DIN EN ISO 7153-1-2017 Surgical instruments - Materials - Part 1 Metals (ISO 7153-1 2016) German version EN ISO 7153-1 2016《外科器械 材料 第1部分 金属(ISO 7153-1-2016) 德文版本EN ISO 7153-1-2016》.pdf

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1、February 2017 English price group 11No 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 11.040.30; 77.140.20!%anr“26275

2、79www.din.deDIN EN ISO 7153-1Surgical instruments Materials Part 1: Metals (ISO 71531:2016);English version EN ISO 71531:2016,English translation of DIN EN ISO 7153-1:2017-02Chirurgische Instrumente Werkstoffe Teil 1: Metalle (ISO 71531:2016);Englische Fassung EN ISO 71531:2016,Englische bersetzung

3、von DIN EN ISO 7153-1:2017-02Instruments chirurgicaux Matriaux Partie 1: Mtaux (ISO 71531:2016);Version anglaise EN ISO 71531:2016,Traduction anglaise de DIN EN ISO 7153-1:2017-02SupersedesDIN EN ISO 71531:200102www.beuth.deDocument comprises 21 pagesDTranslation by DIN-Sprachendienst.In case of dou

4、bt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 7153-1:2017-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 7153-1:2016) has been prepared by Technical Committee ISO/TC 170 “Surgical instruments” in collaboration with Technical

5、Committee CEN/TC 55 “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. The DIN Standards corresponding to the Internatio

6、nal Standards referred to in this document are as follows: EN 10088-1 DIN EN 10088-1 ISO 5832-2 DIN EN ISO 5832-2 ISO 5832-3 DIN EN ISO 5832-3 ISO 6507-1 DIN EN ISO 6507-1 ISO 6508-1 DIN EN ISO 6508-1 Amendments This standard differs from DIN EN ISO 7153-1:2001-02 as follows: a) the title has been m

7、odified; b) the Scope has been extended from stainless steels to all metallic materials (e. g. including titanium and titanium alloys); c) the material numbers have been listed according to EN 10088-1:2014; d) new materials have been added, e. g. B. 1.4441, 1.4542, 1.4543; e) for stainless steels, v

8、alues in Vickers and Rockwell hardness are indicated. Previous editions DIN 17442: 1977-10 DIN EN ISO 7153-1: 2001-02 DIN EN ISO 7153-1:2017-02 3 National Annex NA (informative) Bibliography DIN EN 10088-1, Stainless steels Part 1: List of stainless steels DIN EN ISO 5832-2, Implants for surgery Met

9、allic materials Part 2: Unalloyed titanium DIN EN ISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methods DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Pa

10、rt 1: Test methods DIN EN ISO 7153-1:2017-02 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7153-1 October 2016 ICS 11.040.30; 77.140.20 Supersedes EN ISO 7153-1:2000English Version Surgical instruments - Materials - Part 1: Metals(ISO 7153-1:2016) Instru

11、ments chirurgicaux - Matriaux - Partie 1: Mtaux (ISO 7153-1:2016) Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle (ISO 7153-1:2016) This European Standard was approved by CEN on 10 September 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the c

12、onditions 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-CENELEC Management Centre or to any CEN member. This European Standard ex

13、ists 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 has the same status as the official versions. CEN members are the national s

14、tandards 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,

15、 Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE 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 res

16、erved worldwide for CEN national Members. Ref. No. EN ISO 7153-1:2016 EEuropean foreword .31 Scope . 52 Normative references 53 Fields of application of materials 54 Materials 12Annex A (informative) Examples of dental instruments .15Bibliography .17Contents PageDIN EN ISO 7153-1:2017-02 EN ISO 7153

17、-1:2016 (E) 2Foreword .4European foreword This document (EN ISO 7153-1:2016) has been prepared by Technical Committee ISO/TC 170 “Surgical instruments” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the s

18、tatus of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the elements of this document may be the subj

19、ect 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 7153-1:2000. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement

20、 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, Portugal, Romania, Slo

21、vakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7153-1:2016 has been approved by CEN as EN ISO 7153-1:2016 without any modification. DIN EN ISO 7153-1:2017-02 EN ISO 7153-1:2016 (E)3 ForewordISO (the International Organization for Standa

22、rdization) 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 technical committee has been established has the right t

23、o 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 electrotechnical standardization.The procedures use

24、d 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 different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules o

25、f 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 not be held responsible for identifying any or all such patent rights. Details of any patent rights identified

26、 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 information given for the convenience of users and does not constitute an endorsement.For an explanation on the

27、 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 Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for th

28、is document is ISO/TC 170, Surgical instruments.This third edition cancels and replaces the second edition (ISO 7153-1:1991), which has been extended from stainless steels to metals and has been technically revised.It also incorporates the Amendment ISO 7153-1:1991/Amd 1:1999.ISO 7153 consists of th

29、e following parts, under the general title Surgical instruments Materials: Part 1: MetalsDIN EN ISO 7153-1:2017-02 EN ISO 7153-1:2016 (E) 4 1 ScopeThis part of ISO 7153 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those us

30、ed in general surgery, orthopaedics and dentistry.While this part of ISO 7153 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.NOTE When selecting the grade of steel and th

