BS ISO 5832-1-2016 Implants for surgery Metallic materials Wrought stainless steel《外科用植入物 可锻不锈钢金属材料》.pdf

1、BS ISO 5832-1:2016Implants for surgery MetallicmaterialsPart 1: Wrought stainless steelBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 5832-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 5832-1:2016.It supersedes

2、BS ISO 5832-1:2007 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include al

3、l the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 87492 5ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Sta

4、ndard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 5832-1:2016 ISO 2016Implants for surgery Metallic materials Part 1: Wrought stainless steelImplants chirurgicaux Prod

5、uits base de mtaux Partie 1: Acier inoxydable corroyINTERNATIONAL STANDARDISO5832-1Fifth edition2016-07-15Reference numberISO 5832-1:2016(E)BS ISO 5832-1:2016ISO 5832-1:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless ot

6、herwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the addres

7、s below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 5832-1:2016ISO 5832-1:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative refere

8、nces 13 Terms and definitions . 14 Chemical composition . 24.1 Test samples 24.2 Cast analysis 25 Microstructure in the fully annealed condition . 25.1 Grain size 25.2 Microstructure 25.3 Inclusion content. 36 Mechanical properties 36.1 Test pieces . 36.2 Tensile test 36.3 Gauge length 37 Test metho

9、ds . 3Bibliography 6 ISO 2016 All rights reserved iiiContents PageBS ISO 5832-1:2016ISO 5832-1:2016(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

10、 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 non-governmental, in liaison with ISO, also take part in the w

11、ork. 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 the ISO/IEC Directives, Part 1. In particular the dif

12、ferent 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 m

13、ay 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 patent declarations received (see www.iso.org/pate

14、nts).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, as well as information about ISOs adherence to the World Trade

15、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 150, Implants for surgery, Subcommittee SC 1, Materials.This fifth edition cancels and replaces the fourth edition (ISO 58

16、32-1:2007), which has been technically revised. It also incorporates the Technical Corrigendum ISO 5832-1:2007/Cor 1:2008. ISO 5832 consists of the following parts, under the general title Implants for surgery Metallic materials: Part 1: Wrought stainless steel Part 2: Unalloyed titanium Part 3: Wro

17、ught titanium 6-aluminium 4-vanadium alloy Part 4: Cobalt-chromium-molybdenum casting alloy Part 5: Wrought cobalt-chromium-tungsten-nickel alloy Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Part 8: Wrought cob

18、alt-nickel-chromium-molybdenum-tungsten-iron alloy Part 9: Wrought high nitrogen stainless steel Part 11: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloyiv ISO 2016 All rights reserve

19、dBS ISO 5832-1:2016ISO 5832-1:2016(E)IntroductionNo known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 5832 has shown that an acceptable le

20、vel of biological response can be expected when the material is used in appropriate applications.The following definitions apply in understanding how to implement an ISO International Standard and other normative ISO deliverables (TS, PAS, IWA): “shall” indicates a requirement; “should” indicates a

21、recommendation; “may” is used to indicate that something is permitted; “can” is used to indicate that something is possible, for example, that an organization or individual is able to do something.3.3.1 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a requirement as an “expression i

22、n the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted.”3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a recommendation as an “expression in the content of a document conveying th

23、at among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action is deprecated but not prohibited.

24、” ISO 2016 All rights reserved vBS ISO 5832-1:2016BS ISO 5832-1:2016Implants for surgery Metallic materials Part 1: Wrought stainless steel1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical

25、 implants.NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.444

26、1 given in the withdrawn DIN 17443.2 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 refere

27、nced document (including any amendments) applies.ISO 377, Steel and steel products Location and preparation of samples and test pieces for mechanical testingISO 404, Steel and steel products General technical delivery requirementsISO 439, Steel and iron Determination of total silicon content Gravime

28、tric methodISO 629, Steel and cast iron Determination of manganese content Spectrophotometric methodISO 643, Steels Micrographic determination of the apparent grain sizeISO 671, Steel and cast iron Determination of sulphur content Combustion titrimetric methodISO 4967:2013, Steel Determination of co

29、ntent of non-metallic inclusions Micrographic method using standard diagramsISO 6892-1:2016, Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 10714, Steel and iron Determination of phosphorus content Phosphovanadomolybdate spectrophotometric method3 Terms and definiti

30、onsFor the purposes of this document, the following terms and definitions apply.3.1original gauge lengthlength between gauge length marks on the test piece measured at room temperature before the testSOURCE: ISO 6892-1:2016, 3.1.1INTERNATIONAL STANDARD ISO 5832-1:2016(E) ISO 2016 All rights reserved

31、 1BS ISO 5832-1:2016ISO 5832-1:2016(E)4 Chemical composition4.1 Test samplesThe selection of samples for analysis shall be carried out in accordance with ISO 377.4.2 Cast analysisThe cast analysis of the steel when determined in accordance with Clause 6 shall comply with the chemical composition spe

32、cified in Table 1. The molybdenum and chromium contents shall be such that the C value obtained from Formula (1) is not less than 26.C = 3,3wMo+ wCr(1)wherewMois the molybdenum content, expressed as a percentage by mass;wCris the chromium content, expressed as a percentage by mass.Table 1 Chemical c

