ASTM-F1581 › Historical Revision Information
Standard Specification for Composition of Anorganic Bone for Surgical Implants
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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 This standard does not pruport 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).
Keywords
allogeneic; anorganic; apatite; bone; hydroxyapatite; hydroxylapatite; implant; xenogeneic; Orthopaedic medical devices--specifications; Orthopaedic medical devices (bone)--specifications; Allogeneic; Anorganic bone; Anorganic hydroxylapatite; Hydroxylapatite (HA); Xenogeneic; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1581-08
Revision Level
2008 EDITION
Status
Superseded
Modification Type
Revision
Publication Date
Feb. 1, 2008
Document Type
Specification
Page Count
4 pages
Committee Number
F04.13