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ASTM F2224-09(2020)

(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, 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.

General Information

Status
Published
Publication Date
31-Jul-2020
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

Refers
ASTM C472-20 - Standard Test Methods for Physical Testing of Gypsum, Gypsum Plasters, and Gypsum Concrete
Effective Date
01-Apr-2020

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ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical ImplantsASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
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ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
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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.
Designation: F2224 −09 (Reapproved 2020)
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,
fabricated and fabricated forms of hydrated calcium sulfate
health, and environmental practices and determine the appli-
intended for surgical implants. Fabricated forms may include
cability of regulatory limitations prior to use.
pressed and cast surgical implants in various geometric shapes.
1.8 This international standard was developed in accor-
The calcium sulfate hemihydrate in the unfabricated form can
dance with internationally recognized principles on standard-
be converted with the addition of water or other water-
ization established in the Decision on Principles for the
containing solutions to a fabricated calcium sulfate dihydrate
Development of International Standards, Guides and Recom-
form.
mendations issued by the World Trade Organization Technical
1.2 The requirements of this specification apply to calcium
Barriers to Trade (TBT) Committee.
sulfate combined with two molecules of water or two calcium
sulfate molecules sharing one water molecule.
2. Referenced Documents
Approximate chemical formulae:
3
2.1 ASTM Standards:
Calcium Sulfate Dihydrate
C59/C59M Specification for Gypsum Casting Plaster and
CaSO ·2H O
4 2
Gypsum Molding Plaster
Calcium Sulfate Hemihydrate
C472 Test Methods for Physical Testing of Gypsum, Gyp-
CaSO ·1/2H O or CaSO ·H O·CaSO
4 2 4 2 4
sum Plasters, and Gypsum Concrete
1.3 This specification specifically excludes calcium sulfate
F648 Specification for Ultra-High-Molecular-Weight Poly-
anhydrite and calcium sulfate forms that contain additives such
ethylene Powder and Fabricated Form for Surgical Im-
as reinforcing phases, medicaments, biological agents, and so
plants
forth.
F756 Practice for Assessment of Hemolytic Properties of
Materials
1.4 The presence of processing aids does not exclude a
product from the physical and mechanical requirements of this F763 Practice for Short-Term Screening of Implant Materi-
als
specification.
F813 Practice for Direct Contact Cell Culture Evaluation of
1.5 Some provisions of Specification C59/C59M and Test
Materials for Medical Devices
Methods C472 apply. Special requirements that are detailed in
F895 TestMethodforAgarDiffusionCellCultureScreening
this specification are included to characterize the material
for Cytotoxicity
which will be used in surgical implants.
F981 Practice for Assessment of Compatibility of Biomate-
1.6 Thebiologicalresponsetocalciumsulfateinbonetissue
rials for Surgical Implants with Respect to Effect of
2
has been well characterized by a history of clinical use (1-14)
Materials on Muscle and Insertion into Bone
and by laboratory studies (15-18).
F1088 Specification for Beta-Tricalcium Phosphate for Sur-
1.7 The following precautionary caveat pertains only to the gical Implantation
test method portion, Sections 4, 5, and 6, of this specification. F1635 Test Method for in vitro Degradation Testing of
HydrolyticallyDegradablePolymerResinsandFabricated
1
Forms for Surgical Implants
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 Aug. 1, 2020. Published August 2020. Originally
3
approved in 2003. Last previous edition approved in 2014 as F2224 – 09 (2014). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F2224-09R20. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2224 − 09 (2020)
2.2 Other Documents: 4.2 The total concentration of heavy metals (for example,
BS 6463-102:
...

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A1.1 Significance and Use
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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

  • Guide
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    English language
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  • Guide
    34 pages
    English language
    sale 15% off