BS EN ISO 20126-2012 Dentistry Manual toothbrushes General requirements and test methods《牙科学 手动牙刷 一般要求和试验方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 20126:2012Dentistry Manualtoothbrushes Generalrequirements and test methods(ISO 20126:2012)BS EN ISO 20126:2012 BRITISH STANDARDNational forewordThis British Standard i

2、s the UK implementation of EN ISO20126:2012. It supersedes BS EN ISO 20126:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene products.A list of organizations represented on this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 secret

3、ary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 70094 1ICS 97.170Compliance with a British Standard cannot confer

4、 immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20126 March 2012 ICS 97.170 Supersedes

5、EN ISO 20126:2005English Version Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012) Mdecine bucco-dentaire - Brosses dents manuelles - Exigences gnrales et mthodes dessai (ISO 20126:2012) Zahnheilkunde - Handzahnbrsten - Allgemeine Anforderungen und Prfverfahren

6、 (ISO 20126:2012) This European Standard was approved by CEN on 28 January 2012. 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 b

7、ibliographical 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). A version in any other language made by translation under the res

8、ponsibility 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,

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

10、UNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20126:2012: EBS EN ISO 20126:2012EN ISO 20126:2012 (E) 3 Foreword This document (EN ISO 20126:2012) has been prepared

11、 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 endorsement, at the latest

12、 by September 2012, and conflicting national standards shall be withdrawn at the latest by September 2012. 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 identifying any or all

13、 such patent rights. This document supersedes EN ISO 20126:2005. 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, Est

14、onia, Finland, 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. Endorsement notice The text of ISO 20126:2012 has been approv

15、ed by CEN as a EN ISO 20126:2012 without any modification. BS EN ISO 20126:2012ISO 20126:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 14 Requirements . 34.1 Pass-fail criteria . 34.2 Physical inspection . 3

16、4.3 Tuft retention 34.4 Fatigue resistance . 34.5 Chemical challenge . 34.6 Handle impact strength . 35 Test method 35.1 Sampling 35.2 General test conditions . 35.3 Physical inspection . 35.4 Tuft-retention test 45.5 Fatigue resistance test . 55.6 Resistance to chemical challenge 65.7 Handle impact

17、 test 66 Test report . 97 Marking and labelling .108 Packaging 10Bibliography . 11BS EN ISO 20126:2012ISO 20126:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan

18、dards 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 ISO, also t

19、ake 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 the ISO/IEC Directives, Part 2.The main task of technical committees is

20、 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 % of the member bodies casting a vote.Attention is drawn to the possibility

21、 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 20126 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.This second edition cancels and

22、replaces the first edition (ISO 20126:2005), which has been technically revised.The significant difference between this second edition and the first edition is: a requirement (4.6) and a test (5.7) for handle impact resistance have been added.iv ISO 2012 All rights reservedBS EN ISO 20126:2012ISO 20

23、126:2012(E)IntroductionManual toothbrushes are used for the removal of dental plaque and oral debris in order to facilitate oral hygiene. This International Standard is intended to determine the physical properties of manual toothbrushes, including impact resistance.Specific qualitative and quantita

24、tive requirements for freedom from biological hazards are not included in this International Standard. It is recommended that, in assessing possible biological hazards, reference be made to ISO 7405and ISO 10993-1. ISO 2012 All rights reserved vBS EN ISO 20126:2012BS EN ISO 20126:2012Dentistry Manua

25、l toothbrushes General requirements and test methods1 ScopeThis International Standard specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.This International Standard does not apply to manu

26、al interdental brushes and powered oral hygiene devices, as these instruments are covered by separate International Standards.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For und

27、ated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification and test methodsISO 22254, Dentistry Manual toothbrushes Resistance of tufted portion to deflection3 Terms and d

28、efinitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 22254 and the following apply.3.1manual toothbrushhand-powered device, the working end of which carries filaments primarily for cleaning surfaces within the oral cavityNOTE Adapted from ISO 22254:2005, d

29、efinition 3.1.3.2brush headworking end of a manual toothbrush to which the filaments are attachedNOTE Adapted from ISO 22254:2005, definition 3.2.3.3filamentsingle strand within the brush headISO 22254:2005, definition 3.33.4tuftgroup of filaments gathered together and attached to the brush headISO

30、22254:2005, definition 3.43.5tuft-removal forceforce required to remove one tuft from the brush headINTERNATIONAL STANDARD ISO 20126:2012(E) ISO 2012 All rights reserved 1BS EN ISO 20126:2012ISO 20126:2012(E)3.6tuft-hole planeplane between the bases of the tufts (where they meet the tuft-hole surfac

31、e) at the top of the brush head and at the base of the tufts at the bottom of the brush head See Figure 1.NOTE Adapted from ISO 22254:2005, definition 3.6.Key1 tuft-hole surface2 top of brush head3 bottom of brush head4 tuft-hole planeFigure 1 Tuft-hole plane3.7period of oscillation of the pendulumT

32、pperiod, expressed in seconds, of a single complete oscillation (to and fro) of the pendulum, oscillating at angles of oscillation of less than 5 to each side of the verticalISO 13802:1999, definition 3.33.8centre of percussionpoint on pendulum at which a perpendicular impact in the plane of swing d

