ASTM F621-2002 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

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1、Designation: F 621 02Standard 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 Specifi

3、cation F 138 (UNS S31673), SpecificationF 1314 (UNS S21910), or Specification F 1586 (UNS S31675).1.2 The values stated in inch-pound units are to be regardedas the standard.2. Referenced Documents2.1 ASTM Standards:A 262 Practices for Detecting Susceptibility to Intergranu-lar Attack in Austenitic

4、Stainless Steels2A 473 Specification for Stainless Steel Forgings2E 8 Test Methods for Tension Testing of Metallic Materials3E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials3E 112 Test Methods for Determining Average Grain Size3E 165 Practice for Liquid

5、Penetrant Examination4E 353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys5F 138 Specification for Wrought-18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)6F 601 Practice for Fluo

6、rescent Penetrant Inspection of Me-tallic Surgical Implants6F 1314 Specification for Wrought Nitrogen Strengthened-22Chromium-13Nickel-5Manganese-2.5MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S21910)6F 1586 Specification for Wrought NitrogenStrengthened21Chromium-10Nickel

7、-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants (UNS S31675)62.2 ISO Standards:7ISO 5832-1 Implants for SurgeryMetallic Materials Part1: Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic Materials Part9: Wrought High Nitrogen Stainless Steel2.3 American Society

8、for Quality Standard:Cl Specifications of General Requirements for a QualityControl Program83. Ordering Information3.1 Inquiries and orders for forgings under this specificationshall include the following information:3.1.1 Quantity,3.1.2 ASTM designation and date of issue,3.1.3 ASTM material (alloy)

9、 standard and date of issue,3.1.4 Condition,3.1.5 Mechanical properties,3.1.6 Finish,3.1.7 Applicable dimensions or drawing number,3.1.8 Special tests, if any, and3.1.9 Other special requirements.4. General Requirements for Delivery4.1 Material furnished to this specification shall conform tothe app

10、licable requirements in the current edition of Specifi-cation A 473.4.2 In the case where a conflict exists between this specifi-cation and that listed in 4.1, this specification shall takeprecedence.5. Materials and Manufacture5.1 Material for forgings shall be bars or wire fabricated inaccordance

11、with Specifications F 138, F 1314, or F 1586,generally in the unannealed condition with a finish suitable forforging.5.2 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-workingoperat

12、ion to be in the most favorable direction for resistingstresses encountered in service, as may be indicated to the1This 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 M

13、aterials.Current edition approved Apr. 10, 2002. Published June 2002. Originallypublished as F 621 79. Last previous edition F 621 97.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 03.01.4Annual Book of ASTM Standards, Vol 03.03.5Annual Book of ASTM Standards, Vol 03.0

14、5.6Annual Book of ASTM Standards, Vol 13.01.7Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.8Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.

15、Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.supplier by the purchaser.5.3 Forgings shall be free of splits, scale, cracks, inequali-ties, flaws, and other imperfections not consistent with goodcommercial practice (see Note 1). Off

16、set or mismatch allow-ance, dependent upon part size and configuration, shall bewithin standard forging tolerances.NOTE 1Compliance to these requirements may be verified by Prac-tices E 165 or F 601 or other suitable methods.5.4 After all hot working-operations, the forgings shallreceive an annealin

17、g treatment, 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.5.5 Optional identification marks, including the purchaserslogo, material designatio

18、n, heat code number, and impressionnumber, may be placed upon each forging, the method andlocation of which shall be as specified by the purchaser.6. Chemical Composition6.1 The stainless steel forgings shall conform to the chemi-cal requirements prescribed in the applicable alloy specifica-tion: F

19、138, F 1314, or F 1586.6.2 For referee purposes, Test Methods E 353 shall be used.7. Mechanical Requirements7.1 The mechanical properties of forgings shall be tested bythe forger and shall comply with the minimum mechanicalproperties as specified in Specifications F 138, F 1314, or F1586.7.1.1 Test

20、specimens shall be taken from a representativeforging if possible, or from a representative forged test bar,only if the configuration does not lend itself to yielding therequired specimen. Any specially forged test bar must be in thesame condition as the forgings it represents.7.2 When desired, Rock

21、well hardness may be specified bythe purchaser and shall be determined in accordance with TestMethods E 18.7.3 The mechanical properties shall be determined in accor-dance with Test Methods E 8.8. Special Tests8.1 Corrosion TestsForgings furnished to this specifica-tion shall be capable of passing t

22、he test for intergranularcorrosion susceptibility in accordance with Practice E ofPractices A 262.8.2 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

23、 accordance with Test MethodsE 112.8.3 When specified by the purchaser, fluorescent penetrantinspection shall be performed on forgings. Penetrant inspec-tions shall be performed in accordance with Practice E 165 orPractice F 601.8.4 Other special requirements shall be as specified by thepurchaser.9.

24、 Certification9.1 The suppliers certification that the material was manu-factured and tested in accordance with this specification,together with a report of the test results, shall be furnished tothe purchaser with each shipment.10. Quality Program Requirements10.1 The supplier and any other process

25、or that suppliesmaterial in accordance with this specification shall maintain aquality program as defined in ASQ C1 or equivalent.11. Keywords11.1 forgingssurgical implants; metals (for surgicalimplants)stainless steel; stainless steelsurgical applica-tionsAPPENDIXES(Nonmandatory Information)X1. RAT

26、IONALEX1.1 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 thisspecification represent the current general consensus withrespect to o

27、ptimization 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 beenadded as an appendix.X1.4 ISO standards are listed for refer

28、ence 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 preferred ASTM standardmay be negotiated between purchaser and supplier. In thisspecification, ISO 5832-1 composition D i

29、s similar to ASTMSpecification F 138 and the composition of ISO 5832-9 issimilar to ASTM Specification F 1586.F 6212X2. BIOCOMPATIBILITYX2.1 The material compositions covered by this specifica-tion have been employed successfully in human implantapplications in contact with soft tissue and bone for

30、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 in appropriate applications.SUMM

31、ARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 621 97)that may impact the use of this standard.(1) No significant changes were made to this specification.(2) UNS numbers were updated, titles were corrected, andwording was revised

32、to be in accordance with templatelanguage and other specifications.(3) ISO Standards were added for reference.ASTM 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

33、 that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either rea

34、pproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If yo

35、u feel that your comments have not received 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).F 6213