ASTM F1581-08e1
Historical Standard: ASTM F1581-08e1 Standard Specification for Composition of Anorganic Bone for Surgical Implants
SUPERSEDED (see Active link, below)
ASTM F1581
1. Scope
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) . 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 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 standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, 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. (See Appendix X2).
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
D513 Test Methods for Total and Dissolved Carbon Dioxide in Water
D1688 Test Methods for Copper in Water
D2972 Test Methods for Arsenic in Water
D3557 Test Methods for Cadmium in Water
D3559 Test Methods for Lead in Water
D3919 Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D4129 Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection
E1184 Practice for Determination of Elements by Graphite Furnace Atomic Absorption Spectrometry
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
National Formulary
TribasicCalciumPhospKeywords
allogeneic; anorganic; apatite; bone; hydroxyapatite; hydroxylapatite; implant; xenogeneic ;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1581-08E01
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