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ASTM-F1581:1999 Edition

ASTM-F1581:1999 Edition

$35.75

F1581-99 Standard Specification for Composition of Anorganic Bone for Surgical Implants

Published By Publication Date Number of Pages
ASTM 1999 4
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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.

PDF Catalog

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

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