ASTM F1926/F1926M-14

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

SIGNIFICANCE AND USE
4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use (1-11).3  
4.2 The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F1185), beta-tricalcium phosphate (see Specification F1088), and biphasic mixtures thereof with or without intentional addition of other minor components (  
4.3 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No correlation of the results to in vivo performance is implied. Therefore, it is recommended that a control material be included in the evaluation. The control material can be a standardized material such as NIST SRM 2910 or a historical control.
SCOPE
1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications.  
1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions.  
1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product.  
1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.6 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 limitations prior to use.

General Information

• Status: Historical
• Publication Date: 14-May-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

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: F1926/F1926M − 14
Standard Test Method for
Dissolution Testing of Calcium Phosphate Granules,
1
Fabricated Forms, and Coatings
ThisstandardisissuedunderthefixeddesignationF1926/F1926M;thenumberimmediatelyfollowingthedesignationindicatestheyear
of original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.
A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F1185Specification for Composition of Hydroxylapatite for
Surgical Implants
1.1 This test method covers calcium phosphate materials
intended for use in surgical implant applications.
3. Terminology
1.2 The material(s) shall be representative of that produced
3.1 Definitions of Terms Specific to This Standard:
for sale. It shall have been produced and processed under
3.1.1 calcium phosphate, n—any one of a number of inor-
standard manufacturing conditions.
ganic chemical compounds containing calcium and phosphate
1.3 The materials may be in the form of powders, granules,
ions as its principal constituents.
spall material, fabricated forms or coatings; and may be
3.1.2 coating, n—layer of material mechanically or chemi-
porous,nonporous,textured,andotherimplantabletopographi-
cally adhering to the surface of a substrate.
cal substrate form representative of the end-use product.
1.4 The calcium phosphate material may constitute the only
4. Significance and Use
materialinasubstrateoritmaybeoneofmultiplematerialsso
4.1 Aspectsofthebiologicalresponsetocalciumphosphate
longasallothermaterialspresentdonotdissolveunderthetest
materials in soft tissue and bone have been reported from
conditions described in this test method.
3
laboratory studies and clinical use (1-11).
1.5 The values stated in either SI units or inch-pound units
4.2 The requirements of this test method apply to calcium
are to be regarded separately as standard. The values stated in
phosphate materials such as calcium hydroxyapatite (see
each system may not be exact equivalents; therefore, each
Specification F1185), beta-tricalcium phosphate (see Specifi-
system shall be used independently of the other. Combining
cation F1088), and biphasic mixtures thereof with or without
values from the two systems may result in nonconformance
intentional addition of other minor components (<10 %).
with the standard.
1.6 This standard does not purport to address all of the 4.3 This test method is limited to the laboratory evaluation
of the dissolution rate of a calcium phosphate material. No
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- correlation of the results to in vivo performance is implied.
Therefore, it is recommended that a control material be
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. included in the evaluation. The control material can be a
standardized material such as NIST SRM 2910 or a historical
2. Referenced Documents
control.
2
2.1 ASTM Standards:
E691Practice for Conducting an Interlaboratory Study to
5. Dissolution Media
Determine the Precision of a Test Method
5.1 Water used for preparing reagents or dissolution media
F1088Specification for Beta-Tricalcium Phosphate for Sur-
shall be degassed carbon dioxide free deionized or distilled
gical Implantation
++
water and have less than 0.1 ppm of residual Ca ion.
Optionally, the water can be degassed in situ.
1
This test method is under the jurisdiction ofASTM Committee F04 onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
5.2 Unbuffered Water Media—Deionized or distilled water
F04.13 on Ceramic Materials. –5 –5 –5
containing8×10 M NaCl,8×10 M CaCl,and5×10
2
Current edition approved May 15, 2014. Published July 2014. Originally
MK (PO ).
published in 1998. Last previous edition approved in 2010 as F1926/F1926M–10. 3 4
DOI: 10.1520/F1926_F1926M-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
the ASTM website. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1926/F1926M − 14
5.3 pH 5.5 MES Buffer Media—1.0 M MES, [2-(N- electrode manufacturer. Other methods (for example,
morphplino)ethanesulfonic acid] having a pH of 5.5 at 37 6 colorimetrically, atomic absorption (AA), inductively coupled
–5 –5
0.5°Candcontaining8×10 MNaCl,8×10 MCaCl ,and plasma (ICP) spectroscopy, or inductively coupled plasma
2
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F1926/F1926M − 10 F1926/F1926M − 14
Standard Test Method for
Evaluation of the Environmental Stability of Dissolution
Testing of Calcium Phosphate Granules, Fabricated Forms,
1
and Coatings
This standard is issued under the fixed designation F1926/F1926M; 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 test method covers calcium phosphate materials intended for use in surgical implant applications.
1.2 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory
2
studies and clinical use (1-10).
1.3 The requirements of this specification apply to calcium phosphate materials such as calcium hydroxyapatite (see
Specification F1185), beta-tricalcium phosphate (see Specification F1088), and biphasic mixtures thereof with or without
intentional addition of other minor components (<10 %).
1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard
manufacturing conditions.
1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous,
nonporous, textured, and other implantable topographical substrate form representative of the end-use product.
1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so
long as all other materials present do not dissolve under the test conditions described in this test method.
1.7 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No
correlation of the results to in vivo performance is implied.
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformancenonconformance with the standard.
1.6 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
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 calcium phosphate—phosphate, n—any one of a number of inorganic chemical compounds containing calcium and
phosphate ions as its principal constituents.
1
This test method is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.13
on Ceramic Materials.
Current edition approved Dec. 1, 2010May 15, 2014. Published December 2010July 2014. Originally published in 1998. Last previous edition approved in 20082010 as
F1926/F1926M – 08.F1926/F1926M – 10. DOI: 10.1520/F1926_F1926M-10. 10.1520/F1926_F1926M-14.
2
The boldface numbers given in parentheses refer to a list of references at the end of the text.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
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

---------------------- Page: 1 ----------------------
F1926/F1926M − 14
3.1.2 coating—coating, n—a layer of material mechanically or chemically adhering to the surface of a substrate.
4. Significance and Use
4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory
3
studies and clinical use (1-11).
4.2 The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification
F1185), beta-tricalcium phosphate (see Specification F1088), and bip
...