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ASTM-F1581:2008 Edition

ASTM-F1581:2008 Edition

$35.75

F1581-08 Standard Specification for Composition of Anorganic Bone for Surgical Implants

Published By Publication Date Number of Pages
ASTM 2008 4
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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).

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Chemical Requirements
Test Specimen Fabrication
Quality Program Requirements
Biocompatibility
Sterilization
3 Keywords
X1. RATIONALE
X1.1
X2. BIOCOMPATIBILITY
X2.1
REFERENCES

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