ASTM F1377-2013 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)《骨科植入物覆层用钴-28铬-6钼粉末的标准规范(UNS R30075)》.pdf

1、Designation: F1377 08F1377 13Standard Specification forCobalt-28Chromium-6Molybdenum Powder for Coating ofOrthopedic Implants (UNS R30075)1This standard is issued under the fixed designation F1377; the number immediately following the designation indicates the year oforiginal adoption or, in the cas

2、e of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders

3、 for use in fabricatingcoatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.1.3 This specification covers powder requirements only. It does not address properties of t

4、he coatings formed from them.1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given inparentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in eachsystem may not be e

5、xact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conformance with the standard.2. Referenced Documents2.1 ASTM Standards:2B214 Test Method for Sieve Analysis of Metal PowdersB215 Practices for Sampling Metal Pow

6、dersE11 Specification for Woven Wire Test Sieve Cloth and Test SievesE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysF

7、75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)2.2 ASQ Standard:3ASQ C1 General Requirements for a

8、 Quality Program2.2 ISO Standard:3ISO 9001 Quality Management Standard3. Ordering Information3.1 Inquiries and orders for material under this specification shall include the following information:3.1.1 Quantity,3.1.2 ASTM designation and date of issue,3.1.3 Method of powder manufacturing,3.1.4 Chemi

9、stry requirements,3.1.5 Sieve analysis requirements,1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2008June 1, 2013. P

10、ublished October 2008August 2013. Originally approved in 1992. Last previous edition approved in 20042008 asF1377 04.F1377 08. DOI: 10.1520/F1377-08.10.1520/F1377-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Bo

11、ok of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St.,

12、4th Floor, New York, NY 10036, http:/www.ansi.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accura

13、tely, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor D

14、rive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.6 Special tests, if any, and3.1.7 Other requirements.4. Significance and Use4.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attachment to uncementedorthopedic joint prosthesis. Suc

15、h coatings have also been demonstrated to improve bonding of acrylic cement to prostheses. Thisspecification addresses the special requirements of the metal powders used to form these coatings.5. Materials and Manufacture5.1 Powders may be manufactured by the rotating electrode process, inert gas at

16、omization, or other methods capable ofproducing powder meeting the requirements of this specification.6. Chemical Composition6.1 The heat analysis of stock used to manufacture the powder shall conform to the chemical analysis set forth in Table 1 ofSpecificationSpecifications F75. or F1537 (Alloy 1

17、and Alloy 2 only).6.2 The product analysis tolerance shall conform to the requirements set forth in Table 2 of SpecificationSpecifications F75 orF1537.6.3 For referee purposes, Test Methods E354 shall be used.7. Sieve Analysis Requirements7.1 Powder shall be sieved to the customers requirements with

18、 screens conforming to Specification E11. Sieve analysis testingof the sieved powder for conformance to purchasers particle size range requirements shall be performed according to Test MethodB214. Powder sampling shall be performed according to Test Method B215.8. Cleanliness Requirements8.1 Powder

19、shall be handled at all times so as to minimize possible contamination with nonmetallic materials or other metalalloy powders, or both.8.2 Powder cleanliness shall be determined by examining a representative sample of the powder. Powder sampling shall beperformed according to Practices B215. Powder

20、testing shall be performed by examining either (a) at least 1 in.2 (645 mm2) ofa closely packed mono-layer of powder at 20 , or (b) by an alternative testing practice, as agreed upon between purchaser andsupplier. No foreign material shall be visible under these test conditions.9. Significance of Nu

21、merical Limits9.1 The following applies to all specified numerical limits in this specification. To determine conformance to these limits, anobserved or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit, in accordance with th

22、e Rounding Method of Practice E29.10. Certification10.1 Certification The supplier shall provide a certification that the material meets was manufactured in accordance with therequirements of the specification shall be provided by the supplier. specification. A report of the test results shall be fu

23、rnished tothe purchaser at the time of shipment.11. Quality Program Requirements11.1 The powder supplier shall maintain a quality program, program or quality management system, such as that which isdefined in ASQ C1 or ISO 9001, for example.ISO 9001.12. Keywords12.1 coatings, metallic; cobalt alloys

24、 (for surgical implants); metals (for surgical implants, cobalt alloys); orthopedic medicaldevices (cobalt alloys); porous coatings; powderF1377 132APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attac

25、hment to uncementedorthopedic joint prosthesis. Such coatings have also been demonstrated to improve bonding of acrylic cement to prostheses.X1.2 It should be recognized that the heat treatments used to form porous coatings can create microstructures which aresubstantially different from investment

26、cast F75 alloy. Porous coated implants also exhibit much greater surface area thanmonolithic implants. For these reasons, the biocompatibility and corrosion behavior must be characterized on finished coatings.X1.3 Pore size and morphology are important factors influencing tissue ingrowth and acrylic

27、 penetration of porous coatings.Particle size and shape are critical to controlling the pore size and morphology in the final coating. Particle size is conventionallycontrolled by screening. The referenced ASTM standards allow comparison of powder to a purchasers specifications for a givencoating pr

28、ocess.X1.4 Other process parameters are also critical to determining final pore size and morphology in the final coating. Because theseparameters are not directly related to the chemical and physical characteristics of the starting powder, they are not addressed inthis specification.X1.5 The require

29、ments for powder cleanliness minimize contaminants which might adversely affect either the biocompatibility ofthe finished coatings or the ability to properly bond the coating during manufacturing. The test method in 8.2 is commonly usedfor relatively coarse spherical powders used to fabricate sinte

30、red porous coatings. Other types of powders may require differentmethods for cleanliness characterization. The development and implementation of such methods are the responsibility of theimplant manufacturer.X1.6 Various materials known as processing aids may be added to the powder to provide enhanc

31、ed processability, and ifapplicable, the powder supplier shall include this information on the material certification. Processing aids shall have nodetrimental effect on the corrosion resistance, biocompatibility, or adhesion of the final coating.X1.7 The processing behavior of the powder can be aff

32、ected by variations in the chemical composition of the material, particularlythe carbon content. Sintering and thermal spray practices may need to be modified depending on the chemical composition of thepowder.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specification has been empl

33、oyed successfully in human implant applications incontact with soft tissue and bone for over a decade with a well-characterized level of biological response.X2.2 No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.However, long-term cli

34、nical experience of the use of the material referred to in this specification has shown that an acceptable levelof biological response can be expected, if the material is used in appropriate applications.F1377 133SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this

35、 standard since the last issue(F1377 04F1377 08) that may impact the use of this standard. (Approved Oct. 1, 2008.)June 1, 2013.)(1) Added ISO 9001 toRemoved ASQ C1 from Sections 2 and 1011.(2) Revised Added Section X2.19.1 to remove reference to and added F981E29; removed and F981F1537 from Referen

36、cedtoSection 2Documents(3) Added F1537 Alloy 1 and Alloy 2 to Section 6.(4) Added X1.7.(5) Editorial corrections have been made in order to meet terminology and formatting guidelines established for implant materialstandards.ASTM International takes no position respecting the validity of any patent

37、rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised 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

38、any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved 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

39、will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you 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

40、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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1377 134