ASTM F621-2012 Standard Specification for Stainless Steel Forgings for Surgical Implants《外科植入物用不锈钢锻件的标准规范》.pdf

1、Designation: F621 12Standard Specification forStainless Steel Forgings for Surgical Implants1This standard is issued under the fixed designation F621; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A num

2、ber in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 Specificati

3、ons F138 (UNS S31673), F1314 (UNSS21910), F1586 (UNS S31675), F2229 (UNS S29108), orF2581 (UNS R56320).1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be u

4、sed independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA473 Specification for Stainless Steel Forgi

5、ngsE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE92 Test Method for Vic

6、kers Hardness of Metallic Materials(Withdrawn 2010)3E112 Test Methods for Determining Average Grain SizeE165 Practice for Liquid Penetrant Examination for GeneralIndustryE353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron AlloysF138 S

7、pecification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 Molybde

8、numStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants (UNS S31675)F2229 Specification for Wrought, Nitrogen Strengthened23Manganese-21Chromiu

9、m-1Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29108)F2581 Specification for Wrought Nitrogen Strengthened11Manganese-17Chromium-3Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29225)IEEE/ASTM SI 10 American National Standard

10、 for MetricPractice2.2 ISO Standards:4ISO 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 SystemsRequirements3. Terminology3.1 Definitions of Terms S

11、pecific 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 for forgings under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM desig

12、nation and date of issue,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2012. Published October 2012. Originallyapprove

13、d in 1979. Last previous edition approved in 2008 as F621 08. DOI:10.1520/F0621-12.2For referenced ASTM 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 pa

14、ge onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCo

15、pyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.1.3 ASTM material (alloy) standard and date of issue,4.1.4 Condition,4.1.5 Mechanical properties,4.1.6 Finish,4.1.7 Applicable dimensions or drawing number,4.1.8 Special tests (if any),

16、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 edition of Specifi-cation A473.5.2 In the case where a conflict exists between this specifi-cation and that listed in 5.1, t

17、his specification shall takeprecedence.6. Materials and Manufacture6.1 Material for forgings shall be bars or wire fabricated inaccordance with Specifications F138, F1314, F1586, F2229,orF2581, generally in the unannealed condition with a finishsuitable for forging.6.2 The material shall be forged b

18、y 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 favorable direction for resistingstresses encountered in service, as may be indicated to thesupplier by the purchaser.6.3 Forging

19、s shall be free of splits, scale, cracks, flaws, andother imperfections not consistent with good commercialpractice (see Note 1). Offset or mismatch allowance, dependentupon part size and configuration, shall be within standardforging tolerances if not specified on the part drawing.NOTE 1Compliance

20、to these requirements may be verified by Prac-tices E165 or F601 or other suitable methods.6.4 After all hot-working operations, the forgings shallreceive an annealing treatment, when necessary, by heating theparts to an appropriate elevated temperature for a specifieddwell time followed by rapid co

21、oling to meet the applicablemetallurgical requirements specified by the purchaser.6.5 Heat treating the alloys specified in SpecificationsF2229 and F2581 in an oxidizing atmosphere results in theformation of a magnetic (ferritic) surface layer on the heat-treated product. This surface layer shall be

22、 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 possible.6.6 Optional identification marks, including the purchaserslogo, material designation, heat code number, and impressionnumber, m

23、ay 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 conform to the chemi-cal requirements prescribed in the applicable alloy specifica-tion: F138, F1314, F1586, F2229,orF2581, as applicab

24、le.7.2 For referee purposes, Test Methods E353 shall be used.8. Mechanical Requirements8.1 The mechanical properties of forgings shall be tested bythe forger and shall comply with the minimum mechanicalproperties as specified in Specifications F138, F1314, F1586,F2229,orF2581, as applicable.8.1.1 Te

25、st 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 cannot be obtained.Any specially forged test bar shall be in the same condition asthe forgings it represents.8.2 When desired, hardness may be

26、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 determined 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 directi

27、on, or as indicated on the part drawing.Should this test result not meet the specified requirements, testtwo additional test pieces representative of the same lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if both additional test piecesmeet the spec

