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ASTM-F1185:2009 Edition

ASTM-F1185:2009 Edition

$35.75

F1185-03(2009) Standard Specification for Composition of Hydroxylapatite for Surgical Implants

Published By Publication Date Number of Pages
ASTM 2009 3
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1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.)

1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3) and by laboratory studies (4-6) .

1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.

1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088 .)

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard does not purport to address all of the safety concerns, if any, 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.

PDF Catalog

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

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