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ASTM F2024-10(2021)

(Practice)

Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

SIGNIFICANCE AND USE
3.1 Calcium phosphate coatings have been shown in animal and clinical studies to be biocompatible and to enhance the early attachment of bone to implant surfaces (see Refs. (1-5)).3  
3.2 It is believed that the form of calcium phosphate ceramic and its purity with respect to secondary crystalline phases and amorphous material have an effect on its physical, mechanical, and biological properties. However, no definitive studies of effects on biological properties have been completed. To achieve reproducible clinical results and to permit the determination of the effects of properties of the coating on biological performance, it is essential that the properties of both clinical and experimental materials be well-characterized and consistent.  
3.3 This practice provides procedures for determination of the percentage by weight of the crystalline phases identified as hydroxyapatite, β-TCP, and CaO in plasma-sprayed hydroxyapatite coatings.
SCOPE
1.1 This practice is for the determination, by the Reference Intensity Ratio External Standard Method, of the percent by weight of the crystalline phases, hydroxyapatite (HA), beta-(whitlockite) tricalcium phosphate (β-TCP), and calcium oxide (CaO) in coatings deposited upon metallic substrates by plasma spraying hydroxyapatite.  
1.2 A major component in plasma-sprayed HA coatings other than HA is expected to be amorphous calcium phosphate (ACP). Crystalline components other than HA that may be present include alpha- and beta- (whitlockite) tricalcium phosphates, tetracalcium phosphate (TTCP), calcium oxide, and calcium pyrophosphates. Quantification of the minor crystalline components has proven to be very unreliable due to extreme overlap and confounding of X-ray diffraction peaks. Therefore, this practice addresses the quantification of only HA, β-TCP, and CaO.  
1.3 This practice was developed for plasma-sprayed HA coatings with HA contents of at least 50 % of the total coating. It is recognized that the analysis of the crystalline components uses diffraction from regions of the pattern that also include a small contribution from the amorphous component. However, within the limits of applicability of this practice, the effect of such interference is believed to be negligible.  
1.4 The coating analyzed shall be produced and processed under manufacturing conditions equivalent to those used on the device of interest.  
1.5 This practice requires the use of monochromated copper Kα radiation and flat samples.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
31-Jan-2021
ICS
25.220.99 - Other treatments and coatings
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.13 - Ceramic Materials
Current Stage
Ref Project

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ASTM F2024-10(2021) - Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsASTM F2024-10(2021) - Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
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ASTM F2024-10(2021) - Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2024 − 10 (Reapproved 2021)
Standard Practice for
X-ray Diffraction Determination of Phase Content of Plasma-
1
Sprayed Hydroxyapatite Coatings
This standard is issued under the fixed designation F2024; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This practice is for the determination, by the Reference
mine the applicability of regulatory limitations prior to use.
Intensity Ratio External Standard Method, of the percent by
1.8 This international standard was developed in accor-
weight of the crystalline phases, hydroxyapatite (HA), beta-
dance with internationally recognized principles on standard-
(whitlockite) tricalcium phosphate (β-TCP), and calcium oxide
ization established in the Decision on Principles for the
(CaO)incoatingsdepositeduponmetallicsubstratesbyplasma
Development of International Standards, Guides and Recom-
spraying hydroxyapatite.
mendations issued by the World Trade Organization Technical
1.2 A major component in plasma-sprayed HA coatings
Barriers to Trade (TBT) Committee.
other than HAis expected to be amorphous calcium phosphate
(ACP). Crystalline components other than HA that may be
2. Terminology
present include alpha- and beta- (whitlockite) tricalcium
2.1 Definitions:
phosphates, tetracalcium phosphate (TTCP), calcium oxide,
2.1.1 crystalline phases:
and calcium pyrophosphates. Quantification of the minor
2
Chemical and Mineral Formula PDF Card No.
crystalline components has proven to be very unreliable due to
Names
extreme overlap and confounding of X-ray diffraction peaks.
whitlockite β-Ca (PO ) 9-169
Therefore, this practice addresses the quantification of only 3 4 2
beta-tricalcium phosphate
HA, β-TCP, and CaO.
calcium phosphate α-Ca (PO ) 9-348
3 4 2
1.3 This practice was developed for plasma-sprayed HA
alpha-tricalcium phosphate
coatings with HAcontents of at least 50 % of the total coating.
It is recognized that the analysis of the crystalline components lime CaO 37-1497
calcium oxide
uses diffraction from regions of the pattern that also include a
small contribution from the amorphous component. However,
hydroxyapatite Ca (PO ) OH 9-432
5 4 3
within the limits of applicability of this practice, the effect of (hydroxylapatite)
such interference is believed to be negligible.
2.2 plasma-sprayed hydroxyapatite coating—a coating,
consisting of at least 50 % hydroxyapatite by weight, prepared
1.4 The coating analyzed shall be produced and processed
by plasma spraying hydroxyapatite on a substrate.
undermanufacturingconditionsequivalenttothoseusedonthe
device of interest.
3. Significance and Use
1.5 This practice requires the use of monochromated copper
3.1 Calcium phosphate coatings have been shown in animal
Kα radiation and flat samples.
and clinical studies to be biocompatible and to enhance the
3
1.6 The values stated in SI units are to be regarded as
early attachment of bone to implant surfaces (see Refs. (1-5)).
standard. No other units of measurement are included in this
3.2 It is believed that the form of calcium phosphate
standard.
ceramic and its purity with respect to secondary crystalline
1.7 This standard does not purport to address all of the
phases and amorphous material have an effect on its physical,
safety concerns, if any, associated with its use. It is the
mechanical, and biological properties. However, no definitive
studiesofeffectsonbiologicalpropertieshavebeencompleted.
To achieve reproducible clinical results and to permit the
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
2
Current edition approved Feb. 1, 2021. Published February 2021. Originally Joint Committee on Powder Diffraction Standards, Swarthmore, PA.
3
approved in 2000. Last previous edition approved in 2016 as F2024 – 10 (2016). The boldface numbers in parentheses refer to the list of references at the end of
DOI: 10.1520/F2024-10R21. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2024 − 10 (2021)
determination of the effects of properties of the coating on surface roughness of the alpha-corundum external standa
...