28、ified requirements.8.4.2 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable if boththe elongation and 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 elongati

29、on 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 requirements.9. Special Tests9.1 Corrosion TestsForgings furnished to this specifica-tion shall be capable of passing the test for intergranular

30、corrosion susceptibility in accordance with Practice E ofPractices A262.9.2 Grain SizeOn the cross section examined, the grainsize shall be predominately ASTM No. 4 or finer. No regionsexhibiting grain size larger than ASTM No. 3 shall be allowed.Test procedures shall be in accordance with Test Meth

31、odsE112.9.3 Fluorescent penetrant inspection shall be performed onforgings. Penetrant inspections shall be performed in accor-dance with Practices E165 or F601.9.4 Other special requirements shall be as specified by thepurchaser.10. Dimensions and Permissable Variations10.1 Units of Measure:10.1.1 S

32、electionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection ofF621 122units on the purchase order (PO), this selection may beexpressed by the purchaser in several alternate forms listed inorder

33、 of precedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly changed by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,a

34、nd engineering drawing are consistent, these units shall beused by the supplier for product certification.10.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.10.1.2 Conversion of UnitsIf the suppliers test equipmentdoes

35、 not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI un

36、its. Annex A of that standard provides conversiontables and Annex B provides rules for conversion and signifi-cance.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculate

37、d value shall be rounded to the nearestunit in the last right-hand digit used in expressing the specifi-cation limit, in accordance with the rounding method ofPractice E29.12. Certification12.1 The supplier shall provide a certification that thematerial was tested in accordance with this specificati

38、on andmet all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.13. Quality Program Requirements13.1 The supplier shall maintain a quality program such asdefined in ISO 9001 or similar.14. Keywords14.1 forgingssurgical implants; metals (for surgica

39、limplants)stainless steel; stainless steelsurgical applica-tionsAPPENDIXES(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 microstru

40、ctural requirements contained in thisspecification represent the current general consensus withrespect to optimization of mechanical properties for implantapplications.X1.3 This specification has been expanded to cover forgingsof three specific alloys; each UNS designation has beenincluded for clari

41、fication. A Biocompatibility section has 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 st

42、andardmay be negotiated between purchaser and supplier. In thisspecification, the composition of ISO 5832-1 is similar toASTM Specification F138 and the composition of ISO 5832-9is similar to ASTM Specification F1586.X1.5 Units of Measure:X1.5.1 ASTM PolicyASTM is promoting the use of ratio-nalized

43、SI (metric) units in their standards. The F12.04Committee has modified this specification to facilitate thetransition by the medical materials industry to SI between nowand 2018. In the first phase of this transition, running to 2013,the specifications will be structured to allow the use of either S

44、Ior inch-pound units. The choice of primary units in eachspecification will be determined by the industry using thespecification. The change to SI units during this period may beinitiated by the purchaser through his purchase documentation.In the second phase of this transition, the specifications s

45、hall bewritten with SI as the primary units. Harmonization withcorresponding ISO documents should be considered whenassigning the SI values.F621 123X2. BIOCOMPATIBILITYX2.1 The material compositions covered by this specifica-tion have been employed successfully in human implantapplications in contac

46、t 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 expected, ifthese materials are used

47、in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F621 08)that may impact the use of this standard. (Approved Oct. 1, 2012.)(1) Editorial corrections have been made in order to meetterminology and format

48、ting guidelines established for implantmaterial standards in Subcommittee F04.12.(2) Former wording in 1.2 was replaced with wording allowingindependent SI and inch-pound units.(3) Section 2.1, ASTM Standards, added IEEE/ASTM SI 10,American National Standard for Metric Practice.(4) Former subsection

49、 2.3, ASQ C1 Specification of GeneralRequirements for a Quality Program and former footnote 5were deleted.(5) Section 10, Dimensions and Permissible Variations, wasadded to allow selection of units to be certified.(6) Section 12, Certification, was updated.(7) Reference to ASQ C1 quality program was deleted fromSection 13, Quality Program Requirements.(8) Appendix subsection X1.5 was added to support the use ofSI units.(9) Summary of Changes was updated.ASTM International takes no position respecting the validity of any patent rights asserted in connec