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ASTM F2224-03

(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 DihydrateCaSO42H2OCalcium Sulfate HemihydrateCaSO41/2H2O or CaSO4H2OCaSO4
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./p>

General Information

Status
Historical
Publication Date
09-Jan-2003
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

Replaced By
ASTM F2224-09 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Effective Date
01-Sep-2009

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ASTM F2224-03 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical ImplantsASTM F2224-03 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
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ASTM F2224-03 - 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: F 2224 – 03
Standard Specification for
High Purity Calcium Sulfate Hemihydrate or Dihydrate for
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and
1.1 This specification covers material requirements for un-
health practices and determine the applicability of regulatory
fabricated and fabricated forms of hydrated calcium sulfate
requirements prior to use.
intended for surgical implants. Fabricated forms may include
pressed and cast surgical implants in various geometric shapes.
2. Referenced Documents
The calcium sulfate hemihydrate in the unfabricated form can
2.1 ASTM Standards:
be converted with the addition of water or other water-
C 59/C 59M Specification for Gypsum Casting Plaster and
containing solutions to a fabricated calcium sulfate dihydrate
Gypsum Molding Plaster
form.
C 472 Test Methods for Physical Testing of Gypsum, Gyp-
1.2 The requirements of this specification apply to calcium
sum Plasters and Gypsum Concrete
sulfate combined with two molecules of water or two calcium
F 648 Specification for Ultra-High-Molecular-Weight Poly-
sulfate molecules sharing one water molecule.
ethylene Powder and Fabricated Form for Surgical Im-
Approximate chemical formulae:
plants
Calcium Sulfate Dihydrate
F 756 Practice for Assessment of Hemolytic Properties of
CaSO ·2H O
4 2
Materials
Calcium Sulfate Hemihydrate
F 763 Practice for Short-Term Screening of Implant Mate-
CaSO ·1/2H O or CaSO ·H O·CaSO
4 2 4 2 4
rials
1.3 This specification specifically excludes calcium sulfate
F 813 PracticeforDirectContactCellCultureEvaluationof
anhydrite and calcium sulfate forms that contain additives such
Materials for Medical Devices
as reinforcing phases, medicaments, biological agents, and so
F 895 Test Method forAgar Diffusion Cell Culture Screen-
forth.
ing for Cytotoxicity
1.4 The presence of processing aids does not exclude a
F 981 Practice for Assessment of Compatibility of Bioma-
product from the physical and mechanical requirements of this
terials for Surgical Implants with Respect to Effect of
specification.
Materials on Muscle and Bone
1.5 Some provisions of Specification C 59/C 59M and Test
F 1088 Specification for Beta-Tricalcium Phosphate for
Methods C 472 apply. Special requirements that are detailed in
Surgical Implantation
this specification are included to characterize the material
F 1635 Test Method for In Vitro Degradation Testing of
which will be used in surgical implants.
Poly(L-lactic acid) Resin and Fabricated Form for Surgical
1.6 Thebiologicalresponsetocalciumsulfateinbonetissue 4
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 standard does not purport to address all of the safety
US Pharmacopeia XXIV (USP 24) NF-19
1 3
This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 04.01.
Medical and Surgical Materials and Devicesand is the direct responsibility of Annual Book of ASTM Standards, Vol 13.01.
Subcommittee F04.13on Ceramic Materials. Available from the British Standards Institution, c/o IHS Engineering/IHS
Current edition approved Jan. 10, 2003. Published February 2003. International, 15 Inverness Way East, Englewood, CO 80112.
2 6
The boldface numbers in parentheses refer to the list of references at the end of Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
this standard. MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2224–03
CFR Title 21, Part 820 Quality System Requirements measuring these trace elements are described in Specification
Food Chemical Codex (FCC) F 1088 (Coupled Plasma—Atomic Absorption Spectrometry),
European Pharmacopeia the United States Pharmacopeia (USP), European Pharma-
ISO 10993-1 Biological Evaluation of Medical Devices copeia, or Food Chemical Codex (FCC).Asecond method that
may be used to analyze acid insoluble impurities is described
3. Terminology
in BS 6463-102.
3.1 Definitions:
5. Physical and Mechanical Characterization
3.1.1 calcium sulfate anhydrite—a chemical substance hav-
ing approximate molecular formula of CaSO . 5.1 The following physical and mechanical characterization
3.1.2 calcium sulfate dihydrate—a chemical having the
may be applicable to calcium sulfate for surgical implant
approximate molecular formula of CaSO ·2H O. This sub- applications in either the fabricated form or intra-operative
4 2
stance is also known as gypsum.
fabricated form.When characterization test results are reported
3.1.3 calcium sulfate hemihydrate—a chemical substance in labeling, the test methods associated with these results shall
having approximate molecular formula of CaSO ·1/2HOor
be referenced. Labeling can be defined as but is not limited to
4 2
CaSO ·H O·CaSO . The mineral name of this substance is
the product label, brochures, technical monographs, and other
4 2 4
bassanite and the substance is also known as Plaster of Paris in
related documentation.
the clinical literature.
5.2 Set Time—If set time is an applicable property, it should
3.1.4 processing aids—any constituent intentionally used in
be reported along with the method by which it was determined
the processing of the raw material to fulfill a certain techno-
in order to inform the final user. The set time is defined as the
logical purpose during treatment or processing, which may
typical time for the development of an implantable surgical
resultintheunintentionalbuttechnicallyunavoidablepresence
implant. Test Methods C 472 as described in Specification
of residues of the substance or its derivatives in the final
C 59/C 59Mcanbeusedtodefineatypicalsettime.Theactual
product (<5 % by weight), provided that these residues do not
method used for set time determination shall be described or
present any health risk. Some examples would be: binders, referenced in labeling.
lubricants, compaction aids, disintegrants, plasticizers, defloc-
5.3 Compressive Strength—Calcium sulfate dihydrate in a
culants, wetting agents, water retention agents, antistatic fabricated final form is intended to be used in non-load bearing
agents, antifoam agents, foam stabilizers, chelating or seques-
applications. If applicable to implant performance, documen-
tering agents, phase stabilizers, and so forth. tation of typical compressive strength and the methods used to
determineitshouldbereportedinordertoinformthefinaluser.
4. Chemical Requirements
Test Methods C 472 as described in Specification C 59/C 59M
4.1 Calcium sulfate for surgical implants (raw material)
canbeusedforthetypicalcompressionstrengthdetermination.
shall have a purity of not less than 98 % for calcium sulfate
The actual method
...

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