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5.1 Sampling inspection permits the estimation of the overall quality of a group of product articles through the inspection of a relatively small number of product articles drawn from the group.  
5.2 The specification of a sampling plan provides purchasers and sellers a means of identifying the minimum quality level that is considered to be satisfactory.  
5.3 Because sampling plans yield estimates of the quality of a product, the results of the inspection are subject to error. Through the selection of a sampling plan, the potential error is known and controlled.  
5.4 Sampling inspection is used when a decision must be made about what to do with a quantity of articles. This quantity may be a shipment from a supplier, articles that are ready for a subsequent manufacturing operation, or articles ready for shipment to a customer.  
5.5 In sampling inspection, a relatively small number of articles (the sample) is selected randomly from a larger number of articles (the inspection lot); the sample is inspected for conformance to the requirements placed on the articles. Based on the results, a decision is made whether or not the lot conforms to the requirements.  
5.6 Since only a portion of a production lot is inspected, the quality of the uninspected articles is not known. The possibility exists that some of the uninspected articles are nonconforming. Therefore, basic to any sampling inspection plan is the willingness of the buyer to accept lots that contain some nonconforming articles. The number of nonconforming articles in accepted lots is controlled by the size of the sample and the criteria of acceptance that are placed on the sample.  
5.7 Acceptance sampling plans are used for the following reasons:  
5.7.1 When the cost of inspection is high and the consequences of accepting a nonconforming article are not serious.  
5.7.2 When 100 % inspection is fatiguing and boring and, therefore, likely to result in errors.  
5.7.3 When inspection requires a destru...
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4.1 Sampling inspection permits the estimation of the overall quality of a group of product articles through the inspection of a relatively small number of product items drawn from the group.  
4.2 The selection of a sampling plan provides purchasers and sellers a means of identifying the minimum quality levels that are considered to be satisfactory.  
4.3 Because sampling plans will only yield estimates of the quality of a product, the results of the inspection are subject to error. Through the use of sampling plans, the risk of error is known and controlled.
SCOPE
1.1 This guide gives sampling plans that are intended for use in the inspection of metallic and inorganic coatings for conformance to ASTM standard specifications.  
1.2 The plans in this guide, except as noted, have been selected from some of the single sampling plans of MIL-STD-105D. The specific plans selected are identified in Tables 1-3 of this guide. The plan of Table 4, which is used for destructive testing, is not from the Military Standard. This standard does not contain the Military Standard's requirement for tightened inspection when the quality history of a supplier is unsatisfactory.      
1.3 The plans are based on inspection by attributes, that is, an article of product is inspected and is classified as either conforming to a requirement placed on it, or as nonconforming. Sampling plans based on inspection by variables are given in Guide B762. Variables plans are applicable when a test yields a numerical value for a characteristic, when the specification imposes a numerical limit on the characteristic, and when certain statistical criteria are met. These are explained in Guide B762.  
1.4 The plans in this guide are intended to be generally suitable. There may be instances in which tighter or looser plans or ones that are more discriminating are desired. Additional plans that may serve these needs are given in Guide B697. Also, Guide B697 describes the nature of attribute sampling plans and the several factors that must be considered in the selection of a sampling plan. More information and an even greater selection of plans are given in MIL-STD-105D, MIL-STD-414, ANSI/ASQC Z1.9-1979, Refs (1-7)2, and in Guide B697.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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  • Guide
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    English language
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