DIN EN ISO 21672-1-2012 Dentistry - Periodontal probes - Part 1 General requirements (ISO 21672-1 2012) German version EN ISO 21672-1 2012《牙科学 牙周探器 第1部分 总要求(ISO 21672-1-2012) 德文版本E.pdf

1、July 2012 Translation by DIN-Sprachendienst.English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1

2、1.060.25!$,q“1900978www.din.deDDIN EN ISO 21672-1Dentistry Periodontal probes Part 1: General requirements (ISO 21672-1:2012)English translation of DIN EN ISO 21672-1:2012-07Zahnheilkunde Parodontalsonden Teil 1: Allgemeine Anforderungen (ISO 21672-1:2012)Englische bersetzung von DIN EN ISO 21672-1:

3、2012-07Mdecine bucco-dentaire Sondes parodontales Partie 1: Exigences gnrales (ISO 21672-1:2012)Traduction anglaise de DIN EN ISO 21672-1:2012-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 16 pages06.12 DIN EN ISO 21672-1:2012-07 2

4、A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its p

5、reparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-23 AA Dentalmedizinische Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 6507-1 DIN EN ISO 6507

6、-1 ISO 6892-1 DIN EN ISO 6892-1 ISO 7153-1 DIN EN ISO 7153-1 ISO 13402 DIN EN ISO 13402 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method DIN EN ISO 6892-1, Metallic materials Tensile te

7、sting Part 1: Method of test at room temperature DIN EN ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel DIN EN ISO 13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure EUROPEAN STANDARD NORME EUROPENNE

8、 EUROPISCHE NORM EN ISO 21672-1 April 2012 ICS 11.060.25 English Version Dentistry - 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: Allgemein

9、e Anforderungen (ISO 21672-1:2012) This European Standard was approved by CEN on 31 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-d

10、ate lists and bibliographical 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 translatio

11、n under the responsibility 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, Fr

12、ance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploi

13、tation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21672-1:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGDIN EN ISO 21672-1:2012-07 EN ISO 21672-1:2012 (E) 2Foreword This document (EN ISO 21672-

14、1:2012) 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 e

15、ndorsement, at the latest by October 2012, and conflicting national standards shall be 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 i

16、dentifying any or all such patent rights. 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, Estonia, Finland, France,

17、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 21672-1:2012 has been approved by CEN as a EN ISO

18、 21672-1:2012 without any modification. 1 ScopeThis part of ISO 21672 species general reTuirements and test methods for periodontal probes.It is applicable to periodontal probes made of austenitic and martensitic stainless steel.It is not applicable to periodontal probes with working ends made compl

19、etel of plastics nor to +A8ER probes and periodontal probes with a dened probing force.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references onl the edition cited applies. For undated references the latest edition of the

20、 referenced document (including an amendments) applies.ISO 1942 Dentistry VocabularyISO 607-1 Metallic materials Vickers hardness test Part 1: Test methodISO 692-1 Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 71-1 Surgical instruments Metallic materials Part 1: St

21、ainless steelISO 1402 Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure 7HUPVGHQLWLRQVDQGVPEROV 7HUPVDQGGHQLWLRQVFor the purposes of this document the terms and denitions given in ISO 1942 and the following appl.3.1.1periodontal prob

22、edental hand instrument designed to measure subgingival pocket depth used in dentistr for diagnostic purposes and assessment of the condition of periodontal pockets3.1.2furcation probeperiodontal probe designed to probe the furcations of premolars and molars3.2 Symbolsb1blade thicknessb2blade widthd

23、1diameter of spherical or round endDIN EN ISO 21672-1:2012-07EN ISO 21672-1:2012 (E) 3d2diameter of shankh1blade heighth2shank heightR1radius of shankR2radius of working endD blade angleE offset angle &ODVVLFDWLRQFor the purposes of this part of ISO 21672 periodontal probes are classied according to

24、 their intended function and their shapes into the following ve tpes: Tpe 1 in accordance with Figure 1 Tpe 2 in accordance with Figure 2 Tpe in accordance with Figure Tpe 4 in accordance with Figure 4 Tpe furcation probe in accordance with Figure .DIN EN ISO 21672-1:2012-07 EN ISO 21672-1:2012 (E)

25、4aEnlarged view of the working end.Figure 1 Dimensions of Type 1 probesDIN EN ISO 21672-1:2012-07EN ISO 21672-1:2012 (E) 5aEnlarged view of the two possible versions for the working end: spherical (d1) or oval (b1 b2).Figure 2 Dimensions of Type 2 probesDIN EN ISO 21672-1:2012-07 EN ISO 21672-1:2012

26、 (E) 6aEnlarged view of the two possible versions for the working end: spherical (d1) or oval (b1 b2).Figure 3 Dimensions of Type 3 probesDIN EN ISO 21672-1:2012-07EN ISO 21672-1:2012 (E) 7Figure 4 Dimensions of Type 4 probesDIN EN ISO 21672-1:2012-07 EN ISO 21672-1:2012 (E) 8Figure 5 Dimensions of

