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ASTM F 1185 : 2003 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Available format(s)

Hardcopy , PDF

Superseded date

04-29-2023

Language(s)

English

Published date

03-26-2014

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Defines chemical and crystallographic requirements for hydroxylapatite intended for surgical implants.

1.1This 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.)

1.2The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6) .

1.3This 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.

1.4This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.)

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

1.6This 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.

Committee
F 04
DocumentType
Standard
Pages
3
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2091 : 2015 Standard Specification for Acetabular Prostheses (Withdrawn 2023)
ASTM F 1581 : 2008 : R2016 Standard Specification for Composition of Anorganic Bone for Surgical Implants
ASTM F 1609 : 2008 : R2014 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2502 : 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
ASTM F 1926/F1926M : 2014 Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
ASTM F 1581 : 2008 : R2020 Standard Specification for Composition of Anorganic Bone for Surgical Implants
ASTM F 1926/F1926M : 2014 : R2021 Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

ASTM F 2024 : 2000 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings (Withdrawn 2009)
ASTM F 1088 : 2004 : REV A : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM F 1088 : 2004 : REV A Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ASTM F 2024 : 2010 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 1088:2004 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ASTM F 1088 : 2004 : REV A : R2010 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ASTM F 2024 : 2010 : R2016 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F 2024 : 2010 : R2021 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F 1088 : 1987 : R1992 : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ASTM F 1088 : 2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

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