ASTM F1377-2004 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)《矫形外科植入物覆层用钴-28铬-6钼粉末标准规范》.pdf

1、Designation: F 1377 04Standard Specification forCobalt-28Chromium-6Molybdenum Powder for Coating ofOrthopedic Implants (UNS R30075)1This standard is issued under the fixed designation F 1377; the number immediately following the designation indicates the year oforiginal adoption or, in the case of r

2、evision, the year of last revision. A number 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 for cobalt-28chromium-6molybdenum alloy powders for

3、use in fabricat-ing coatings on cobalt-28chromium-6molybdenum alloy ortho-pedic implants.1.2 Powders covered under this specification may be used toform coatings by sintering or thermal spraying techniques.1.3 This specification covers powder requirements only. Itdoes not address properties of the c

4、oatings formed from them.1.4 The values stated in inch-pound units are to be regardedas the standard. The SI units given in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:2B 214 Test Method for Sieve Analysis of Metal PowdersB 215 Practices for Sampling Finished Lots o

5、f Metal Pow-dersE 11 Specification for Wire Cloth and Sieves for TestingPurposesE 354 Test Methods for Chemical Analysis of High Tem-perature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF 75 Specification for Cobalt-28Chromium-6MolybdenumCastings and Casting Alloy for Surg

6、ical Implants (UNSR30075)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ASQ Standards:C1 General Requirements for a Quality Program33. Ordering Information3.1 Inquiries and orders for material under this

7、specificationshall 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 Chemistry requirements,3.1.5 Sieve analysis requirements,3.1.6 Special tests, if any, and3.1.7 Other requirements.4. Significance and Use4.1 Coating

8、s formed from metallic powders have becomewidely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis. Such coatings havealso been demonstrated to improve bonding of acrylic cementto prostheses. This specification addresses the special require-ments of the metal po

9、wders used to form these coatings.5. Materials and Manufacture5.1 Powders may be manufactured by the rotating electrodeprocess, inert gas atomization, or other methods capable ofproducing powder meeting the requirements of this specifica-tion.6. Chemical Composition6.1 The heat analysis of stock use

10、d to manufacture thepowder shall conform to the chemical analysis set forth inTable 1 of Specification F 75.6.2 The product analysis tolerance shall conform to therequirements set forth in Table 2 of Specification F 75.6.3 For referee purposes, Test Methods E 354 shall be used.1This specification is

11、 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, 2004. Published October 2004. Originallyapproved in 1992. Last previous edition approved in 19

12、98 as F 1377 98a.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 page onthe ASTM website.3Available from American Society for Quality

13、 (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7. Sieve Analysis Requirements7.1 Powder shall be sieved to the cust

14、omers requirementswith screens conforming to Specification E 11. Sieve analysistesting of the sieved powder for conformance to purchasersparticle size range requirements shall be performed accordingto Test Method B 214. Powder sampling shall be performedaccording to Test Method B 215.8. Cleanliness

15、Requirements8.1 Powder shall be handled at all times so as to minimizepossible contamination with nonmetallic materials or othermetal alloy powders, or both.8.2 Powder cleanliness shall be determined by examining arepresentative sample of the powder. Powder sampling shall beperformed according to Pr

16、actices B 215. Powder testing shallbe performed by examining either (a) at least 1 in.2(645 mm2)of a closely packed mono-layer of powder at 203 ,or(b)byanalternative testing practice, as agreed upon between purchaserand supplier. No foreign material shall be visible under thesetest conditions.9. Cer

17、tification9.1 Certification that the material meets the requirements ofthe specification shall be provided by the supplier. A report ofthe test results shall be furnished at the time of shipment.10. Quality Program Requirements10.1 The powder supplier shall maintain a quality program,such as that wh

18、ich is defined in ASQ C1.11. Keywords11.1 coatings, metallic; cobalt alloys (for surgical implants);metals (for surgical implants, cobalt alloys); orthopedic medi-cal devices (cobalt alloys); porous coatings; powderAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Coatings formed from metallic p

19、owders have becomewidely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis. Such coatings havealso been demonstrated to improve bonding of acrylic cementto prostheses.X1.2 It should be recognized that the heat treatments usedto form porous coatings can create mi

20、crostructures which aresubstantially different from investment cast F 75 alloy. Porouscoated implants also exhibit much greater surface area thanmonolithic implants. For these reasons, the biocompatibilityand corrosion behavior must be characterized on finishedcoatings.X1.3 Pore size and morphology

21、are important factorsinfluencing tissue ingrowth and acrylic penetration of porouscoatings. Particle size and shape are critical to controlling thepore size and morphology in the final coating. Particle size isconventionally controlled by screening. The referenced ASTMstandards allow comparison of p

22、owder to a purchasers speci-fications for a given coating process.X1.4 Other process parameters are also critical to deter-mining final pore size and morphology in the final coating.Because these parameters are not directly related to thechemical and physical characteristics of the starting powder,t

23、hey are not addressed in this specification.X1.5 The requirements for powder cleanliness minimizecontaminants which might adversely affect either the biocom-patibility of the finished coatings or the ability to properly bondthe coating during manufacturing. The test method in 8.2 iscommonly used for

24、 relatively coarse spherical powders used tofabricate sintered porous coatings. Other types of powders mayrequire different methods for cleanliness characterization. Thedevelopment and implementation of such methods are theresponsibility of the implant manufacturer.X1.6 Various materials known as pr

25、ocessing aids may beadded to the powder to provide enhanced processability, and ifapplicable, the powder supplier shall include this informationon the material certification. Processing aids shall have nodetrimental effect on the corrosion resistance, biocompatibility,or adhesion of the final coatin

26、g.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone for over a decade. Due tothe well characterized level of biological response exhibited bythis alloy, it has been used as a co

27、ntrol material in Practice F981.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 of the use of thematerial referred to in this specification has shown that anacceptable level of biological r

28、esponse can be expected, if thematerial is used in appropriate applications.F1377042SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1377 98a) that may impact the use of this standard. (Approved Oct. 1, 2004.)(1) Changed portions

29、 of this specification to use more techni-cally correct wording for the processing and testing of metalpowders.(2) Made changes to Section 8 so that it complied withRationale section X1.5.(3) Modified this specification to incorporate the standardformat (template) used by Subcommittee F04.12.(4) Mad

30、e editorial corrections in order to meet terminology andformatting guidelines established for implant material stan-dards.(5) Moved previous Section 8 from this specification to besubsection X1.6 of the Rationale section. This change wasmade because this specification applies only to the alloypowder

31、 and not to combination of powder and processing aids.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 that determination of the validity of any such patent r

32、ights, 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 reapproved or withdrawn. Your comments are invited either f

33、or 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 you feel that your comments have not received a fair heari

34、ng 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).F1377043