8.2Processing aids shall have no detrimental effect on the
corrosion resistance and biocompatibility of the final coating.
9.Certification
9.1Powder shipped under this specification shall be accom-
panied by a certification that includes the following:
9.1.1ASTM designation,
施瓦辛格紧急手术9.1.2Quantity (weight),
9.1.3Method of manufacture,
9.1.4Chemical analysis in accordance with 5.1,
9.1.5Sieve analysis in accordance with 6.1,
9.1.6Powder cleanliness in accordance with 7.2,affluence
9.1.7Special requirements in accordance with 8.1,and 9.1.8Other requirements.10.Quality Program Requirements 10.1The producer shall maintain a quality program,for example,such as defined in ASQ C1.10.2The manufacturer of surgical implants shall be assured of the producer’s quality program for conformance to the intent of ASQ C1or other recognized program.11.Keywords 11.1coatings,metallic;cobalt alloys (for surgical implants);metals (for surgical implants,cobalt alloys);orthopedic medi-cal devices (cobalt alloys);porous coatings;powder
APPENDIXES
(Nonmandatory Information)
X1.RATIONALE
X1.1Coatings formed from metallic powders have becomeknk
widely ud as a means of improving tissue attachment to
uncemented orthopedic joint prosthesis.Such coatings have
also been demonstrated to improve bonding of acrylic cement
to prosthes.
X1.2It should be recognized that the heat treatments ud
to form porous coatings can create microstructures which are
substantially different from investment cast F 75alloy.Porous
如何美白脸部coated implants also exhibit much greater surface area than
monolithic implants.For the reasons,the biocompatibility
and corrosion behavior must be characterized on finished
coatings.
X1.3Pore size and morphology are important factors
influencing tissue ingrowth and acrylic penetration of porous
coatings.Particle size and shape are critical to controlling the
pore size and morphology in the final coating.Particle size is
英语四级多少分通过conventionally controlled by screening.The referenced ASTM and MPIF (Metal Powder Industries Federation)standards allow comparison of powder to a manufacturer’s specifications for a given coating process.X1.4Other process parameters are also critical to deter-mining final pore size and morphology in the final coating.Becau the parameters are not directly related to the chemical and physical characteristics of the starting powder,they are not addresd in this standard.X1.5The requirements for powder cleanliness minimize contaminants which might adverly affect either the
biocom-patibility or the finished coatings or the ability to properly bond the coating during manufacturing.The test method in 7.2is commonly ud for relatively coar spherical powders ud to fabricate sintered porous coatings.Other types of powders may require different methods for cleanliness characterization.The development and implementation of such methods are the responsibility of the implant manufacturer.
X2.BIOCOMPATIBILITY
X2.1The alloy composition,free of processing aids (e
Section 8),covered by this standard has been employed
successfully in human implant applications is contact with soft
tissue and bone for over a decade.Due to the well character-北欧野生风情录
ized level of biological respon exhibited by this alloy,it has
been ud as a control material in Practice F 981.X2.2No known surgical implant material has ever been shown to be completely free of adver reactions in the human body.However,long-term clinica
l experience of the u of the material referred to in this standard has shown that an acceptable level of biological respon can be expected,if the material is ud in appropriate applications.
The American Society for Testing and Materials takes no position respecting the validity of any patent rights asrted in connection
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with any item mentioned in this standard.Urs of this standard are expressly advid that determination of the validity of any such
patent rights,and the risk of 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 and
if not revid,either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional standards
and should be addresd to ASTM Headquarters.Your comments will receive careful consideration at a meeting of the responsibleasian cup
technical committee,which you may attend.If you feel that your comments have not received a fair hearing you should make your
lipstickviews known to the ASTM Committee on Standards,100Barr Harbor Drive,West Conshohocken,PA
leapt
19428.
