1、April 2017 English price group 8No 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 11.040.40; 77.140.20!%cO*“2644407ww
2、w.din.deDIN ISO 5832-1Implants for surgery Metallic materials Part 1: Wrought stainless steel (ISO 58321:2016),English translation of DIN ISO 5832-1:2017-04Chirurgische Implantate Metallische Werkstoffe Teil 1: Nichtrostender Stahl (ISO 58321:2016),Englische bersetzung von DIN ISO 5832-1:2017-04Impl
3、ants chirurgicaux Produits base de mtaux Partie 1: Acier inoxydable corroy (ISO 58321:2016),Traduction anglaise de DIN ISO 5832-1:2017-04SupersedesDIN ISO 58321:200812www.beuth.deDocument comprises 12 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be con
4、sidered authoritative.03.17 A comma is used as the decimal marker. National Annex NA (informative) Bibliography 5Introduction .61 Scope . 72 Normative references 73 Terms and definitions . 74 Chemical composition . 84.1 Test samples 84.2 Cast analysis 85 Microstructure in the fully annealed conditio
5、n . 85.1 Grain size 85.2 Microstructure 85.3 Inclusion content. 96 Mechanical properties 96.1 Test pieces . 96.2 Tensile test 96.3 Gauge length 97 Test methods .9Bibliography .12Contents PageNational foreword 3DIN ISO 5832-1:2017-04 2 National foreword This standard (ISO 5832-1:2016) has been prepar
6、ed by Technical Committee ISO/TC 150 “Implants for surgery”, SC 1 “Materials”. The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-06 AA Implantatwerkstoffe. Atten
7、tion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard ar
8、e as follows: ISO 377 DIN EN ISO 377 ISO 439 DIN EN ISO 439 ISO 643 DIN EN ISO 643 ISO 6892-1 DIN EN ISO 6892-1 ISO 10714 DIN EN ISO 10714 DIN ISO 5832 consists of the following parts, under the general title Implants for surgery Metallic materials: Part 1: Wrought stainless steel Part 2: Unalloyed
9、titanium Part 3: Wrought 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
10、 Part 8: Wrought cobalt-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 alloy DIN ISO 5
11、832-1:2017-04 3 Amendments This standard differs from DIN ISO 5832-1:2008-12 as follows: a) Clause 3 “Terms and definitions” and the term “original gauge length” from ISO 6892-1 have been added; b) Subclause 6.3 “Gauge length” has been revised so that the user of the standard has the possibility to
12、choose between different original gauge lengths; c) Tables 4 and 7 which showed the relation between gauge length and product type and between gauge length and thickness of the products have been deleted; d) in Table 6, ISO 437 as test method for carbon has been deleted as the standard has been with
13、drawn without replacement. Previous editions DIN 17443: 1977-10, 1986-04 DIN EN ISO 5832-1: 2000-08, 2008-12 DIN ISO 5832-1:2017-04 4 National Annex NA (informative) Bibliography DIN EN ISO 377, Steel and steel products Location and preparation of samples and test pieces for mechanical testing DIN E
14、N ISO 439, Steel and iron Determination of total silicon content Gravimetric method DIN EN ISO 643, Steels Micrographic determination of the apparent grain size DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature DIN EN ISO 10714, Steel and iron Determina
15、tion of phosphorus content Phosphovanadomolybdate spectrophotometric method DIN ISO 5832-1:2017-04 5 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 refe
16、rred to in this part of ISO 5832 has shown that an acceptable level 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, P
17、AS, IWA): “shall” indicates a requirement; “should” indicates a 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
18、 (sixth edition, 2011) defines a requirement as an “expression in 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 recommenda
19、tion as an “expression in the content of a document conveying that 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 p
20、ossibility or course of action is deprecated but not prohibited.”DIN ISO 5832-1:2017-04 6Implants 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 ma
21、nufacture of surgical 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 an
22、d to alloy code 1.4441 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
23、edition of the referenced 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 si
24、licon content Gravimetric 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, Stee
25、l Determination of content 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 metho
26、d3 Terms and definitionsFor 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, 3.1.1DIN ISO 5832-1:2017-04 7 4 Chemical composition4.
27、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 N1)shall comply with the chemical composition specified in Table 1. The molybdenum and chromium contents sha
28、ll 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 compositionElement Mass fraction %Carbon 0,030 max.Silicon 1
29、,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 sizeThe austenitic grain size, determined in accordance with Clau
30、se 6 , N1)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 .DIN ISO 5832-1:2017-04 8N1) National footnote: In the ISO standard, Clause 6 is indicated instead of Clause
31、7 which is correct for tests. N1)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 me
32、lting to produce a steel 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 prepa
33、ration of samples and 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, respec
34、tively.Should any of the test pieces not meet the specified requirements or break outside the gauge limits, retests shall be carried out in accordance with ISO 404.6.3Gauge lengthOriginal gauge length l0shall be either 5,650S or 50 mm, where S0is defined as the original cross-sectional area in squar
35、e millimetres. The gauge 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.DIN ISO 5832-1:2017-04 9N1)N1)Table 3 Mechanical properties of
36、 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 of wiresDiameter
37、 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 supplied to higher
38、 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 Rm 1 100 690 10
39、DIN ISO 5832-1:2017-04 10 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 methods, where these exist).Grain size 5.1 ISO 643aMicros
40、tructure 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 carbides.Inclusion content 5.3 ISO 4967:2013, Method AM
41、echanical 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 the final cold-working operation. If samples are selecte
42、d after a final cold-working operation, transverse specimens should be prepared.DIN ISO 5832-1:2017-04 11N2) N2) National footnote: In the ISO standard, four subclauses have erroneously been listed. The term “elongation” should not have its own bullet point as “proof stress of non-proportional elong
43、ation” is one concept, as in the following part of the document. For this reason, in the German translation there are only three bullet points. Bibliography1 ASTM F138, Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31
44、673)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; technical delivery conditions1) Withdrawn.DIN ISO 5832-1:2017-04 12
