DIN ISO 5832-9-2008 Implants for surgery - Metallic materials - Part 9 Wrought high nitrogen stainless steel (ISO 5832-9 2007) English version of DIN ISO 5832-9 2008-12《外科植入物 金属材料 .pdf

1、December 2008DEUTSCHE NORM English price group 6No part of this standard 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!$

2、TG“1495736www.din.deDDIN ISO 5832-9Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel (ISO 5832-9:2007)English version of DIN ISO 5832-9:2008-12Chirurgische Implantate Metallische Werkstoffe Teil 9: Geschmiedeter hochaufgestickter nichtrostender Stahl (ISO 5832-9:2

3、007)Englische Fassung DIN ISO 5832-9:2008-12SupersedesDIN ISO 5832-9:2000-08www.beuth.deDocument comprises 9 pagesDIN ISO 5832-9:2008-12 2 National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials”. The responsible German

4、 body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-06 AA Implantat-werkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as follows:

5、 ISO 377 DIN EN ISO 377 ISO 643 DIN EN ISO 643 ISO 3651-2 DIN EN ISO 3651-2 ISO 6892 E DIN EN ISO 6892 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 titanium

6、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 Part 8:

7、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 Amendments This st

8、andard differs from DIN ISO 5832-9:2000-08 as follows: a) Normative references have been updated. b) Table 3 “Mechanical properties of bars” has been extended and includes now the conditions “Medium hard” and “Hard”. Previous editions DIN ISO 5832-9: 2000-08 3 National Annex NA (informative) Bibliog

9、raphy DIN EN ISO 377, Steel and steel products Location and preparation of samples and test pieces for mechanical testing DIN EN ISO 643, Steels Micrographic determination of the apparent grain size DIN EN ISO 3651-2, Determination of resistance to intergranular corrosion of stainless steels Part 2:

10、 Ferritic, austenitic and ferritic-austenitic (duplex) stainless steels Corrosion test in media containing sulfuric acid E DIN EN ISO 6892, Metallic materials Tensile testing Method of testing at ambient temperature DIN EN ISO 10714, Steel and iron Determination of phosphorus content Phosphovanadomo

11、lybdate spectrophotometric method DIN ISO 5832-9:2008-12 Introduction No 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

12、that an acceptable level of biological response can be expected when the material is used in appropriate applications. 4 Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel DIN ISO 5832-9:2008-12 1 Scope This part of ISO 5832 specifies the characteristics of, and co

13、rresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required. NOTE 1 The mechanical properties of a sample obtained from a finished

14、 product made of this alloy can differ from those specified in this part of ISO 5832. NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1. 2 Normative references The following referenced documents are indispensable for the application of this document.

15、For dated references, only the edition cited applies. For undated references, the latest 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 testing ISO 404:1992, Steel and steel p

16、roducts General technical delivery requirements ISO 437, Steel and cast iron Determination of total carbon content Combustion gravimetric method ISO 439, Steel and iron Determination of total silicon content Gravimetric method ISO 629, Steel and cast iron Determination of manganese content Spectroph

17、otometric method ISO 643, Steels Micrographic determination of the apparent grain size ISO 671, Steel and cast iron Determination of sulphur content Combustion titrimetric method ISO 3651-2, Determination of resistance to intergranular corrosion of stainless steels Part 2: Ferritic, austenitic and f

18、erritic-austenitic (duplex) stainless steels Corrosion test in media containing sulfuric acid ISO 4967:1998, Steel Determination of content of nonmetallic inclusions Micrographic method using standard diagrams ISO 6892, Metallic materials Tensile testing at ambient temperature ISO 10714, Steel and i

19、ron Determination of phosphorus content Phosphovanadomolybdate spectrophotometric method 5 DIN ISO 5832-9:2008-12 3 Chemical composition 3.1 Test samples The selection of samples for analysis shall be in accordance with the provisions of ISO 377. 3.2 Cast analysis The cast analysis of the steel when

