BS EN ISO 21672-2-2012 Dentistry Periodontal probes Designation《牙科 牙周探针 命名》.pdf

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1、BSI Standards PublicationBS EN ISO 21672-2:2012Dentistry - Periodontal probesPart 25: DesignationBS EN ISO 21672-2:2012Incorporating corrigendum October 2013Part 2: DesignationBS EN ISO 21672-2:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 21672-2:201

2、2.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to inclu

3、de all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 84614 4ICS 11.060.25Compliance with a British Standard cannot confer immunity from legal obligations.This Br

4、itish Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments/corrigenda issued since publicationDate Text affected31 October 2013 Part number on front cover correctedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21672-2 Sept

5、ember 2012 ICS 11.060.25 English Version Dentistry - Periodontal probes - Part 2: Designation (ISO 21672-2:2012) Mdecine bucco-dentaire - Sondes parodontales - Partie 2: Dsignation (ISO 21672-2:2012) Zahnheilkunde - Parodontalsonden - Teil 2: Bezeichnung (ISO 21672-2:2012) This European Standard was

6、 approved by CEN on 14 September 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

7、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 responsibility of a CEN member into its own l

8、anguage 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, Former Yugoslav Republic of Macedonia, France, Germany, Gre

9、ece, 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 NORMUNG

10、 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 21672-2:2012: EBS EN ISO 21672-2:2012EN ISO 21672-2:2012 (E) 3 Foreword This document (EN ISO 21672-2:2012) has been pre

11、pared 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 l

12、atest by March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. 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 su

13、ch patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Mace

14、donia, 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 21672-2:2012 has been approved by

15、CEN as a EN ISO 21672-2:2012 without any modification. BS EN ISO 21672-2:2012EN ISO 21672-2:2012 (E) 3 Foreword This document (EN ISO 21672-2:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which

16、 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 March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. Attention is drawn to the possibilit

17、y 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 Regulations, the national standards organisations of the following countries are bou

18、nd to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga

19、l, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21672-2:2012 has been approved by CEN as a EN ISO 21672-2:2012 without any modification. BS EN ISO 21672-2:2012EN ISO 21672-2:2012 (E) 3 Foreword his document (EN ISO 21672-2

20、: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 en

21、dorsement, at the latest by March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. 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 identi

22、fying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugosl

23、av Republic of Macedonia, France, Germany, Greece, Hungary, Ic l nd, 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 21672-2:2012 ha

24、s been approved by CEN as a EN ISO 21672-2:2012 without any modification. BS EN ISO 21672-2:2012Dentistry Periodontal probes Part 2: Designation1 ScopeThis part of ISO 21672 specifies the designation of periodontal probes.2 Normative referencesThe following referenced documents are indispensable for

25、 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, Dentistry VocabularyISO 21672-1:2012, Dentistry Periodontal probes Part 1: General requirements3

26、 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 21672-1 and the following apply.3.1pattern namespecific brand name for the periodontal probe, defined by the manufacturer4 Designation4.1 GeneralPeriodontal probes shall be designated by thei

27、r pattern name and their functional designation, specified by four digits in accordance with 4.2 to 4.5.designation = pattern name functional designationfunctional designation = type/graduated scale/profile/colour coding = digit 1/digit 2/digit 3/digit 4Annex A provides examples of different designa

28、tions for periodontal probes.4.2 First digit: TypeThe first digit shall refer to the type of periodontal probe, as specified in Table 1. The types of periodontal probes shall be in accordance with the classification in ISO 21672-1:2012, Clause 4.INTERNATIONAL STANDARD ISO 21672-2:2012(E) ISO 2012 Al

29、l rights reserved 1BS EN ISO 21672-2:2012Dentistry Periodontal probes Part 2: Designation1 ScopeThis part of ISO 21672 specifies the designation of periodontal probes.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references

30、, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 21672-1:2012, Dentistry Periodontal probes Part 1: General requirements3 Terms and definitionsFor the purposes of this document

31、, the terms and definitions given in ISO 1942 and ISO 21672-1 and the following apply.3.1pattern namespecific brand name for the periodontal probe, defined by the manufacturer4 Designation4.1 GeneralPeriodontal probes shall be designated by their pattern name and their functional designation, specif

32、ied by four digits in accordance with 4.2 to 4.5.designation = pattern name functional designationfunctional designation = type/graduated scale/profile/colour coding = digit 1/digit 2/digit 3/digit 4Annex A provides examples of different designations for periodontal probes.4.2 First digit: TypeThe f

33、irst digit shall refer to the type of periodontal probe, as specified in Table 1. The types of periodontal probes shall be in accordance with the classification in ISO 21672-1:2012, Clause 4.INTERNATIONAL STANDARD ISO 21672-2:2012(E) ISO 2012 All rights reserved 1BS EN ISO 21672-2:2012ISO 21672-2:20

34、12(E)Table 1 First digit: TypeType DigitNot specified 0Type 1 1Type 2 2Type 3 3Type 4 4Type 5 54.3 Second digit: Graduated scaleThe second digit refers to the graduated scale of the working end of the periodontal probe as specified in Table 2. Further information about the graduated scale is given i

