EN ISO 7153-1-2016 en Surgical instruments - Materials - Part 1 Metals《外科器械 金属材料 第1部分 不锈钢》.pdf

1、BS EN ISO 7153-1:2016Surgical instruments MaterialsPart 1: Metals (ISO 7153-1:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 7153-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 7153-1:2016. It supersed

2、es BS EN ISO 7153-1:2001 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/170, Surgical instruments.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the

3、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 88328 6 ICS 11.040.30; 77.140.20 Compliance with a British Standard cannot confer immunity from legal obligations.This B

4、ritish Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 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 7153-1 October 2016 ICS 11.040.30; 77.140.20 Superse

5、des EN ISO 7153-1:2000English Version Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016) Instruments 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

6、 September 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 concerning such national standards may

7、 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 language and notified t

8、o 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, Greece, Hungary, Iceland,

9、 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 CEN-CENELEC Managemen

10、t 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 7153-1:2016 EBS EN ISO 7153-1:2016EN ISO 7153-1:2016 (E) 3 European foreword This document (EN ISO 7153-1:2016) has been prepared

11、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 status of a national standard, either by publication of an identical text or by endorsement, at

12、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 subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or a

13、ll 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 this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,

14、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. Endorsement notice

15、The text of ISO 7153-1:2016 has been approved by CEN as EN ISO 7153-1:2016 without any modification. BS EN ISO 7153-1:2016ISO 7153-1:2016(E)Foreword iv1 Scope . 12 Normative references 13 Fields of application of materials 14 Materials . 8Annex A (informative) Examples of dental instruments .11Bibli

16、ography .13 ISO 2016 All rights reserved iiiContents PageBS EN ISO 7153-1:2016ISO 7153-1:2016(E)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 carri

17、ed 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 non-governmental, in liaison with ISO, also take part in the work. I

18、SO 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 described in the ISO/IEC Directives, Part 1. In particular the different

19、 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 to the possibility that some of the elements of this document may be

20、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 ISO list of patent declarations received (see www.iso.org/patents).A

21、ny 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, as well as information about ISOs adherence to the World Trade Organi

22、zation (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 170, Surgical instruments.This third edition cancels and replaces the second edition (ISO 7153-1:1991), which has been extended

23、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 the following parts, under the general title Surgical instruments Materials: Part 1: Metalsiv ISO 2016 All rights reservedBS EN ISO 7153-1:2016INTERNATI

24、ONAL STANDARD ISO 7153-1:2016(E)Surgical instruments Materials Part 1: Metals1 ScopeThis part of ISO 7153 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.While this pa

25、rt 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 the shape, dimensions and delivery conditions of the raw material

26、 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, it is not intended, nor is it possible, for the information gi

27、ven 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 in the manufacture of instruments, such as the use of carbon st

28、eel 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 appropriate steel grades.2 Normative referencesThe following documents, i

29、n 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 5832-2, Implants for surgery M

30、etallic 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, Metallic materials Rockwell hardness test Part 1: Test methodEN 100

31、88-1, 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 of application of materialsSince there are different requiremen

32、ts 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 type of instrument. For most types of surgical instruments, mater

33、ials 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 by this part of ISO 7153. ISO 2016 All rights reserved 1BS EN

34、ISO 7153-1:2016ISO 7153-1:2016(E)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 specified within Table 4. In addition, the sec

35、ond 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.2 ISO 2016 All rights reservedBS EN ISO 7153-1:2016ISO

36、 7153-1:2016(E)Table1 Fields of application Stainless steelRefer-ence letter for Table4Reference letter according toISO 7153-1:1991(withdrawn)SurgicalinstrumentsComponentseleva-tors/raspa-toriesfor-cepsfor-ceps with wear pro-tec-tion(in-serts or coat-ing)scis-sorsscis-sors with wear pro-tec-tion(in-

37、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-geursbranchforcepsconchotomesscal-pels/knivesre-trac-torsprobeschisels and gouges/curettes/bone curettesmal-letsnee-dle hold-ersnee

