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ASTM F2224-09(2014)

(Specification)

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

ABSTRACT
This specification covers unfabricated and fabricated forms of high purity hydrated calcium sulfate hemihydrate or dihydrate for surgical implants. The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules with one water mole but does not include calcium sulfate anhydrite and calcium sulfate forms that contain reinforcing phases, medicaments, biological agents, and other such additives. All covered materials should conform to the requirements for set time, compressive strength, and in vitro degradation.
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 water-containing 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 and health practices and determine the applicability of regulatory requirements prior to use.

General Information

Status
Historical
Publication Date
28-Feb-2014
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.13 - Ceramic Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F2224-09 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Effective Date
01-Mar-2014
Replaced By
ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Effective Date
01-Aug-2020

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ASTM F2224-09(2014) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical ImplantsASTM F2224-09(2014) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
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ASTM F2224-09(2014) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2224 −09 (Reapproved 2014)
Standard Specification for
High Purity Calcium Sulfate Hemihydrate or Dihydrate for
1
Surgical Implants
This standard is issued under the fixed designation F2224; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility
1.1 This specification covers material requirements for un-
of the user of this standard to establish appropriate safety and
fabricated and fabricated forms of hydrated calcium sulfate
health practices and determine the applicability of regulatory
intended for surgical implants. Fabricated forms may include
requirements prior to use.
pressed and cast surgical implants in various geometric shapes.
The calcium sulfate hemihydrate in the unfabricated form can
2. Referenced Documents
be converted with the addition of water or other water-
3
2.1 ASTM Standards:
containing solutions to a fabricated calcium sulfate dihydrate
C59/C59M Specification for Gypsum Casting Plaster and
form.
Gypsum Molding Plaster
1.2 The requirements of this specification apply to calcium
C472 Test Methods for Physical Testing of Gypsum, Gyp-
sulfate combined with two molecules of water or two calcium
sum Plasters and Gypsum Concrete
sulfate molecules sharing one water molecule.
F648 Specification for Ultra-High-Molecular-Weight Poly-
Approximate chemical formulae:
ethylene Powder and Fabricated Form for Surgical Im-
Calcium Sulfate Dihydrate
plants
CaSO ·2H O
4 2
F756 Practice for Assessment of Hemolytic Properties of
Calcium Sulfate Hemihydrate
Materials
CaSO ·1/2H O or CaSO ·H O·CaSO
4 2 4 2 4
F763 Practice for Short-Term Screening of Implant Materi-
1.3 This specification specifically excludes calcium sulfate
als
anhydrite and calcium sulfate forms that contain additives such
F813 Practice for Direct Contact Cell Culture Evaluation of
as reinforcing phases, medicaments, biological agents, and so
Materials for Medical Devices
forth.
F895 TestMethodforAgarDiffusionCellCultureScreening
for Cytotoxicity
1.4 The presence of processing aids does not exclude a
F981 Practice for Assessment of Compatibility of Biomate-
product from the physical and mechanical requirements of this
rials for Surgical Implants with Respect to Effect of
specification.
Materials on Muscle and Bone
1.5 Some provisions of Specification C59/C59M and Test
F1088 Specification for Beta-Tricalcium Phosphate for Sur-
Methods C472 apply. Special requirements that are detailed in
gical Implantation
this specification are included to characterize the material
F1635 Test Method forin vitro Degradation Testing of Hy-
which will be used in surgical implants.
drolytically Degradable Polymer Resins and Fabricated
1.6 Thebiologicalresponsetocalciumsulfateinbonetissue
Forms for Surgical Implants
2
has been well characterized by a history of clinical use (1-14)
2.2 Other Documents:
and by laboratory studies (15-18).
BS 6463-102: 2001 Quicklime, Hydrated Lime and Natural
1.7 The following precautionary caveat pertains only to the Calcium Carbonate—Part 102: Methods for Chemical
4
test method portion, Sections 4, 5, and 6, of this specification. Analysis
1
This specification is under the jurisdiction of ASTM Committee F04 on
3
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.13 on Ceramic Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved March 1, 2014. Published March 2014. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2003. Last previous edition approved in 2009 as F2224 – 09. DOI: the ASTM website.
4
10.1520/F2224-09 (2014). Available from the British Standards Institution, c/o IHS Engineering/IHS
2
The boldface numbers in parentheses refer to the list of references at the end of International, 15 Inverness Way East, Englewood, CO 80112, http://
this standard. www.global.ihs.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2224−09 (2014)
5
US Pharmacopeia XXIV (USP 24) NF-19 concentration should not be higher than 100 ppm. Methods for
6
CFR Title 21, Part 820 Quality System Requirements measuring these trace elements are described in Specification
7
Food Chemical Codex (FCC) F1088 (Coupled Plasma—Atomic Absorption Spectrometry),
8
European Pharm
...

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1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

  • Technical specification
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    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off