BS EN ISO 9173-1-2016 Dentistry Extraction forceps General requirements《牙科学 拔牙钳 一般要求和试验方法》.pdf

1、BS EN ISO 9173-1:2016Dentistry Extraction forcepsPart 1: General requirements (ISO9173-1:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 9173-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9173-1:2016.

2、It supersedes BS EN ISO 9173-1:2006 which iswithdrawn.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 pu

3、rport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 85929 8 ICS 11.060.20 Compliance with a British Standard cannot confer immunity from legal obli

4、gations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9173-1 November 2016 ICS 11.060.20 Sup

5、ersedes EN ISO 9173-1:2006English Version Dentistry - Extraction forceps - Part 1: General requirements (ISO 9173-1:2016) Mdecine bucco-dentaire - Daviers - Partie 1: Exigences gnrales (ISO 9173-1:2016) Zahnheilkunde - Extraktionszangen - Teil 1: Allgemeine Anforderungen (ISO 9173-1:2016) This Europ

6、ean Standard was approved by CEN on 20 August 2016. 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 con

7、cerning 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 responsibility of a CEN member i

8、nto 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, Former Yugoslav Republic of Macedonia, France,

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

10、E FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9173-1:2016 EBS EN ISO 9173-1:2016EN ISO 9173-1:2016 (E) 3 European foreword This document (EN I

11、SO 9173-1:2016) 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

12、 or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. 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

13、dentifying any or all such patent rights. This document supersedes EN ISO 9173-1:2006. 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

14、Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, 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.

15、Endorsement notice The text of ISO 9173-1:2016 has been approved by CEN as EN ISO 9173-1:2016 without any modification. BS EN ISO 9173-1:2016ISO 9173-1:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Materials . 24.1.1 Component parts

16、 and fastening components . 24.2 Maximum overall length . 24.3 Rockwell hardness . 24.4 Surface finish 24.4.1 All surfaces 24.4.2 Beaks 34.5 Resistance to reprocessing . 34.6 Joint opening/closing force 34.7 Joint movement 35 Test methods . 35.1 Visual inspection . 35.2 Resistance to reprocessing .

17、35.3 Joint opening/closing force 35.4 Joint movement 36 Marking 4Bibliography 5 ISO 2016 All rights reserved iiiContents PageBS EN ISO 9173-1:2016ISO 9173-1:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodi

18、es). The work of preparing International Standards 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

19、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 electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are desc

20、ribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn t

21、o the possibility 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the

22、ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, a

23、s well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This t

24、hird edition cancels and replaces the second edition (ISO 9173-1:2006), which has been technically revised with the following changes:a) as reprocessing test, only the autoclave test was selected;b) the reprocessing cycles were increased to 100 cycles;c) the boiling water test was deleted.ISO 9173 c

25、onsists of the following parts, under the general title Dentistry Extraction forceps: Part 1: General requirements Part 2: Designation Part 3: Designiv ISO 2016 All rights reservedBS EN ISO 9173-1:2016ISO 9173-1:2016(E)IntroductionThis revision of ISO 9173-1 is intended to cover all extraction force

26、ps used in dentistry. ISO 2016 All rights reserved vBS EN ISO 9173-1:2016BS EN ISO 9173-1:2016Dentistry Extraction forceps Part 1: General requirements1 ScopeThis part of ISO 9173 specifies the general performance requirements for extraction forceps used in dentistry.2 Normative referencesThe follow

27、ing documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistr

28、y VocabularyISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T)ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices3 Terms and definitionsFor the

29、purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1extraction forcepstype of pincers used for the extraction of teeth3.2beakfunctional working end of forceps which enclose the teeth3.3facial beakbeak that is designed to be in contact with the facial sur

30、face of the tooth3.4lingual beakbeak that is designed to be in contact with the lingual surface of the tooth3.5beak separationminimum gap between beak tips with the extraction forceps closed3.6overall beak lengthdistance from beak tip to pivot centreINTERNATIONAL STANDARD ISO 9173-1:2016(E) ISO 2016

31、 All rights reserved 1BS EN ISO 9173-1:2016ISO 9173-1:2016(E)3.7fastening componentscomponent of the extraction forceps used for fastening the pincersEXAMPLE Pins, rivets and screws.4 Requirements4.1 Materials4.1.1 Component parts and fastening componentsAll stainless steel components shall conform

32、to the requirements of 4.2 to 4.6. Examples of suitable stainless steels can be found in ISO 7153-1.4.2 Maximum overall lengthThe maximum overall length of extraction forceps shall not exceed 200 mm.Dimensions in millimetresKey1 beak2 joint3 handleFigure 1 General description of extraction forceps4.

33、3 Rockwell hardnessThe component parts of the extraction forceps, with the exception of the fastening components, shall be heat treated to attain a Rockwell hardness value of 40 HRC to 52 HRC when determined in accordance with ISO 6508-1.Mating surfaces on the same extraction forceps, such as those

34、on opposite beaks, shall not vary in hardness by more than 3 units on the Rockwell hardness scale C.4.4 Surface finish4.4.1 All surfacesAll surfaces shall be free from surface defects and residues and shall also be free from any non-functional sharp edges, including burrs or flash.Test in accordance

35、 with 5.1.2 ISO 2016 All rights reservedBS EN ISO 9173-1:2016ISO 9173-1:2016(E)4.4.2 BeaksWhen the inner or crown space of the extraction forceps is serrated or textured, the serration or texture shall be consistent within any one pattern of extraction forceps.Test in accordance with 5.1.4.5 Resista

36、nce to reprocessingThe extraction forceps shall show no evidence of corrosion and shall comply with all the requirements in this part of ISO 9173 after 100 reprocessing cycles, as recommended by the manufacturer.Test in accordance with 5.2.NOTE Discolouration due to water marking does not constitute

37、 evidence of corrosion.4.6 Joint opening/closing forceThe joint of the extraction forceps shall be so constructed that the extraction forceps opens and closes smoothly.The torque required to operate shall be between 0,20 N m and 0,68 N m.Test in accordance with 5.3.4.7 Joint movementThere shall be n

38、o perceptible sideways movement in any position of the joint between fully closed and a maximum handle opening of 50 mm when tested according to 5.4.5 Test methods5.1 Visual inspectionVisual inspection shall be carried out under normal vision, without magnification.5.2 Resistance to reprocessingCarr

39、y out 100 reprocessing cycles as recommended in the manufacturers instructions, in accordance with ISO 17664. Visually inspect for any signs of corrosion. Retest for requirements as in 4.3 and 4.7. For the purpose of this test, a reprocessing cycle includes the methods of cleaning, disinfection and

40、sterilization.5.3 Joint opening/closing forceMount the extraction forceps in a suitable apparatus to obtain a handle opening of 50 mm. Apply a force just sufficient to close the extraction forceps fully and record the moment of this force.Compare the values obtained with the limits given in 4.6.5.4

41、Joint movementGrip each handle end between the index finger and thumb of each hand, and apply a force perpendicular to the hinge axis. ISO 2016 All rights reserved 3BS EN ISO 9173-1:2016ISO 9173-1:2016(E)6 MarkingEach extraction forceps shall be permanently marked with the following information:a) n

42、ame of manufacturer and/or brand name;b) pattern number;c) lot number;d) ISO 9173 (optional).4 ISO 2016 All rights reservedBS EN ISO 9173-1:2016ISO 9173-1:2016(E)Bibliography1 ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel2 ISO 9173-2, Dentistry Extraction forceps Part 2

43、: Designation3 ISO 9173-3, Dentistry Extraction forceps Part 3: Design ISO 2016 All rights reserved 5This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and servic

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