ASTM F1581-99
Historical Standard: ASTM F1581-99 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SUPERSEDED (see Active link, below)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 (hydroxylapatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix XI).
1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1, 2, 3, 4, 5) and by laboratory studies (6, 7, 8). Xenogeneic bone, due to its organic component, has been shown to be antigenic in the human host (9) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (10, 11).
1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.
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/F1581-99
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