31、e shape, dimensions and delivery conditions of the raw material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design of the instrument or the production facilities of the manufacturer, that are not covered by this part of ISO 7153. For this reason,

32、 it is not intended, nor is it possible, for the information given in this part of ISO 7153 to remove the decision-making responsibility from the instrument manufacturer for selecting an appropriate raw product with suitable properties; nor is it intended to preclude the use of other types of steel

33、in the manufacture of instruments, such as the use of carbon steel for cutting instruments. International Standards for surgical instruments, when published, can be observed when making this decision as they may contain additional or new information to be taken into account when selecting appropriat

34、e steel grades.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 latest edition of the referenced document (inclu

35、ding any amendments) applies.ISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1, Meta

36、llic materials Rockwell hardness test Part 1: Test methodEN 10088-1, Stainless steels Part 1: List of stainless steelsASTM B 265, Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and PlateASTM B 348, Standard Specification for Titanium and Titanium Alloy Bars and Billets3 Fields

37、of application of materialsSince there are different requirements to various surgical instruments, there also have to be different requirements to the materials from which the instruments are manufactured. For this reason, not all of the materials listed within Clause 4 are suited to use in every ty

38、pe of instrument. For most types of surgical instruments, materials are given in Tables 1 to 3 which are known from experience to be suitable for those instruments. Although it might be possible that other materials are also suited to the manufacture of some types of instruments, this is not covered

39、 by this part of ISO 7153.DIN EN ISO 7153-1:2017-02 EN ISO 7153-1:2016 (E)5 Table 1 indicates which stainless steels are commonly used to manufacture various types of standard instruments and instrument components. In the first column, a reference letter is given pointing to the stainless steels spe

40、cified within Table 4. In addition, the second column gives the respective reference letters used within the previous version of this part of ISO 7153. This additional information is only provided as a courtesy for users of this part of ISO 7153 who are familiar with the previous version.DIN EN ISO

41、7153-1:2017-02 EN ISO 7153-1:2016 (E) 6 Table 1 Fields of application Stainless steelRefer-ence letter for Table 4Refe ren ce let ter accor ding to ISO 7153-1: 1991 (with drawn)Surgical instruments Componentseleva-tors/raspa-toriesfor-cepsfor-ceps with wear pro-tec-tion (in-serts or coat-ing)scis-so

42、rsscis-sors with wear pro-tec-tion (in-serts or coat-ing)for-ceps with bow han-dlesfor-ceps with bow han-dles with wear pro-tec-tion (in-serts or coat-ing)bone ron-geursbone cut-ting for-cepslami-nec-tomy ron-geursbra nch for cepscon cho to messcal-pels/knivesre-trac-torsprobeschi sels and gou ges /

43、 cure ttes / bone cure ttesmal-letsnee-dle hold-ersnee-dle hold-ers with wear pro-tec-tion(in-serts or coat-ing)self-re tai ning ret rac tors / ster num-sp rea derssp rin gssolid han-dleshol-low han-dlesscrews /riv-ets/guide pinsa B X X XaXaX XaX X X X X X X X X XaX X Xb A X XaX XaX X X X XaX Xc D X

44、 X XaX X X X X Xde L X X Xf R Xg I X X XaX X X X X Xh H X X XaX X X X X Xi M X X X X Xj N XbXbXbX X Xk Ol P X Xmo X X X X Xp G+S X X X X Xq XaFor instruments with wear protection hardness values are only applicable to the carrier material.bFor bendable shafts.D I N E N I S O 7 1 5 3 - 1 : 2 0 1 7 -

45、0 2 E N I S O 715 3 - 1: 201 6 ( E)7In Table 2, it is indicated which hard metals are commonly used to manufacture various types of standard instruments and instrument components. In the first column, a reference letter is given pointing to the hard metals specified within Table 6.DIN EN ISO 7153-1:

46、2017-02 EN ISO 7153-1:2016 (E) 8 Table 2 Fields of application Hard metalsRefer-ence letter for Table 6Surgical instruments Componentseleva-tors/raspa-toriesfor-cepsfor-ceps with wear pro-tec-tion(in-serts or coat-ing)scis-sorsscis-sors with wear pro-tec-tion(in-serts or coat-ing)for-ceps with bow h

47、an-dlesfor-ceps with bow han-dles with wear pro-tec-tion (in-serts or coat-ing)bone ron-geursbone cut-ting for-cepslami-nec-tomy ron-geursbra nch for cepscon cho to messcal-pels/knivesre-trac-torsprobeschi sels and gou ges /cu ret tes/ bone cure ttesmal-letsneedle hold-ersneedle hold-ers with wear p

48、ro-tec-tion(in-serts or coat-ing)self-re-tain-ing ret rac tors/ ster num-sprea dersspri ngssolid han-dleshollow han-dlesscrews / ri vets / gui de pinsaa Xab X X Xac X X X XD I N E N I S O 7 1 5 3 - 1 : 2 0 1 7 - 0 2 E N I S O 715 3 - 1: 201 6 ( E)9In Table 3, it is indicated which kind of titanium grades or alloys are commonly used to manuf