inspection The powered toothbrush, its components and all accessories shall be intact and free of visible contamination and sharp or rough surfaces when examined according to 5.3. 4.3 Electrical safe

31、ty All the powered toothbrushes and related accessories shall conform to the requirements described in IEC 60335-1 and IEC 60335-2-52. 4.4 Tuft retention The tuft removal force shall not be less than 15 N when tested according to 5.4. 4.5 Mechanical strength All powered toothbrushes and related acce

32、ssories shall conform to the requirements described in IEC 60335-1:2004, Clause 21 and IEC 60335-2-52. 4.6 Resistance to chemical challenge After being subjected to a chemical challenge test according to 5.5, the brush head shall conform to the requirements of the spring operated impact test as desc

33、ribed in IEC 60335-1:2004, Clause 21, and the brush head shall be operational and free of sharp or rough surfaces when examined. 5 Test methods 5.1 Sampling The powered toothbrushes obtained for testing shall be as manufactured and not modified in any way except as specified for this International S

34、tandard. Eight powered toothbrushes of each type shall be tested. 5.2 General test conditions All tests shall be conducted using dry brushes at (23 5) C and relative humidity (50 10) %. 5.3 Physical inspection Inspection of the powered toothbrush and related accessories shall be performed using norm

35、al visual acuity without magnification. Tactile inspection shall also be performed to detect sharp or rough surfaces. EN ISO 20127:200535.4 Tuft retention 5.4.1 Apparatus 5.4.1.1 Gripping unit, to secure the brush head, having a structure such that compressive force is not induced on the brush head

36、(Figure A.1). 5.4.1.2 Clamp for securely holding all of the filaments in one tuft, for example a tuft gripping clamp (see Figure A.2). A collet chuck can also be used. 5.4.1.3 Apparatus for applying, measuring and indicating the removal force, a digital force gauge or a universal testing machine (fo

37、rce range from 5 N to 50 N, accurate to 0,1 N and a range of pulling speed from 20 mm/min to 100 mm/min). 5.4.2 Procedure Place the brush in the gripping unit (5.4.1.1) and lock into place so that the clamp (5.4.1.2) pulls the tuft along the long axis of the tuft without any twisting. The brush head

38、 shall not be compressed during and after the placement. Place the clamp on the filament tuft. Be sure to clamp all of the filaments from one tuft only; do not include filaments from the surrounding tufts. The filaments from one tuft should be secured at approximately the midpoint of the tuft length

39、. Record the force required to pull out the tuft using the testing apparatus (5.4.1.3). Test two tufts of each tuft type (if available). The tufts should be non-adjacent. 5.5 Resistance to chemical challenge 5.5.1 Apparatus and chemicals 5.5.1.1 Apparatus for mixing the chemical challenge, for examp

40、le stirring bar or mixer. 5.5.1.2 Container which can be sealed and is chemically inert, for example a polypropylene bottle. 5.5.1.3 Chemicals, of minimum purity and of the amounts listed in the Table 1. Table 1 Quantity and purity of products used Chemicals Minimum purity Amount g Ethanol 98,5 % 10

41、0 L-carvone 98,0 1,5 L-menthol 98,0 % 1,5 Sodium lauryl sulfate 95,0 % 15,0 Glycerine 98,0 200 Water ISO 3696:1987, Grade 3 682 5.5.2 Procedure Add 1,5 g L-carvone, 1,5 g L-menthol, 15 g sodium lauryl sulphate to 100 g ethanol in the container and stir well. Add 250 g water (ISO 3696:1987, Grade 3)

42、and stir well to obtain a clear solution. Add 200 g glycerine and 432 g water (ISO 3696:1987, Grade 3) and stir to obtain a clear solution. Place the removable brush head in the chemical-challenge solution. Ensure that the portion of the head containing filaments and at least 80 % of the total lengt

43、h of the removable head is immersed. If the head is not EN ISO 20127:20054 removable, immerse the portion of the head containing filaments and an additional 80 % of the portion of the head exposed to a chemical challenge during normal toothbrushing. After immersion seal container. After 24 h without

44、 agitation, remove the toothbrush, rinse with water (ISO 3696:1987, Grade 3) and shake off excess water. Perform the spring-operated impact test as described in IEC 60335-1:2004, Clause 21. 6 Test report The test report shall contain the following information: a) identification of the powered toothb

45、rush; b) results and the units of measure used; c) any unusual features noted during the test; d) reference to this International Standard (ISO 20127:2004); e) statement of conformance with this International Standard. 7 Marking and labelling 7.1 Powered toothbrush components The powered toothbrush,

46、 all components and related accessories shall be marked in accordance with IEC 60335-1 and IEC 60335-2-52. The powered toothbrush shall also be marked with a manufacturers tracking code. 7.2 Instructions for use The product shall be supplied with instructions for use, maintenance and disposal and in

47、formation on electrical safety (including warnings). 7.3 Marking and labelling The packaging of powered toothbrushes shall be marked or labelled with the following information: a) name and address of manufacturer and/or responsible distributor; b) trade name; c) list of contents; d) tracking code. 8

48、 Packaging The packaging shall be such that it will neither contaminate nor permit contamination of the powered toothbrush when examined in accordance with 5.3. EN ISO 20127:20055Annex A (informative) Gripping devices Key 1 brush head 2 brush-head gripping device Figure A.1 Brush-head gripping unit

49、EN ISO 20127:20056 Key 1 tuft 2 tuft gripping clamp Figure A.2 Tuft gripping clamp EN ISO 20127:2005blankBS EN ISO 20127:2005BSI389 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 Europe and at the international level. It is incorporated by Royal Charter.RevisionsBritish Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest a