EN ISO 21672-1-2012 en Dentistry - Periodontal probes - Part 1 General requirements《牙科学 牙周探器 第1部分 总要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 21672-1:2012Dentistry Periodontal probesPart 1: General requirements (ISO 21672-1:2012)BS EN ISO 21672-1:2012 BRITISH STANDARDNational forewordThis British Standard is

2、the UK implementation of EN ISO 21672-1:2012.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.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 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 69611 4 ICS 11.060.25 Compliance with a British Standard cannot confer immunity from legal obligations.

4、This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2012.Amendments issued since publicationDate T e x t a f f e c t e d EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21672-1 April 2012 ICS 11.060.25 English Version Dentistry

5、- Periodontal probes - Part 1: General requirements (ISO 21672-1:2012) Mdecine bucco-dentaire - Sondes parodontales - Partie 1: Exigences gnrales (ISO 21672-1:2012) Zahnheilkunde - Parodontalsonden - Teil 1: Allgemeine Anforderungen (ISO 21672-1:2012) This European Standard was approved by CEN on 31

6、 March 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 bibliographical references concerning such national standards may be

7、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 member into its own language and notified to th

8、e 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo

9、urg, 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 NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN Al

10、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21672-1:2012: EBS EN ISO 21672-1:2012EN ISO 21672-1:2012 (E) 3 Foreword This document (EN ISO 21672-1:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaborat

11、ion 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 by October 2012, and conflicting national standards shall b

12、e withdrawn at the latest by October 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 such patent rights. According to the CEN/CENELEC Internal Regul

13、ations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

14、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21672-1:2012 has been approved by CEN as a EN ISO 21672-1:2012 without any modification. BS EN ISO 21672-1:2012ISO 21672-1:2012(E)Fore

15、wordISO (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 committees. Each member body interested in a subject for which a techni

16、cal 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 International Electrotechnical Commission (IEC) on all matters of e

17、lectrotechnical 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 Standards adopted by the technical committees are circulated to th

18、e 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 subject of patent rights. ISO shall not be held responsible for iden

19、tifying any or all such patent rights.ISO 21672-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.ISO 21672 consists of the following parts, under the general title Dentistry Periodontal probes: Part 1: General requirements Part 2: Designation ISO 201

20、2 All rights reserved iiiBS EN ISO 21672-1:2012BS EN ISO 21672-1:2012Dentistry Periodontal probes Part 1: General requirements1 ScopeThis part of ISO 21672 specifies general requirements and test methods for periodontal probes.It is applicable to periodontal probes made of austenitic and martensitic

21、 stainless steel.It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For date

22、d references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6892-1, Metallic materials Tensile testing

23、Part 1: Method of test at room temperatureISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steelISO 13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure3 Terms, definitions and symbols3.1 Terms and definition

24、sFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1.1periodontal probedental hand instrument designed to measure subgingival pocket depth, used in dentistry for diagnostic purposes and assessment of the condition of periodontal pockets3.1.2furc

25、ation probeperiodontal probe designed to probe the furcations of premolars and molars3.2 Symbolsb1blade thicknessb2blade widthd1diameter of spherical or round endINTERNATIONAL STANDARD ISO 21672-1:2012(E) ISO 2012 All rights reserved 1BS EN ISO 21672-1:2012ISO 21672-1:2012(E)d2diameter of shankh1bla

26、de heighth2shank heightR1radius of shankR2radius of working end blade angle offset angle4 ClassificationFor the purposes of this part of ISO 21672, periodontal probes are classified according to their intended function and their shapes into the following five types: Type 1, in accordance with Figure

27、 1; Type 2, in accordance with Figure 2; Type 3, in accordance with Figure 3; Type 4, in accordance with Figure 4; Type 5, furcation probe, in accordance with Figure 5.2 ISO 2012 All rights reservedBS EN ISO 21672-1:2012ISO 21672-1:2012(E)aEnlarged view of the working end.Figure 1 Dimensions of Type

28、 1 probes ISO 2012 All rights reserved 3BS EN ISO 21672-1:2012ISO 21672-1:2012(E)aEnlarged view of the two possible versions for the working end: spherical (d1) or oval (b1, b2).Figure 2 Dimensions of Type 2 probes4 ISO 2012 All rights reservedBS EN ISO 21672-1:2012ISO 21672-1:2012(E)aEnlarged view

29、of the two possible versions for the working end: spherical (d1) or oval (b1, b2).Figure 3 Dimensions of Type 3 probes ISO 2012 All rights reserved 5BS EN ISO 21672-1:2012ISO 21672-1:2012(E)Figure 4 Dimensions of Type 4 probes6 ISO 2012 All rights reservedBS EN ISO 21672-1:2012ISO 21672-1:2012(E)Fig

30、ure 5 Dimensions of Type 5 probes5 Requirements5.1 Design and dimensionsPeriodontal probes shall have one of the designs shown in Figure 1 to Figure 5 and the dimensions given in Table 1.Table 1 Dimensions for periodontal probesDimensions in millimetresAngles in degreesType of probeQuantity and tole

31、ranceb1a0,1b2a0,1d1 0,05d2 0,05h1 2h2 2R1 1R2 1 5 51 0,6 0,4 6,6 7,5 2 60 2 0,5 1,5 0,5 12,0 2 60 3 0,5 1,5 0,5 8,4 4,5 2 60 4 0,5 9,5 7,0 2 60 5 0,4 6,2 6,3 4,7 6,5 35 20aThe working end of Type 2 and Type 3 has a cross-section that is either circular, or rectangular and flat with rounded corners.

