1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Implants for surgery - Metallic materialsPart 2: Unalloyed titaniumBS EN ISO 58322:2018National forewordThis British Standard is the UK implementation of EN ISO 58322:2018. It is identical to ISO 58322:2018. It supersed
2、es BS EN ISO 58322:2012, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to in
3、clude all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 94255 6ICS 77.120.50; 11.040.40Compliance with a British Standard cannot confer immunity from legal obliga
4、tions.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 58322:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 5832-2May 2018ICS 11.0
5、40.40 Supersedes EN ISO 58322:2012EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 58322:2018: EAll rights of exploitation in any form and by any means reserved
6、worldwide for CEN national MembersImplants for surgery Metallic materials Part 2: Unalloyed titanium (ISO 58322:2018)Implants chirurgicaux Produits base de mtaux Partie 2: Titane non alli (ISO 58322:2018)Chirurgische Implantate Metallische Werkstoffe Teil 2: Unlegiertes Titan (ISO 58322:2018)This Eu
7、ropean Standard was approved by CEN on 1 March 2018.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. Uptodate lists and bibliographical references conce
8、rning such national standards may be obtained on application to the CENCENELEC 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
9、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, Germ
10、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 5832-2:2018 (E)European forewordThis document (EN ISO 58322:201
11、8) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ 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
12、 by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifyin
13、g any or all such patent rights.This document supersedes EN ISO 58322:2012.According to the CENCENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Den
14、mark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endors
15、ement noticeThe text of ISO 5832-2:2018 has been approved by CEN as EN ISO 5832-2:2018 without any modification.2BS EN ISO 58322:2018ISO 5832-2:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Chemical composition . 15 Microstructure 26 Mechanical properti
16、es 26.1 Tensile properties . 26.2 Bending properties 27 Test methods . 3 ISO 2018 All rights reserved iiiContents PageBS EN ISO 58322:2018ISO 5832-2:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The wo
17、rk 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 nongovernme
18、ntal, 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 described in th
19、e 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 to the possi
20、bility 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 ISO list of
21、 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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to
22、 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.This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 1,
23、 Materials.This fourth edition cancels and replaces the third edition (ISO 58322:1999), which has been technically revised.A list of all parts in the ISO 5832 series can be found on the ISO website.iv ISO 2018 All rights reservedBS EN ISO 58322:2018ISO 5832-2:2018IntroductionNo known surgical implan
24、t material has ever been shown to cause absolutely no adverse reaction in the human body. However, longterm clinical experience of the use of the material referred to in this document has shown that an acceptable level of biological response can be expected when the material is used in appropriate a
25、pplications. ISO 2018 All rights reserved vBS EN ISO 58322:2018This page deliberately left blankImplants for surgery - Metallic materials Part 2: Unalloyed titanium1 ScopeThis document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture
26、 of surgical implants.Six grades of titanium based on tensile strength are listed in Table 2.NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in this document.2 Normative referencesThe following documents ar
27、e referred to in the text in such a way that some or all of their content constitutes requirements 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 643, Steels Microgr
28、aphic determination of the apparent grain sizeISO 68921, Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 7438, Metallic materials Bend testASTM E112, Standard test methods for determining average grain size3 Terms and definitionsNo terms and definitions are listed in
