ASTM F2224-09

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 C 59/C 59M and Test Methods C 472 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) 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: 31-Aug-2009
• 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

Relations

• Replaces: ASTM F2224-03 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 01-Sep-2009
• Replaced By: ASTM F2224-09(2014) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 01-Mar-2014

Standards Content (Sample)

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
StandardSpecification 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
containing solutions to a fabricated calcium sulfate dihydrate
2.1 ASTM Standards:
form. C59/C59M Specification for Gypsum Casting Plaster and
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
1.4 The presence of processing aids does not exclude a for Cytotoxicity
product from the physical and mechanical requirements of this F981 Practice for Assessment of Compatibility of Biomate-
specification. rials for Surgical Implants with Respect to Effect of
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
test method portion, Sections 4, 5, and 6, of this specification. 4
Analysis
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
3
Subcommittee F04.13 on Ceramic Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2009. Published September 2009. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2003 as F2224 – 03. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2224-09. the ASTM website.
4
2
The boldface numbers in parentheses refer to the list of references at the end of Available from the British Standards Institution, c/o IHS Engineering/IHS
this standard. International, 15 Inverness Way East, Englewood, CO 80112.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2224−09
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 Pharmacopeia the United States Pharmacopeia (USP), European
9
I
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2224–03 Designation: F 2224 – 09
Standard Specification for
High Purity Calcium Sulfate Hemihydrate or Dihydrate for
1
Surgical Implants
This standard is issued under the fixed designation F 2224; 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
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 Therequirementsofthisspecificationapplytocalciumsulfatecombinedwithtwomoleculesofwaterortwocalciumsulfate
molecules sharing one water molecule.
Approximate chemical formulae:
Calcium Sulfate Dihydrate
CaSO ·2H O
4 2
Calcium Sulfate Hemihydrate
CaSO ·1/2H O or CaSO ·H O·CaSO
4 2 4 2 4
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 C 59/C 59M and Test Methods C 472 apply. Special requirements that are detailed in this
specification are included to characterize the material which will be used in surgical implants.
2
1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use(1-14) 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.
2. Referenced Documents
3
2.1 ASTM Standards:
C 59/C 59M Specification for Gypsum Casting Plaster and Gypsum Molding Plaster
C 472 Test Methods for Physical Testing of Gypsum, Gypsum Plasters and Gypsum Concrete
F 648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F 756 Practice for Assessment of Hemolytic Properties of Materials
F 763 Practice for Short-Term Screening of Implant Materials
F 813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F 895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Jan. 10, 2003. Published February 2003.
Current edition approved Sept. 1, 2009. Published September 2009. Originally approved in 2003. Last previous edition approved in 2003 as F 2224 – 03.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
, Vol 04.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2224–09
4
F 1635 Test Method for In Vitro Degradation Testing of Poly(L-lactic acid) Resin and Fabricated Form for Surgical Implants
Test Method for in vitro DegradationTesting of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical
Implants
2.2 Other Documents:
4
BS 6463-102: 2001 Quicklime, Hydrated Lime and Natural Calcium Carbonate—Part 102: Methods for Chemical Analysis
5
US Pharmacopeia XXIV (USP 24) NF-19
...