32、ISO 2012 All rights reserved 7BS EN ISO 21672-1:2012ISO 21672-1:2012(E)5.2 Working end5.2.1 Graduated scaleThe working end of the periodontal probe shall have a graduated scale, in order to allow the measurement of periodontal pockets. The tolerances of each graduation, measured from the distal end

33、of the tip, shall be 0,2 mm. The graduated scale may be colour-coded or non-colour-coded.The periodontal probes specified in Table 2 shall have a graduated scale in accordance with Table 2. Graduated scales for other periodontal probes are at the discretion of the manufacturer.Table 2 Graduated scal

34、es for periodontal probesDimensions in millimetresType Pattern name Figure Graduated scale1 WHO, PCP 11,5 Figure 1 3,5 5,5 8,5 11,52 Merritt, PCP 10 Figure 2 1 2 3 5 7 8 9 103 Goldman-Fox Figure 3 1 2 3 5 7 8 9 104PCP 11 or PCP 12 or PCP N 22 or QOWFigure 43 6 8 11 or 3 6 9 12 or 2 4 6 8 10 125 Nabe

35、rs Figure 5 3 6 9 125.2.2 Shape of the working endThe shape of the working end of periodontal probes shall have one of the following profiles (see Figure 6):a) spherical end (circular cross-section);b) domed end (rectangular cross-section);c) flat end with rounded corners (rectangular cross-section)

36、.a) Spherical end b) Domed end c) Flat end with rounded cornersFigure 6 Profiles of the working end8 ISO 2012 All rights reservedBS EN ISO 21672-1:2012ISO 21672-1:2012(E)5.2.3 Material of the working endThe working ends of periodontal probes shall be made of stainless steel complying with ISO 7153-1

37、. Other stainless steel materials may also be used provided the periodontal probes made of these materials meet the requirements of Clause 5.5.2.4 Hardness and tensile strength of the working end5.2.4.1 Martensitic stainless steel Vickers hardnessThe Vickers hardness of the working end of the period

38、ontal probe made of martensitic stainless steel shall be within the following range: 500 HV 1 to 650 HV 1.The Vickers hardness shall be measured in accordance with ISO 6507-1 or, alternatively, ISO 15087-1:1999, Annex B.5.2.4.2 Austenitic stainless steel Tensile strengthThe tensile strength of the w

39、orking end of the periodontal probe made of austenitic stainless steel shall be within the following range: 1 600 MPa to 1 800 MPa based on wire diameter.The wire diameter is at the discretion of the manufacturer.The tensile strength shall be measured in accordance with ISO 6892-1.5.2.5 RigidityThe

40、working end of the periodontal probe shall not fracture when a rigidity test is performed in accordance with 6.4.The tip of the working end shall not exhibit permanent deformation of more than 0,05 mm measured along the axis of the handle.5.3 HandleThe material of the handle of the periodontal probe

41、, selected at the discretion of the manufacturer, shall meet the requirements of 6.2.5.4 Surfaces5.4.1 All surfacesAll surfaces shall be visibly free from pores, crevices, grinding marks, residual scales, acid, grease and residual grinding and polishing materials.Surfaces shall be tested in accordan

42、ce with 6.1.5.4.2 Satin finishIf a satin finish is used on any part of the instrument, it shall be both uniform and smooth and shall reduce glare.Satin finishes shall be tested in accordance with 6.1.5.5 Maximum overall lengthThe maximum overall length of the periodontal probe shall be less than 178

43、 mm.NOTE This size limitation is intended to make the instrument compliant with current designs of autoclave trays and cassettes. ISO 2012 All rights reserved 9BS EN ISO 21672-1:2012ISO 21672-1:2012(E)5.6 Resistance to reprocessing proceduresWhen tested in accordance with 6.2.2, there shall be no vi

44、sible signs of deterioration. When tested in accordance with 6.3, there shall be no deterioration in tensile load or torque and no change in hardness value or rigidity.5.7 Resistance to corrosion and thermal exposureWhen tested in accordance with 6.2.3, there shall be no visible signs of corrosion.

45、When tested in accordance with 6.3, there shall be no deterioration in tensile load or torque and no change in hardness value or rigidity.5.8 Union of working end and handleThe tested working end of the periodontal probe shall not separate from the handle or become loose under tensile load when test

46、ed in accordance with 6.3.1, and under torque when tested in accordance with 6.3.2.6 Test methods6.1 Visual inspectionConduct visual inspection at normal acuity at no more than 10 magnification.6.2 Resistance tests6.2.1 Test sequence and cyclesPerform one of the two tests given in 6.2.2 and 6.2.3, i

47、n one continuous sequence of operation, for five cycles.After completing the test, rub the instrument vigorously with a cloth to remove blemishes.6.2.2 Autoclave testCarry out the autoclave test as specified in ISO 13402.6.2.3 Boiling water test and thermal exposure testCarry out the boiling water t

48、est and the thermal exposure test as specified in ISO 13402.NOTE The combination of the boiling water test and thermal exposure test is used to evaluate the leakage resistance of hollow handles and the tolerance to dry-heat sterilization methods.6.3 Test of union of working end and handle6.3.1 Under

49、 tensile forceSubject the union between the working end and handle to a tensile force of 50 N, applied in the direction parallel to the centre line of the handle, for a duration of at least 5 s.6.3.2 Under torqueSubject the union between the working end and the handle to a torque of 5 Ncm for a duration of at least 5 s.6.4 Rigidity testSubject the working end to a load of