ASTM F1377-2008 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)《骨科植入物涂层用钴-28铬-6钼粉的标准规范(UNS R30075)》.pdf

1、Designation: F 1377 08Standard 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 () 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 u

3、se 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 co

4、atings formed from them.1.4 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2B 214 Test Method

5、for Sieve Analysis of Metal PowdersB 215 Practices for Sampling Metal PowdersE11 Specification for Wire Cloth and Sieves for TestingPurposesE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF75 Specification for Cobalt

6、-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)2.2 ASQ Standard:3ASQ C1 General Requirements for a Quality Program2.3 ISO Standard:4ISO 9001 Quality Management Standard3. Ordering Information3.1 Inquiries and orders for material under this specificationsha

7、ll 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 Coatings formed from me

8、tallic 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 powders used to fo

9、rm 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 used to manufacture

10、 thepowder shall conform to the chemical analysis set forth inTable 1 of Specification F75.6.2 The product analysis tolerance shall conform to therequirements set forth in Table 2 of Specification F75.6.3 For referee purposes, Test Methods E 354 shall be used.1This specification is under the jurisdi

11、ction 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, 2008. Published October 2008. Originallyapproved in 1992. Last previous edition approved in 2004 as F 1377 04.2F

12、or 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 (ASQ), 600 N. Plan

13、kinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO

14、 Box C700, West Conshohocken, PA 19428-2959, United States.7. Sieve Analysis Requirements7.1 Powder shall be sieved to the customers requirementswith screens conforming to Specification E11. Sieve analysistesting of the sieved powder for conformance to purchasersparticle size range requirements shal

15、l be performed accordingto Test Method B 214. Powder sampling shall be performedaccording to Test Method B 215.8. Cleanliness 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 cleanl

16、iness shall be determined by examining arepresentative sample of the powder. Powder sampling shall beperformed according to Practices 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

17、practice, as agreed upon between purchaserand supplier. No foreign material shall be visible under thesetest conditions.9. Certification9.1 Certification that the material meets the requirements ofthe specification shall be provided by the supplier. A report ofthe test results shall be furnished at

18、the time of shipment.10. Quality Program Requirements10.1 The powder supplier shall maintain a quality program,such as that which is defined in ASQ C1 or ISO 9001, forexample.11. Keywords11.1 coatings, metallic; cobalt alloys (for surgical implants);metals (for surgical implants, cobalt alloys); ort

19、hopedic medi-cal devices (cobalt alloys); porous coatings; powderAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Coatings formed from metallic powders have becomewidely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis. Such coatings havealso been demonstr

20、ated to improve bonding of acrylic cementto prostheses.X1.2 It should be recognized that the heat treatments usedto form porous coatings can create microstructures which aresubstantially different from investment cast F75alloy. Porouscoated implants also exhibit much greater surface area thanmonolit

21、hic implants. For these reasons, the biocompatibilityand corrosion behavior must be characterized on finishedcoatings.X1.3 Pore size and morphology are important factorsinfluencing tissue ingrowth and acrylic penetration of porouscoatings. Particle size and shape are critical to controlling thepore

22、size and morphology in the final coating. Particle size isconventionally controlled by screening. The referenced ASTMstandards allow comparison of powder 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 mo

23、rphology in the final coating.Because these parameters are not directly related to thechemical and physical characteristics of the starting powder,they are not addressed in this specification.X1.5 The requirements for powder cleanliness minimizecontaminants which might adversely affect either the bi

24、ocom-patibility of the finished coatings or the ability to properly bondthe coating during manufacturing. The test method in 8.2 iscommonly used for relatively coarse spherical powders used tofabricate sintered porous coatings. Other types of powders mayrequire different methods for cleanliness char

25、acterization. Thedevelopment and implementation of such methods are theresponsibility of the implant manufacturer.X1.6 Various materials known as processing aids may beadded to the powder to provide enhanced processability, and ifapplicable, the powder supplier shall include this informationon the m

26、aterial certification. Processing aids shall have nodetrimental effect on the corrosion resistance, biocompatibility,or adhesion of the final coating.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact wit

27、h soft tissue and bone for over a decade with awell-characterized level of biological response.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

28、specification has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.F1377082SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1377 04) that may impact the use

29、of this standard. (Approved Oct. 1, 2008.)(1) Added ISO 9001 to Sections 2 and 10.(2) Revised X2.1 to remove reference to F 981; removedF 981 from Referenced Documents.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin t

30、his 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 any time by the responsible technical committee and must

31、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 will receive careful consideration at a meeting of there

32、sponsible 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 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).F1377083