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Ceramic Materials

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Ceramic Materials.

ASTM F1926/F1926M-14(2021)

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.3 The materials may be in the form of powders, granules, spall material, fabricated forms, or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product. 1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 1.6 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. 1.7 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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ASTM F1185-03(2014)

Standard Specification for Composition of Hydroxylapatite for Surgical Implants

1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1 .) 1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3) 2 and by laboratory studies (4-6) . 1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth. 1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.) 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.

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ASTM F1609-08(2014)

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2) 2 and laboratory characterization (2-4) . Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, 3 and applied by methods including, but not limited to, the following: ( 1 ) mechanical capture, ( 2 ) plasma spray deposition, ( 3 ) dipping/sintering, ( 4 ) electrophoretic deposition, ( 5 ) porcelainizing, and ( 6 ) sputtering. 1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 1.6 Warning Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

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ASTM F2224-09(2020)

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form. 1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule. Approximate chemical formulae: 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some provisions of Specification C59/C59M and Test Methods C472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants. 1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use ( 1- 14 ) 2 and by laboratory studies ( 15- 18 ) . 1.7 The following precautionary caveat pertains only to the test method portion, Sections 4 , 5 , and 6 , of this specification. 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.

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ASTM F603-12(2020)

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications. 1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a qualification of the material as delivered to the parts manufacturer. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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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ASTM F1581-08(2020)

Standard Specification for Composition of Anorganic Bone for Surgical Implants

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1 ). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies ( 1 , 2 , 3 ) . 2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host ( 4 ) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use ( 5 , 6 , 7 ) . 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Warning Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 1.6 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. (See Appendix X2 ) . 1.7 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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ASTM F2393-12(2020)

Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

1.1 This specification covers material requirements for high-purity, dense zirconium oxide partially stabilized by magnesium oxide (magnesia partially stabilized zirconia (Mg-PSZ)) for surgical implant applications. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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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ASTM F1088-18

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate ( -TCP) for surgical implant applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1 ). 1.2 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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ASTM F2024-10(2021)

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

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.

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ASTM F1538-03(2017)

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. 1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use ( 1- 12 ) 2 and laboratory studies ( 13- 17 ). 1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite. 1.4 Warning Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.5 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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