33、oes not cause reaction forces at the axis of rotation of the pendulumISO 13802:1999, definition 3.43.9pendulum lengthLpdistance, expressed in metres, between the axis of rotation of the pendulum and the centre of percussion (3.8), equal to an equivalent theoretical pendulum mass concentrated at the

34、point which gives the same period of oscillation, Tp(3.7), as the actual pendulumNOTE Adapted from ISO 13802:1999, definition 3.5.2 ISO 2012 All rights reservedBS EN ISO 20126:2012ISO 20126:2012(E)3.10impact lengthdistance between the axis of rotation of the pendulum and the pendulum striking edgeNO

35、TE Adapted from ISO 13802:1999, definition 3.8.4 Requirements4.1 Pass-fail criteriaTest eight samples of each type. If none of the eight samples of each type fail, the sample set passes. If one sample does not meet the minimum requirement, test another eight samples. If no more samples fail, the too

36、thbrush passes. If two or more samples out of the sixteen fail, the toothbrush fails.4.2 Physical inspectionThe toothbrush shall be intact, and free of visible contamination and sharp or rough surfaces when examined according to 5.3.4.3 Tuft retentionThe tuft-removal force shall be not less than 15

37、N when tested according to 5.4.4.4 Fatigue resistanceThe toothbrush shall compete 75 000 cycles without breaking when tested according to 5.5. NOTE A cycle is one application of force followed by removal of the force.4.5 Chemical challengeThe toothbrush shall comply with 4.4 after being subjected to

38、 a chemical challenge according to 5.6.4.6 Handle impact strengthWhen tested in accordance with 5.7, the handle should not fracture. If the handle does fracture, however, the minimum absorbed energy at fracture shall be 0,8 J.5 Test method5.1 SamplingObtain the toothbrushes for testing as manufactur

39、ed and not modified in any way, except as specified in this International Standard. 5.2 General test conditionsConduct the tests using dry toothbrushes at a temperature of (23 5) C and a relative humidity of (50 10) %.5.3 Physical inspectionInspect the toothbrush and related accessories using normal

40、 acuity without magnification. Use tactile inspection to detect sharp or rough surfaces. ISO 2012 All rights reserved 3BS EN ISO 20126:2012ISO 20126:2012(E)5.4 Tuft-retention test5.4.1 Apparatus5.4.1.1 Gripping unit to secure the brush head, having a structure such that compressive force is not indu

41、ced on the tufts. See Figure 2.5.4.1.2 Clamp, for securely holding all the filaments in one tuft, e.g. a tuft-gripping clamp or a Collet chuck used to grip a tuft, and consisting of an outer shell that slips over the filaments and a probe which screws into the shell, pinching the filaments between i

42、t and the shell.5.4.1.3 Apparatus for applying, measuring and indicating the removal force, e.g. digital force gauge or universal testing machine (force range: 5 N to 50 N, accuracy: 0,1 N, range of pulling speed: 20 mm/min to 100 mm/min).5.4.2 ProcedurePlace the toothbrush in the gripping unit (5.4

43、.1.1) and lock it into place so that the clamp (5.4.1.2) pulls the tuft along the long axis of the tuft, without any twisting. Do not compress the tufts during or after placement.Place the clamp on the filament tuft, ensuring that all the filaments from one tuft only are clamped; do not include fila

44、ments from the surrounding tufts. Secure the filaments from the tuft at approximately the mid-point of the tuft length. Record the force required to pull out the tuft using the testing apparatus (5.4.1.3).Test two non-adjacent tufts of each type (if available). 4 ISO 2012 All rights reservedBS EN IS

45、O 20126:2012ISO 20126:2012(E)Key1 brush head2 brush-head gripping device Figure 2 Example of gripping unit for tuft-retention test5.5 Fatigue resistance test5.5.1 Apparatus5.5.1.1 Block for holding the toothbrush body stationary, having a ridge for supporting the toothbrush at (55 1) mm from the cen

46、tre of the brush head and a gripping unit for locking the handle of the toothbrush in place.5.5.1.2 Apparatus for applying a (4,0 0,1) N force to the brush head and then fully relieving the force.5.5.1.3 Apparatus for counting the number of cycles completed.5.5.1.4 Apparatus for stopping the applica

47、tion of force when either of the following conditions has occurred:a) completion of the required number of cycles;b) handle breakage.5.5.2 ProcedureCut the filaments, and any other attachments, flush to the brush head. Protect the brush head by covering the head with adhesive tape (thickness: less t

48、han 0,2 mm). Place the toothbrush against the block with the tuft-hole ISO 2012 All rights reserved 5BS EN ISO 20126:2012ISO 20126:2012(E)plane perpendicularly facing the applied force. Lock the toothbrush in place, ensuring that the ridge is at (55 1) mm from the centre of the brush head.NOTE If th

49、e test specimen cannot be locked in place due to its configuration, embed the specimen in epoxy resin or dental stone, ensuring that the surface level of epoxy resin or dental stone is at (55 1) mm from the centre of the brush head.Apply a (4,0 0,1) N force to the centre of the brush head perpendicularly to the tuft-hole plane with minimal impact and then fully relieve the force. Repeat a maximum of 75 000 cycles at (50 10) cycles/min or until the handle breaks. Record the breakage if it is induced