ASTM F 1185 : 2003 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Hydroxylapatite for Surgical Implants
Hardcopy , PDF
29-04-2023
English
26-03-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 13.01, 2015 Defines chemical and crystallographic requirements for hydroxylapatite intended for surgical implants.
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
3
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
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| 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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