33、ompositionElement Mass fraction %Carbon 0,030 max.Silicon 1,0 max.Manganese 2,0 max.Phosphorus 0,025 max.Sulfur 0,010 max.Nitrogen 0,10 max.Chromium 17,0 to 19,0 max.Molybdenum 2,25 to 3,00Nickel 13,0 to 15,0Copper 0,50 max.Iron Balance5 Microstructure in the fully annealed condition5.1 Grain sizeTh

34、e austenitic grain size, determined in accordance with Clause 6, shall not be coarser than grain size No. 5.5.2 MicrostructureThe steel shall have a structure free from delta ferrite, chi or sigma phase, when examined in accordance with Clause 6.2 ISO 2016 All rights reservedBS ISO 5832-1:2016ISO 58

35、32-1:2016(E)5.3 Inclusion contentThe non-metallic inclusion content of the steel, determined at finished size after a hot-rolling process stage and in accordance with Clause 6, shall not exceed the limits given in Table 2.NOTE It can be necessary to use vacuum or electroslag melting to produce a ste

36、el complying with these cleanliness requirements.Table 2 Inclusion content limitsType of inclusionInclusion content reference numberThin ThickA Sulfides 1,5 1B Aluminates 1,5 1C Silicates 1,5 1D Oxides, globular 1,5 16 Mechanical properties6.1 Test piecesThe selection and preparation of samples and

37、test pieces for tensile testing shall be in accordance with ISO 377.6.2 Tensile testThe tensile properties of the steel in the form of bars, wires, and sheet and strip, when tested in accordance with Clause 6, shall comply with the values specified in Tables 3, 4 and 5, respectively.Should any of th

38、e test pieces not meet the specified requirements or break outside the gauge limits, retests shall be carried out in accordance with ISO 404.6.3 Gauge lengthOriginal gauge length l0shall be either 5,650S or 50 mm, where S0is defined as the original cross-sectional area in square millimetres. The gau

39、ge length chosen for testing shall be reported with the test results.7 Test methodsThe test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be those given in Table 6. ISO 2016 All rights reserved 3BS ISO 5832-1:2016ISO 5832-1:2016(E)Table 3 Mechanica

40、l properties of barsDiameter or thicknessTensile strength0,2 % proof stress of non-proportional elongationElongation after fracture/ gauge lengthCondition d RmRp0,2Amin. min.mm MPa MPa %Annealed All 490 Rm 690 190 40Cold-worked 22 860 Rm 1 100 690 12Extra-hard 8 1 400 Table 4 Mechanical properties o

41、f wiresDiameter Tensile strengthElongation after fracture/ gauge lengthCondition d RmAmin.mm MPa %Annealed0,025 d 0,13 1 000 300,13 0,65 800 40Cold drawna0,2 d 0,7 1 600 Rm 1 850 0,7 d 1 1 500 Rm 1 750 1 d 1,5 1 400 Rm 1 650 1,5 d 2 1 350 Rm 1 600 aWire ordered in the cold-drawn condition can be sup

42、plied to higher tensile strength levels as specified by the purchaser.Table 5 Mechanical properties of strip and sheetTensile strength0,2 % proof stress of non-proportional elongationElongation after fracture/ gauge lengthCondition RmRp0,2Amin. min.MPa MPa %Annealed 490 Rm 690 190 40Cold worked 860

43、Rm 1 100 690 104 ISO 2016 All rights reservedBS ISO 5832-1:2016ISO 5832-1:2016(E)Table 6 Test methodsParameter Relevant clause or subclause Test methodChemical composition Clause 4silicon ISO 439manganese ISO 629sulfur ISO 671phosphorus ISO 10714other elements Recognized analytical procedures(ISO me

44、thods, where these exist).Grain size 5.1 ISO 643aMicrostructure 5.2 a) Metallographically prepare specimens in the annealed condition from longitudinal and transverse sections.b) Using recognized techniques, examine the specimens at 100 magnification for the presence or absence of delta ferrite and

45、carbides.Inclusion content 5.3 ISO 4967:2013, Method AMechanical properties tensile strength proof stress of non-proportional elongation elongation after fractureClause 6ISO 6892-1aIt is preferred that samples for grain size determination be selected after the last annealing operation and prior to t

46、he final cold-working operation. If samples are selected after a final cold-working operation, transverse specimens should be prepared. ISO 2016 All rights reserved 5BS ISO 5832-1:2016ISO 5832-1:2016(E)Bibliography1 ASTM F138, Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum S

47、tainless Steel Bar and Wire for Surgical Implants (UNS S31673)2 ASTM F139, Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)3 DIN 174431), Rolled and wrought stainless steel products for surgical implants; techn

48、ical delivery conditions1) Withdrawn.6 ISO 2016 All rights reservedBS ISO 5832-1:2016BS ISO 5832-1:2016ISO 5832-1:2016(E) ISO 2016 All rights reservedICS 11.040.40Price based on 6 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other sta

49、ndards-related publications, information and services.BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited.British Standards Institution (BSI)About usWe bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions.The knowledge e