27、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 toleranceb1ar01b2ar01d1

28、r005d2 r005h1 r2h2 r2R1 r1R2 r1D r5E r5160466752 602051505120 2 60 30515054452 6040595702 605 46263476535 20aThe working end of Tpe 2 and Tpe 3 has a cross-section that is either circular or rectangular and at with rounded corners.DIN EN ISO 21672-1:2012-07EN ISO 21672-1:2012 (E) 95.2 Working end5.2

29、.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 of the tip shall be r02 mm. The graduated scale ma be colour-coded or non-colour-coded.The

30、periodontal probes specied in Table 2 shall have a graduated scale in accordance with Table 2. *raduated scales for other periodontal probes are at the discretion of the manufacturer.Table 2 Graduated scales for periodontal probesDimensions in millimetresType Pattern name Figure Graduated scale1W+O

31、PCP 115Fgure 1 35 55 85 1152 0erritt PCP 10 Figure 2 1 2 3 5 7 8 9 103 *oldman-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 Nabers Figure 5 3 6 9 125.2.2 Shape of the working endThe shape of the working end of periodontal probes shal

32、l have one of the following proles (see Figure 6):a) spherical end (circular cross-section)b) domed end (rectangular cross-section)c) at end with rounded corners (rectangular cross-section).a) Spherical end b) Domed end c) Flat end with rounded corners)LJXUH3UROHVRIWKHZRUNLQJHQGDIN EN ISO 21672-1:20

33、12-07 EN ISO 21672-1:2012 (E) 105.2.3 Material of the working endThe working ends of periodontal probes shall be made of stainless steel compling with ISO 7153-1. Other stainless steel materials ma also be used provided the periodontal probes made of these materials meet the reTuirements of Clause 5

34、.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 periodontal probe made of martensitic stainless steel shall be within the following range: 500 +V 1 to 650 +V 1.The Vickers hardness shall be meas

35、ured in accordance with ISO 6507-1 or alternativel ISO 15087-1:1999 Annex %.5.2.4.2 Austenitic stainless steel Tensile strengthThe tensile strength of the working 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

36、 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 working end of the periodontal probe shall not fracture when a rigidit test is performed in accordance with 6.4.The tip of the working end shall

37、 not exhibit permanent deformation of more than 005 mm measured along the axis of the handle.5.3 HandleThe material of the handle of the periodontal probe selected at the discretion of the manufacturer shall meet the reTuirements of 6.2.5.4 Surfaces5.4.1 All surfacesAll surfaces shall be visibl free

38、 from pores crevices grinding marks residual scales acid grease and residual grinding and polishing materials.Surfaces shall be tested in accordance with 6.1. 6DWLQQLVKIf a satin nish is used on an part of the instrument it shall be both uniform and smooth and shall reduce glare.Satin nishes shall b

39、e tested in accordance with 6.1.5.5 Maximum overall lengthThe maximum overall length of the periodontal probe shall be less than 178 mm.NOTE This sie limitation is intended to make the instrument compliant with current designs of autoclave tras and cassettes.11DIN EN ISO 21672-1:2012-07EN ISO 21672-

40、1:2012 (E) 5.6 Resistance to reprocessing proceduresWhen tested in accordance with 6.2.2 there shall be no visible signs of deterioration. When tested in accordance with 6.3 there shall be no deterioration in tensile load or torTue and no change in hardness value or rigidit.5.7 Resistance to corrosi

41、on and thermal exposureWhen tested in accordance with 6.2.3 there shall be no visible signs of corrosion. When tested in accordance with 6.3 there shall be no deterioration in tensile load or torTue and no change in hardness value or rigidit.5.8 Union of working end and handleThe tested working end

42、of the periodontal probe shall not separate from the handle or become loose under tensile load when tested in accordance with 6.3.1 and under torTue when tested in accordance with 6.3.2.6 Test methods6.1 Visual inspectionConduct visual inspection at normal acuit at no more than u10 magnication.6.2 R

43、esistance tests6.2.1 Test sequence and cyclesPerform one of the two tests given in 6.2.2 and 6.2.3 in one continuous seTuence of operation for ve ccles.After completing the test rub the instrument vigorousl with a cloth to remove blemishes.6.2.2 Autoclave testCarr out the autoclave test as specied i

44、n ISO 13402.6.2.3 Boiling water test and thermal exposure testCarr out the boiling water test and the thermal exposure test as specied 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

45、to dr-heat steriliation methods.6.3 Test of union of working end and handle6.3.1 Under tensile forceSubMect 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 torqueSubM

46、ect the union between the working end and the handle to a torTue of 5 Ncm for a duration of at least 5 s.6.4 Rigidity testSubMect the working end to a load of 50 g applied in the direction parallel to the centre line of the handle with the test apparatus illustrated in Figure 7 for a duration of 60 s.DIN EN ISO 21672-1:2012-07 EN ISO 21672-1:2012 (E) 12Key1 clamping knob2 mass of 50 g3 guide bushing with an inner diameter of 37 mm4 supporting arm5 periodontal probe under test6 at base7 round shaftFigure 7 Test apparatus