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ASTM F1581-99

Historical Revision

Standard Specification for Composition of Anorganic Bone for Surgical Implants

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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.


SDO ASTM: ASTM International
Document Number F1581
Publication Date Feb. 10, 1999
Language en - English
Page Count 4
Revision Level 99
Supercedes
Committee F04.13
Publish Date Document Id Type View
Feb. 1, 2008 F1581-08E01 Revision
Feb. 1, 2008 F1581-08 Revision
Feb. 10, 1999 F1581-99 Revision
Aug. 1, 2020 F1581-08R20 Reaffirmation
Oct. 1, 2016 F1581-08R16 Reaffirmation
Oct. 1, 2012 F1581-08R12 Reaffirmation