29、 this document.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp4 Chemical compositionThe heat analysis when determined as s
30、pecified in Clause 7 shall conform to the requirements as to chemical composition specified in Table 1. Ingot analysis may be used for reporting all chemical requirements except hydrogen, which shall be determined after the last heat treatment and pickling procedure.INTERNATIONAL STANDARD ISO 5832-2
31、:2018 ISO 2018 All rights reserved 1BS EN ISO 58322:2018ISO 5832-2:2018Table 1 Chemical compositionElement Maximum compositional limitspercent mass fractionGrade 1 ELI Grade 1 Grade 2 Grade 3 Grades 4A and 4BNitrogen 0,012 0,03 0,03 0,05 0,05Carbon 0,03 0,08 0,08 0,08 0,08Hydrogen 0,012 5a0,012 5a0,
32、012 5a0,012 5a0,012 5aIron 0,10 0,20 0,30 0,30 0,50Oxygen 0,10 0,18 0,25 0,35 0,40Titanium Balance Balance Balance Balance BalanceaExcept for billets, for which the maximum hydrogen content shall be 0,010 0 % (mass fraction) and for flat products for which the maximum hydrogen content shall be 0,015
33、 % (mass fraction).5 MicrostructureThe microscopic structure of the titanium in the annealed condition shall be uniform. The grain size, determined as specified in Clause 7, shall be no coarser than grain size No. 5.At a magnification of 100, no inclusions or foreign phases shall be visible. Iron is
34、 a beta phase stabilizer and the allowable iron limits might be sufficient to retain beta phase which is not considered a foreign phase in the microstructure.6 Mechanical properties6.1 Tensile propertiesThe tensile properties of the titanium, determined as specified in Clause 7, shall be in accordan
35、ce with the requirements of Table 2.If any of the test pieces fail within the gauge limits and do not meet specified requirements, two retest pieces shall be tested in the same manner, for each failed test piece. The alloy shall be deemed to comply only if both additional test pieces meet the specif
36、ied requirements.If a test piece fails outside the gauge limits, the test is acceptable if the percentage elongation after fracture meets the requirements. If the percentage elongation after fracture does not meet requirements the test shall be discarded and a retest shall be performed.If any of the
37、 retests fails to meet the appropriate requirements, the product represented shall be deemed not to comply with this document. However, the manufacturer may, if desired, subject the material to heat treatment again and resubmit it for testing in accordance with this document.6.2 Bending propertiesTi
38、tanium sheet and strip, when tested as specified in Clause 7, shall not show any cracking on the outside surface of the test piece.2 ISO 2018 All rights reservedBS EN ISO 58322:2018ISO 5832-2:2018Table 2 Mechanical propertiesGrade ConditionaTensile strengthbYield strength Elongation after fracturecR
39、eduction of AreadMandrel diameter for bend test for sheet and stripeRmRp0,2A Z where t 2 mmwhere 2 mm t 5 mmMPa MPa % % mmminimum minimum minimum minimum1 ELI Annealed 200 140 30 3 t 4 t1 Annealed 240 170 24 30 3 t 4 t2 Annealed 345 275 20 30 4 t 5 t3 Annealed 450 380 18 30 4 t 5 t4A Annealed 550 48
40、3 15 25 5 t 6 t4B Coldworked 680 520 10 6 t 6 taMaximum diameter or thickness equal to 75 mm.bTensile, yield and bending requirements of sheet shall apply to material taken both parallel and perpendicular to the direction of rolling.cGauge length = 5,65 S0or 50 mm, where S0is the original crosssecti
41、onal area, in square millimetres.dReduction of area values have been extracted from ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), with permission from ASTM International. ASTM International owns the copy
42、right of ASTM F6713. A copy of the complete standard can be obtained from ASTM, https:/www.astm.org/.et = thickness of the sheet or strip.7 Test methodsThe test methods to be used in determining conformity to the requirements of this document shall be those given in Table 3.Representative test piece
43、s for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 68921.Table 3 Methods of testRequirement Relevant clause Method of testChemical composition 4 Recognized analytical proceduresGrain size 5 ISO 643 or ASTM E 112Mechanical propertiesTensile str
44、engthYield strengthElongation after fractureReduction of areaBend test6 ISO 68921ISO 68921ISO 68921ISO 68921ISO 7438 Bend the sheet or strip through an angle of at least 105 around a mandrel of the diameter specified in Table 2 ISO 2018 All rights reserved 3BS EN ISO 58322:2018This page deliberately
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