38、-dle hold-ers with wear pro-tec-tion(in-serts or coat-ing)self-retaining retractors/sternum-spreadersspringssolid han-dleshol-low han-dlesscrews/riv-ets/guidepinsaBXXXaXaXXaXXXXXXXXXXaXXXbAXXaXXaXXXXXaXXcDXXXaXXXXXXd eLXXXfRXgIXXXaXXXXXXhHXXXaXXXXXXiMXXXXXjNXbXbXbXXXkOlPXXmoXXXXXpG+SXXXXXqXaForinstr

39、uments with wearprotection hardness values are only applicable to the carrier material.bForbendableshafts. ISO 2016 All rights reserved 3BS EN ISO 7153-1:2016ISO 7153-1:2016(E)In Table 2, it is indicated which hard metals are commonly used to manufacture various types of standard instruments and ins

40、trument components. In the first column, a reference letter is given pointing to the hard metals specified within Table 6.4 ISO 2016 All rights reservedBS EN ISO 7153-1:2016ISO 7153-1:2016(E)Table2 Fields of application Hard metalsRefer-ence letter for Table6SurgicalinstrumentsComponentseleva-tors/r

41、aspa-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 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-geursbranch fo

42、rcepsconchotomesscal-pels/knivesre-trac-torsprobeschisels and gouges/curettes/bone curettesmal-letsneedle hold-ersneedle hold-ers with wear pro-tec-tion(in-serts or coat-ing)self-re-tain-ing retractors/sternum-spreadersspringssolid han-dleshollowhan-dlesscrews/rivets/guide pinsaaXabXXXacXXXX ISO 201

43、6 All rights reserved 5BS EN ISO 7153-1:2016ISO 7153-1:2016(E)In Table 3, it is indicated which kind of titanium grades or alloys 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 titaniu

44、m grades or alloys specified within Table 7.6 ISO 2016 All rights reservedBS EN ISO 7153-1:2016ISO 7153-1:2016(E)Table3 Fields of application TitaniumRefer-ence letter for Table7SurgicalinstrumentsComponentseleva-tors /raspa-toriesFor-cepsfor-ceps with wear pro-tec-tion(in-serts or coat-ing)scis-sor

45、sscis-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-geursbranchfor-cepsconchotomesscal-pels/knivesre-trac-torsprobeschis-els and goug-es/cu-rettes

46、/bone cu-rettesmal-letsneedle hold-ersneedle hold-ers with wear pro-tec-tion(in-serts or coat-ing)self-retaining retractors/sternum-spreadersspringssolid han-dleshollowhan-dlesscrews/rivets/guidepinsbaXXbbXXbcXXbdXXbfXXXXXXXXXXXXX ISO 2016 All rights reserved 7BS EN ISO 7153-1:2016ISO 7153-1:2016(E)

47、4 MaterialsIn Table 4, grades of stainless steels commonly used to manufacture various types of surgical instruments are listed. Additionally, hardness values in Rockwell as well as in Vickers are given, where possible.Table 4 Stainless steelReference letter according to Table 1Material number accor

48、ding to EN 100881:2014Material short-term according to EN 100881:2014Hardness in Rockwell (HRC) ISO 6508-1Hardness in Vickers HV5/HV10aISO 6507-1Steel gradeb 1.4006 X12Cr13 35 360 martensitice 1.4016 X6Cr17 N.A. N.A. ferritica 1.4021 X20Cr13 42 - 50 420 - 530 martensiticb 1.4024 X15Cr13 40 - 48 400

49、- 500 martensiticg 1.4028 X30Cr13 49 - 55 510 - 620 martensiticc 1.4034 X46Cr13 50 - 58 530 - 675 martensiticm 1.4037 X65Cr13 57 - 61 650 - 750 martensiticd 1.4057 X20CrNi162 40 - 48 400 - 500 martensitice 1.4104 X14CrMoS17 30 310 martensitice 1.4105 X6CrMoS17 N.A. N.A. ferriticq (1.4108)bX30CrMoN151 54 - 59 590 - 700 martensiticp 1.4109 X70CrMo15 55 - 60 610 - 720 martensiticf 1.4112 X90CrMoV18 52 - 60 545 - 720 martensiticg 1.4116 X50CrMoV15 50 - 58 530 - 675 martensitich 1.4117bX38CrMoV15 50 - 58 530 - 67