ASTM F621-2008 Standard Specification for Stainless Steel Forgings for Surgical Implants《外科植入用不锈钢锻件的标准规范》.pdf

1、Designation: F 621 08Standard Specification forStainless Steel Forgings for Surgical Implants1This standard is issued under the fixed designation F 621; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A n

2、umber in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements of forgedstainless steel for surgical implants when the material forgedconforms to Specific

3、ations F 138 (UNS S31673), F 1314 (UNSS21910), F 1586 (UNS S31675), F 2229 (UNS S29108), orF 2581 (UNS R56320).1.2 The values stated in inch-pound units are to be regardedas the standard.2. Referenced Documents2.1 ASTM Standards:2A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack

4、in Austenitic Stainless SteelsA 473 Specification for Stainless Steel ForgingsE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic Materi-alsE18 Test Methods for Rockwell Hardness of MetallicMaterialsE29 Practice for Using Significant Digits in Te

5、st Data toDetermine Conformance with SpecificationsE92 Test Method for Vickers Hardness of Metallic Mate-rialsE112 Test Methods for Determining Average Grain SizeE 165 Test Method for Liquid Penetrant ExaminationE 353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting, Maraging, and Othe

6、r Similar Chromium-Nickel-Iron AlloysF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 1314 Specification for Wrought Nitrogen Strengthene

7、d 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1586 Specification for Wrought Nitrogen Strengthened 21Chromium10 Nickel3 Manganese2.5 MolybdenumStainless Steel Alloy Bar for Surgical Implants (UNSS31675)F 2229 Specification for

8、Wrought, Nitrogen Strengthened23Manganese-21Chromium-1Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29108)F 2581 Specification for Wrought Nitrogen Strengthened11Manganese-17Chromium-3Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(U

9、NS S29225)2.2 ISO Standards:3ISO 5832-1 Implants for SurgeryMetallic Materials Part1: Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic Materials Part9: Wrought High Nitrogen Stainless SteelISO 9001 Quality Managements SystemsRequirements2.3 American Society for Quality Standard:4ASQ C1

10、 Specifications of General Requirements for aQuality Control Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lotthe total number of forgings produced from thesame heat under the same conditions at essentially the sametime.4. Ordering Information4.1 Inquiries and orders

11、for forgings under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 ASTM material (alloy) standard and date of issue,4.1.4 Condition,4.1.5 Mechanical properties,4.1.6 Finish,1This specification is under the jurisdiction of ASTM C

12、ommittee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 1, 2008. Published February 2008. Originallyapproved in 1979. Last previous edition approved in 2002 as F 621 02.2For referenced A

13、STM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4

14、th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West

15、 Conshohocken, PA 19428-2959, United States.4.1.7 Applicable dimensions or drawing number,4.1.8 Special tests, if any, and4.1.9 Other special requirements.5. General Requirements for Delivery5.1 Material furnished to this specification shall conform tothe applicable requirements in the current editi

16、on of Specifi-cation A 473.5.2 In the case where a conflict exists between this specifi-cation and that listed in 5.1, this specification shall takeprecedence.6. Materials and Manufacture6.1 Material for forgings shall be bars or wire fabricated inaccordance with Specifications F 138, F 1314, F 1586

17、, F 2229,or F 2581, generally in the unannealed condition with a finishsuitable for forging.6.2 The material shall be forged by hammering, pressing,rolling, extruding, or upsetting, and shall be processed, ifpracticable, so as to cause metal flow during the hot-workingoperation to be in the most fav

18、orable direction for resistingstresses encountered in service, as may be indicated to thesupplier by the purchaser.6.3 Forgings shall be free of splits, scale, cracks, flaws, andother imperfections not consistent with good commercialpractice (see Note 1). Offset or mismatch allowance, dependentupon

19、part size and configuration, shall be within standardforging tolerances if not specified on the part drawing.NOTE 1Compliance to these requirements may be verified by Prac-tices E 165 or F 601 or other suitable methods.6.4 After all hot working-operations, the forgings shallreceive an annealing trea

20、tment, when necessary, by heating theparts to an appropriate elevated temperature for a specifieddwell time followed by rapid cooling to meet the applicablemetallurgical requirements specified by the purchaser.6.5 Heat treating the alloys specified in SpecificationsF 2229 and F 2581 in an oxidizing

21、atmosphere results in theformation of a magnetic (ferritic) surface layer on the heat-treated product. This surface layer shall be removed from thefinished product prior to its use as a medical or surgical device.To avoid this effect during processing, heating cycles shall bekept as short as possibl

22、e.6.6 Optional identification marks, including the purchaserslogo, material designation, heat code number, and impressionnumber, may be placed upon each forging, the method andlocation of which shall be as specified by the purchaser.7. Chemical Composition7.1 The stainless steel forgings shall confo

