ASTM F2224-09(2020)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- Standard No.
- ASTM F2224-09(2020)
- Release Date
- 2020
- Published By
- American Society for Testing and Materials (ASTM)
- Latest
- ASTM F2224-09(2020)
- Scope
- 1.1 This 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 watercontaining solutions to a fabricated calcium sulfate dihydrate form. 1.2 The 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 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some 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. 1.6 The 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). 1.7 The 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. 1.8 This 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 F2224-09(2020) Referenced Document
- ASTM C472 Standard Test Methods for Physical Testing of Gypsum, Gypsum Plasters and Gypsum Concrete
- ASTM C59/C59M Standard Specification for Gypsum Casting Plaster and Gypsum Molding Plaster*， 2020-10-01 Update
- ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
- ASTM F1635 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
- ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants*， 2021-04-01 Update
- ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ASTM F2224-09(2020) history
- 2020 ASTM F2224-09(2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- 2009 ASTM F2224-09(2014) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- 2009 ASTM F2224-09 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- 2003 ASTM F2224-03 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
