DIN EN ISO 9173-1-2017 Dentistry - Extraction forceps - Part 1 General requirements (ISO 9173-1 2016) German version EN ISO 9173-1 2016《牙科 拔牙钳 第1部分 一般要求(ISO 9173-1-2016) 德文版本EN ISO.pdf

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1、March 2017 English price group 9No 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 11.060.25!%bn“2637599www.din.deDIN

2、EN ISO 9173-1Dentistry Extraction forceps Part 1: General requirements (ISO 91731:2016);English version EN ISO 91731:2016,English translation of DIN EN ISO 9173-1:2017-03Zahnheilkunde Extraktionszangen Teil 1: Allgemeine Anforderungen (ISO 91731:2016);Englische Fassung EN ISO 91731:2016,Englische be

3、rsetzung von DIN EN ISO 9173-1:2017-03Mdecine buccodentaire Daviers Partie 1: Exigences gnrales (ISO 91731:2016);Version anglaise EN ISO 91731:2016,Traduction anglaise de DIN EN ISO 9173-1:2017-03SupersedesDIN EN ISO 91731:200609www.beuth.deDocument comprises 14 pagesDTranslation by DIN-Sprachendien

4、st.In case of doubt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 9173-1:2017-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 9173-1:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada)

5、 in collaboration with Technical Committee CEN/TC 055 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-23 AA Dentalmedizinische Instrumente. DIN EN ISO 9173

6、 consists of the following parts, under the general title Dentistry Extraction forceps testing: Part 1: General requirements Part 2: Designation Part 3: Design The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 650

7、8-1 DIN EN ISO 6508-1 ISO 7153-1 DIN EN ISO 7153-1 ISO 17664 DIN EN ISO 17664 Amendments This standard differs from DIN EN ISO 9173-1:2006-09 as follows: a) terms for pincers have been included; b) the maximum overall length has been increased to 200 mm; c) the rockwell hardness has been reduced fro

8、m 42 HRC to 40 HRC; d) the requirement for resistance during reprocessing cycles has been increased to 100 cycles; e) the boiling water test has been deleted. Previous editions DIN 13984: 1975-11 DIN EN ISO 9173-1: 1995-11, 2006-09 lowest valueDIN EN ISO 9173-1:2017-03 3 National Annex NA (informati

9、ve) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test methods DIN EN ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel DIN EN ISO 17664, Sterilization of medical devices Information to be provided by

10、 the manufacturer for the processing of resterilizable medical devices DIN EN ISO 9173-1:2017-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9173-1 November 2016 ICS 11.060.20 Supersedes EN ISO 9173-1:2006English Version Dentistry - Extraction forceps

11、- 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 European Standard was approved by CEN on 20 August 2016. CEN members are bound

12、 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 obtained on application to the CEN

13、-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 the CEN-CENELEC Management Centre ha

14、s 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

15、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brus

16、sels 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 EForeword .4Introduction .51 Scope . 62 Normative references 63 Terms and definitions . 64 Requirements 74.1 Materials . 74.1.1 Component parts and fastening

17、 components . 74.2 Maximum overall length . 74.3 Rockwell hardness . 74.4 Surface finish 74.4.1 All surfaces 74.4.2 Beaks 84.5 Resistance to reprocessing . 84.6 Joint opening/closing force 84.7 Joint movement 85 Test methods .85.1 Visual inspection . 85.2 Resistance to reprocessing . 85.3 Joint open

18、ing/closing force 85.4 Joint movement 86 Marking 9Bibliography .10Contents PageEN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 2European foreword .3European foreword This document (EN ISO 9173-1:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Co

19、mmittee 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 May 2017, and conflicting national standards shall be withdrawn at the latest

20、 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 identifying any or all such patent rights. This document supersedes EN ISO 9173-1:2006. According to the CEN-CENELE

21、C 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icel

22、and, 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 9173-1:2016 has been approved by CEN as EN ISO 9173-1:2016 without any modifica

23、tion. EN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 3 ForewordISO (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

24、. 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 take part in the work. ISO collaborates closely with the Intern

25、ational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the diffe

26、rent 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 to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall

27、 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 ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is

28、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, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technica

29、l 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 third edition cancels and replaces the second edition (ISO 9173-1:2006), which has been technically revised

30、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 consists of the following parts, under the general title Dentistry Extraction forceps: Part 1: General requi

31、rements Part 2: Designation Part 3: DesignEN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 4 IntroductionThis revision of ISO 9173-1 is intended to cover all extraction forceps used in dentistry.EN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 5 1 ScopeThis part of ISO 9173 specifies the general per

32、formance requirements for extraction forceps used in dentistry.2 Normative referencesThe following 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

33、latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry 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 m

34、anufacturer for the processing of resterilizable medical devices3 Terms and definitionsFor the 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

35、which enclose the teeth3.3facial beakbeak that is designed to be in contact with the facial surface 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

36、 lengthdistance from beak tip to pivot centreEN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 63.7fastening 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 stainle

37、ss steel components shall conform 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 d

38、escription of extraction forceps4.3 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

39、extraction forceps, such as those 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

40、 burrs or flash.Test in accordance with 5.1.EN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 74.4.2 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

41、5.1.4.5 Resistance 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

42、 not constitute 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 movementT

43、here shall be no 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 r

44、eprocessingCarry 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, di

45、sinfection and 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 gi

46、ven in 4.6.5.4 Joint movementGrip each handle end between the index finger and thumb of each hand, and apply a force perpendicular to the hinge axis.EN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 8 6 MarkingEach extraction forceps shall be permanently marked with the following information:a) name

47、of manufacturer and/or brand name;b) pattern number;c) lot number;d) ISO 9173 (optional).EN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 9 Bibliography1 ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel2 ISO 9173-2, Dentistry Extraction forceps Part 2: Designation3 ISO 9173-3, Dentistry Extraction forceps Part 3: DesignEN ISO 9173-1:2016 (E) DIN EN ISO 9173-1:2017-03 10