20、 determined in accordance with Clause 6 shall comply with the relevant chemical composition specified in Table 1. Table 1 Chemical composition Element Mass fraction % Carbon 0,08 max. Silicon 0,75 max.Manganese 2 to 4,25 Nickel 9 to 11 Chromium 19,5 to 22 Molybdenum 2,0 to 3,0 Niobium 0,25 to 0,8 Su

21、lfur 0,01 max. Phosphorus 0,025 max.Copper 0,25 max.Nitrogen 0,25 to 0,5 Iron Balance Residuals Each 0,1 max.Total 0,4 max.4 Microstructure in fully annealed condition 4.1 Grain size The austenitic grain size determined in accordance with Clause 7 shall be no coarser than grain size No. 4. 4.2 Absen

22、ce of delta ferrite The steel shall have a structure free from delta ferrite when examined as described in Table 6. 4.3 Inclusion content The non-metallic inclusion content of steel, determined on representative billet or bar samples from the heat, not exceeding 150 mm thickness, and specified in Cl

23、ause 7, shall not exceed the limits given in Table 2. NOTE General practice is to use electroslag remelted steel to comply with these cleanliness requirements and to give other additional benefits. 6 DIN ISO 5832-9:2008-12 Table 2 Inclusion content limits Inclusion content Type of inclusion Thin Thi

24、ck A Sulfides 1,5 1,5 B Aluminates 2 1,5 C Silicates 2 1,5 D Oxides, globular 2,5 1,5 5 Corrosion resistance The steel shall be capable of passing the intergranular Monypenny Strauss corrosion test specified in Clause 7 when the test piece is heat-treated at 675 C for 1 h and air-cooled prior to the

25、 test. 6 Mechanical properties The tensile properties of the steel in the form of bars, when tested in accordance with Clause 7, shall be in accordance with the requirements of Tables 3, 4 or 5. Should any of the test pieces not meet the specified requirements or break outside the gauge limits, rete

26、sts shall be carried out in accordance with the provisions of 8.3.4.3 of ISO 404:1992. Table 3 Mechanical properties of bars Diameter or thickness Ultimate tensile strength Yield strength 0,2 % offset Elongation d Rm,minRp0,2minAminCondition mm MPa MPa % Annealed u 80 mm 740 430 35 Medium hard u 20

27、mm a1 000 700 20 Hard u 20 mm a1 100 1 000 10 aOther sizes may be furnished by agreement between the producer and the purchaser. 7 DIN ISO 5832-9:2008-12 Table 4 Mechanical properties of wires and rods Diameter Ultimate tensile strength Elongation d Rm,minAminCondition mm MPa % 0,229 d u 0,381 1 340

28、 25 0,381 d u 0,508 By agreement 0,508 d u 0,635 1 040 25 0,635 d u 0,889 1 030 25 Annealed wire 0,889 d 1 020 25 3 1 800 4 3,5 1 740 4 1 600 4 4,5 1 460 5 1 320 6 5,5 1 200 8 Cold-drawn rod 6 1 060 12 Table 5 Mechanical properties of sheet and strip Ultimate tensile strength Yield strength 0,2% off

29、set Elongation RmRp0,2minAminCondition MPa MPa % Annealed 770 465 35 7 Test methods The test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be those given in Table 6. The selection and preparation of samples and test pieces for tensile testing shall

30、 be in accordance with the provisions of ISO 377. 8 DIN ISO 5832-9:2008-12 Table 6 Test Methods Requirements Relevant clause or subclause Test method Chemical composition carbon silicon manganese sulfur phosphorus other elements 3 ISO 437 ISO 439 ISO 629 ISO 671 ISO 10714 Recognised analytical proce

31、dure (ISO methods, where these exist) Grain size 4.1 ISO 643 Absence of delta ferrite 4.2 a) Metallographically prepared specimens in the annealed condition from longitudinal and transverse sections. b) Using recognised techniques, examine the specimen at 100 magnification for the presence or absence of delta ferrite. Inclusion content 4.3 ISO 4967:1998, Method A Corrosion resistance 5 ISO 3651-2 Mechanical properties ultimate tensile strength yield strength elongation 6 ISO 6892, as appropriate to the form of the steel. 9 DIN ISO 5832-9:2008-12