23、rm to the chemi-cal requirements prescribed in the applicable alloy specifica-tion: F 138, F 1314, F 1586, F 2229,orF 2581, as applicable.7.2 For referee purposes, Test Methods E 353 shall be used.8. Mechanical Requirements8.1 The mechanical properties of forgings shall be tested bythe forger and sh

24、all comply with the minimum mechanicalproperties as specified in Specifications F 138, F 1314, F 1586,F 2229,orF 2581, as applicable.8.1.1 Test specimens shall be taken from a representativeforging if possible. A representative test bar may only be usedif the configuration is such that a test bar ca

25、nnot be obtained.Any specially forged test bar must be in the same condition asthe forgings it represents.8.2 When desired, hardness may be specified on the pur-chase order or drawing and shall be determined in accordancewith Test Methods E10, E18,orE92.8.3 The mechanical properties shall be determi

26、ned in accor-dance with Test Methods E8.8.4 Number of Tests:8.4.1 Perform at least one tension test from each lot in thelongitudinal direction, or as indicated on the part drawing.Should this test result not meet the specified requirements, testtwo additional test pieces representative of the same l

27、ot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if both additional test piecesmeet the specified requirements.8.4.2 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable if boththe elongation and

28、reduction of area meet the minimumrequirements specified. Refer to Test Methods E8, sections7.11.4 and 7.12.5.8.4.2.1 If either the elongation or reduction of area is lessthan the minimum requirement, discard the test and retest.Retest one specimen for each specimen that did not meet theminimum requ

29、irements.9. Special Tests9.1 Corrosion TestsForgings furnished to this specifica-tion shall be capable of passing the test for intergranularcorrosion susceptibility in accordance with Practice E ofPractices A 262.9.2 Grain SizeOn the cross section examined, the grainsize shall be predominately ASTM

30、No. 4 or finer. No regionsexhibiting grain size larger thanASTM No. 3 shall be allowed.Test procedures shall be in accordance with Test MethodsE112.9.3 Fluorescent penetrant inspection shall be performed onforgings. Penetrant inspections shall be performed in accor-dance with Practices E 165 or F 60

31、1.9.4 Other special requirements shall be as specified by thepurchaser.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit i

32、n the last right-hand digit used in expressing the specifi-cation limit, in accordance with the rounding method ofPractice E29.11. Certification11.1 The suppliers certification that the material was manu-factured and tested in accordance with this specification,together with a report of the test res

33、ults, shall be furnished tothe purchaser with each shipment.F62108212. Quality Program Requirements12.1 The supplier shall maintain a quality program such asdefined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 forgingssurgical implants; metals (for surgicalimplants)stainless steel; stainless ste

34、elsurgicalapplicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughtstainless steel forgings for surgical implants.X1.2 The microstructural requirements contained in thisspeci

35、fication represent the current general consensus withrespect to optimization of mechanical properties for implantapplications.X1.3 This specification has been expanded to cover forg-ings of three specific alloys; each UNS designation has beenincluded for clarification. A Biocompatibility section has

36、 beenadded as an appendix.X1.4 ISO standards are listed for reference only. Althoughthe ISO standards listed in 2.2 are similar to the correspondingASTM standards, they may not be identical. Use of an ISOstandard in addition to or instead of a preferredASTM standardmay be negotiated between purchase

37、r and supplier. In thisspecification, the composition of ISO 5832-1 is similar toASTM Specification F 138 and the composition of ISO 5832-9is similar to ASTM Specification F 1586.X2. BIOCOMPATIBILITYX2.1 The material compositions covered by this specifica-tion have been employed successfully in huma

38、n implantapplications in contact with soft tissue and bone for over adecade.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term clinical experience has shown anacceptable level of biological response can be expect

39、ed, ifthese materials are used in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 621 02)that may impact the use of this standard.(1) Specifications F 2229 (UNS S29108) and F 2581 (UNSR56320) were added

40、 as applicable stainless steels.(2) Section 3, Terminology, was added, including the definitionof a lot.(3) Section 6.5 was added to warn of the possibility of a ferritelayer at the surface of forgings produced from SpecificationsF 2229 (UNS S29108) or F 2581 (UNS R56320).(4) Section 10, Significanc

41、e of Numerical Limits, was added todefine the appropriate significant digits for all numeric require-ments.(5) Brinell (Test Method E10) and Vickers (Test Method E92)hardness test methods were added as alternatives to theRockwell (Test Methods E18) hardness test method.(6) Section 8.4 was added to c

42、larify the number of test piecesrequired and the retest rules.F621083ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of an

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45、ed a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F621084