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.
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Designation:F2224 −09 (Reapproved 2014)
Standard Specification for
High Purity Calcium Sulfate Hemihydrate or Dihydrate for
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-
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
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. Analysis
This specification is under the jurisdiction of ASTM Committee F04 on
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.
10.1520/F2224-09 (2014). Available from the British Standards Institution, c/o IHS Engineering/IHS
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
F2224−09 (2014)
US Pharmacopeia XXIV (USP 24) NF-19 concentration should not be higher than 100 ppm. Methods for
CFR Title 21, Part 820 Quality System Requirements measuring these trace elements are described in Specification
Food Chemical Codex (FCC) F1088 (Coupled Plasma—Atomic Absorption Spectrometry),
European Pharmacopeia the United States Pharmacopeia (USP), European
ISO 10993-1 Biological Evaluation of Medical Devices Pharmacopeia, or Food Chemical Codex (FCC). A second
method that may be used to analyze acid insoluble impurities
3. Terminology
is described in BS 6463-102.
4.2.1 When calcium sulfate dihydrate is converted into
3.1 Definitions:
calcium sulfate hemihydrate, the mass of the material is
3.1.1 calcium sulfate anhydrite—a chemical substance hav-
reducedbyapproximately15 %duetodehydration.Depending
ing approximate molecular formula of CaSO .
on the conversion process, the quantities (total mass) of most
3.1.2 calcium sulfate dihydrate—a chemical having the
or all of the trace elements present in the dihydrate are not
approximate molecular formula of CaSO ·2H O. This sub-
4 2
affected. Therefore, the concentration of those trace elements
stance is also known as gypsum.
in the resulting hemihydrate material can be expected to
3.1.3 calcium sulfate hemihydrate—a chemical substance
increase by approximately 15 %. This should be taken into
having approximate molecular formula of CaSO ·1/2HOor
4 2
account when setting acceptance criteria for a calcium sulfate
CaSO ·H O·CaSO . The mineral name of this substance is
4 2 4
dihydrate raw material that will be used to produce a hemihy-
bassanite and the substance is also known as Plaster of Paris in
drate final product that is expected to conform to this specifi-
the clinical literature.
cation.
3.1.4 processing aids—any constituent intentionally used in
5. Physical and Mechanical Characterization
the processing of the raw material to fulfill a certain techno-
logical purpose during treatment or processing. Some ex-
5.1 The following physical and mechanical characterization
amples would be: binders, lubricants, compaction aids,
may be applicable to calcium sulfate for surgical implant
disintegrants, plasticizers, deflocculants, wetting agents, water
applications in either the fabricated form or intra-operative
retention agents, antistatic agents, antifoam agents, foam
fabricated form.When characterization test results are reported
stabilizers, chelating or sequestering agents, phase stabilizers,
in labeling, the test methods associated with these results shall
and so forth.
be referenced. Labeling can be defined as but is not limited to
3.1.4.1 Discussion—Use of a processing aid may result in the product label, brochures, technical monographs, and other
the unintentional but technically unavoidable presence of
related documentation.
residues of the substance or its derivatives in the final product.
5.2 Set Time—If set time is an applicable property, it should
3.1.5 set time—foramixtureofcalciumsulfatehemihydrate
be reported along with the method by which it was determined
and an aqueous solution, set time is defined as the elapsed time
in order to inform the final user. Test Methods C472 as
between the onset of mixing and the development of sufficient
described in Specification C59/C59M can be used to define a
mechanical properties to meet a specific criteria (for example,
typical set time. The actual method used for set time determi-
hardness or resistance to indentation).
nation shall be described or referenced in labeling.
5.3 Compressive Strength—Calcium sulfate dihydrate in a
4. Chemical Requirements
fabricated final form is intended to be used in non-load bearing
4.1 Calcium sulfate for surgical implants (raw material)
applications. If applicable to implant performance, documen-
shall have a purity of not less than 98 % for calcium sulfate
tation of typical compressive strength and the methods used to
(absent of water) when measured by USP 24 NF 19. (This
determineitshouldbereportedinordertoinformthefinaluser.
purity measurement method may not be applicable to the
Test Methods C472 as described in Specification C59/C59M
fabricated forms containing substantial quantities of additives.)
canbeusedforthetypicalcomp
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