ASTM F 2224 : 2009 : R2020
Current
The latest, up-to-date edition.
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Hardcopy , PDF
English
01-08-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
4
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
1.1This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form.
1.2The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule.
Approximate chemical formulae:
| Calcium Sulfate Dihydrate |
| CaSO4·2H2O |
| Calcium Sulfate Hemihydrate |
| CaSO4·1/2H2O or CaSO4·H2O·CaSO4 |
1.3This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth.
1.4The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification.
1.5Some provisions of Specification C59/C59M and Test Methods C472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants.
1.6The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use (1-14)2 and by laboratory studies (15-18).
1.7The following precautionary caveat pertains only to the test method portion, Sections 4, 5, and 6, of this specification. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
| ASTM F 763 : 2022 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| ASTM F 763 : 2004 : R2016 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM F 1635 : 2016 | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 1088 : 2023 | Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices |
| ASTM F 756 : 2008 | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ASTM F 648 : 2014 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ASTM F 981 : 2004 : R2016 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone |
| ASTM F 763 : 1999 | Standard Practice for Short-Term Screening of Implant Materials |
| ASTM F 648 : 2021 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ASTM F 1635 : 2024 | Standard Test Method for <emph type="ital">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 1088 : 2018 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| ASTM F 981 : 2023 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.