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ASTM F 1581 : 1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Specification for Composition of Anorganic Bone for Surgical Implants

Superseded date

11-11-2014

Superseded by

ASTM F 1581:2008

Published date

10-02-1999

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Committee
F 04
DocumentType
Standard
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

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.

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

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