35、n ISO 21672-1:2012, 5.2.1.Table 2 Second digit: Graduated scaleGraduated scale of working endmmDigitNot specified 03,5 5,5 8,5 11,5 11 2 3 5 7 8 9 10 23 6 8 11 33 6 9 12 42 4 6 8 10 12 54.4 Third digit: ProfileThe third digit refers to the profile of the working end of the periodontal probe as speci

36、fied in Table 3. Further information about the profile of the working end is given in ISO 21672-1:2012, 5.2.2 and Figure 6.Table 3 Third digit: ProfileProfile of working end DigitNot specified 0Spherical end 1Domed end 2Rectangular flat end with rounded corners 34.5 Fourth digit: Colour codingThe fo

37、urth digit refers to the colour coding of the working end of the periodontal probe as specified in Table 4.Table 4 Fourth digit: Colour codingColour coding of working end DigitNon-colour coded 0Colour coded 12 ISO 2012 All rights reservedBS EN ISO 21672-2:2012ISO 21672-2:2012(E)5 Marking, labelling

38、and catalogue entries5.1 Marking of periodontal probesPeriodontal probes should be indelibly marked with the designation as specified in 4.1. As a minimum requirement, periodontal probes shall be indelibly marked with their pattern name.5.2 Labelling on the primary packaging of periodontal probesThe

39、 primary packaging of the periodontal probes should be labelled with the designation as specified in 4.1. As a minimum requirement, the primary packaging shall be labelled with their pattern name.5.3 Catalogue entriesEntries in the catalogue of periodontal probes shall include the designation as spe

40、cified in 4.1. Further information about marking, labelling and catalogue entries is given in ISO 21672-1:2012, Clause 7. ISO 2012 All rights reserved 3BS EN ISO 21672-2:2012ISO 21672-2:2012(E)Table 1 First digit: TypeType DigitNot specified 0Type 1 1Type 2 2Type 3 3Type 4 4Type 5 54.3 Second digit:

41、 Graduated scaleThe second digit refers to the graduated scale of the working end of the periodontal probe as specified in Table 2. Further information about the graduated scale is given in ISO 21672-1:2012, 5.2.1.Table 2 Second digit: Graduated scaleGraduated scale of working endmmDigitNot specifie

42、d 03,5 5,5 8,5 11,5 11 2 3 5 7 8 9 10 23 6 8 11 33 6 9 12 42 4 6 8 10 12 54.4 Third digit: ProfileThe third digit refers to the profile of the working end of the periodontal probe as specified in Table 3. Further information about the profile of the working end is given in ISO 21672-1:2012, 5.2.2 an

43、d Figure 6.Table 3 Third digit: ProfileProfile of working end DigitNot specified 0Spherical end 1Domed end 2Rectangular flat end with rounded corners 34.5 Fourth digit: Colour codingThe fourth digit refers to the colour coding of the working end of the periodontal probe as specified in Table 4.Table

44、 4 Fourth digit: Colour codingColour coding of working end DigitNon-colour coded 0Colour coded 12 ISO 2012 All rights reservedBS EN ISO 21672-2:2012ISO 21672-2:2012(E)5 Marking, labelling and catalogue entries5.1 Marking of periodontal probesPeriodontal probes should be indelibly marked with the des

45、ignation as specified in 4.1. As a minimum requirement, periodontal probes shall be indelibly marked with their pattern name.5.2 Labelling on the primary packaging of periodontal probesThe primary packaging of the periodontal probes should be labelled with the designation as specified in 4.1. As a m

46、inimum requirement, the primary packaging shall be labelled with their pattern name.5.3 Catalogue entriesEntries in the catalogue of periodontal probes shall include the designation as specified in 4.1. Further information about marking, labelling and catalogue entries is given in ISO 21672-1:2012,

47、Clause 7. ISO 2012 All rights reserved 3BS EN ISO 21672-2:2012ISO 21672-2:2012(E)Annex A (informative) Examples of designations for periodontal probesEXAMPLE 1 A Type 1 periodontal probe (WHO PCP 11,5) having a graduated scale of 3,5-5,5-8,5-11,5 mm and a spherical end, and which is colour coded, ha

48、s the designation “1111”.EXAMPLE 2 A Type 2 periodontal probe (Merritt) having a graduated scale of 1-2-3-5-7-8-9-10 mm and a spherical end, and which is non-colour coded, has the designation “2210”.EXAMPLE 3 A Type 3 periodontal probe (Goldman-Fox) having a graduated scale of 1-2-3-5-7-8-9-10 mm an

49、d a spherical end, and which is non-colour coded, has the designation “3210”.EXAMPLE 4 A Type 4 periodontal probe (PCP 11) having a graduated scale of 3-6-8-11 mm and a spherical end, and which is colour coded, has the designation “4311”.EXAMPLE 5 A Type 4 periodontal probe (PCP 12) having a graduated scale of 3-6-9-12 mm and a spherical end, and which is colour coded, has the designation “4411”.4 ISO 2012 All rights reservedBS E