ASTM F1088-87(1992)e1

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

SCOPE
1.1 The specification defines the chemical and crystallographic properties of beta-tricalcium phosphate intended for surgical implantation. It also informs the user that manufacturers and distributors are obligated to meet certain federal requirements.
1.2 It has been found that material meeting this specification engenders an acceptable biocompatible response as defined in Practice F981 (1).  Other properties of calcium phosphates such as grain size, density, strength, and resorption rates are dependent upon certain process parameters (2-9).
1.3 This specification excludes tribasic calcium phosphate, whitlockite, alpha-tricalcium phosphate, and hydro-xyapatite.

General Information

• Status: Historical
• Publication Date: 31-Dec-1991
• 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

• Replaced By: ASTM F1088-04 - Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• Effective Date: 01-Jan-2004
• Referred By: ASTM F1185-23 - Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
• Effective Date: 01-Jan-1992
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Jan-1992
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Jan-1992
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 01-Jan-1992
• Referred By: ASTM F1926/F1926M-14(2021) - Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• Effective Date: 01-Jan-1992
• Referred By: ASTM F1609-23 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
• Effective Date: 01-Jan-1992

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 1088 – 87 (Reapproved 1992)
Standard Specification for
Beta-Tricalcium Phosphate for Surgical Implantation
This standard is issued under the fixed designation F 1088; 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.
e NOTE—Section 7 was added editorially in December 1992.
1. Scope 3. Chemical Composition
1.1 The specification defines the chemical and crystallo- 3.1 Elemental analyses of calcium and phosphorus will be
graphic properties of beta-tricalcium phosphate intended for consistent with the expected stoichiometry of tricalcium phos-
surgical implantation. It also informs the user that manufactur- phate.
ers and distributors are obligated to meet certain federal
NOTE 2—The precision of wet chemical methods for calcium and
requirements.
phosphorus are not sufficient to easily establish a 95 % purity of tricalcium
1.2 It has been found that material meeting this specification
phosphate. The theoretical calcium and phosphorus content of tricalcium
engenders an acceptable biocompatible response as defined in
phosphate is 38.76 and 19.97 %, respectively. The addition of 5 weight %
hydroxyapatite results in calcium and phosphorous values of 38.82 and
Practice F 981 (1). Other properties of calcium phosphates
19.90, respectively. To identify 5 weight % hydroxyapatite in tricalcium
such as grain size, density, strength, and resorption rates are
phosphate a maximum standard deviation for the calcium method must be
dependent upon certain process parameters (2-9).
0.03; for phosphorus, 0.04 (n = 10, alpha = 0.05, power (1-beta) = 0.90).
1.3 This specification excludes tribasic calcium phosphate,
Precision of this order of magnitude is not expected.
whitlockite, alpha-tricalcium phosphate, and hydroxyapatite.
3.2 Trace Metals:
2. Referenced Documents 3.2.1 The maximum allowable limits of individual heavy
metals are as shown:
2.1 ASTM Standards:
Metal ppm, max
C 674 Test Methods for Flexural Properties of Ceramic
Lead 30
Whiteware Materials
Mercury 5
F 981 Practice for Assessment of Compatibility of Bioma-
Arsenic 3
Cadmium 5
terials (Non-porous) for Surgical Implants with Respect to
Effect of Materials on Muscle and Bone
For referee purposes, Limit Tests 251, 261, 211, (10) and Ref
(11) will be used.
NOTE 1—Test Methods C 674 is referenced only to guide the future
writers or users of performance standards that may yet be deemed
NOTE 3—These maximum values are based upon historical levels found
necessary to promulgate. Test Methods C 674 does not contain any
in commercial calcium phosphates manufactured in the United States
material specifications for beta-tricalcium phosphate.
intended for surgical implantation.
2.2 United States Code of Federal Regulations:
3.2.2 The maximum allowable limit of all heavy metals
Title 21 Part 820 Good Manufacturing Practices for Medical
determined as lead will be 50 ppm as described in Heavy
Devices
Metals (231) Method 1 (10) or equivalent. Sample preparation
will be identical to that for tribasic calcium phosphate as
specified in the National Formulary Official Monograph on
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
Tribasic Calcium Phosphate (12) except that approximately 1 g
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
of material will be dissolved in approximately 30 mL of 5 %
Current edition approved Oct. 30, 1987. Published December 1987.
hydrochloric acid and boiled.
The boldface numbers in parentheses refer to the list of references at the end of
3.2.3 It is recommended that all metals or oxides not
this specification.
detected as lead present in concentrations equal to or greater
Annual Book of ASTM Standards, Vol 15.02.
Annual Book of ASTM Standards, Vol 13.01.
than 0.10 % be listed on the package insert.
Available from U.S. Government Printing Office, North Capital and H Streets
NW, Washington, DC 20401.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1088
4. Crystal Structure 6. Government Regulations
4.1 X-ray diffraction will confirm the beta phase of trical- 6.1 Material intended for commercial distribution will meet
cium phosphate and establish a minimum phase purity of 95 % all applicable requirements imposed by the country of origin. If
according to a method equivalent to those cited in Refs (13 and the material is manufactured for sale or imported within the
14). United States or its territories the manufacturer and its autho-
rized distributors will conform to the good manufacturing
5. Test Specimens
practices as described in Title 21 CFR 820.
5.1 Test specimens from each production run will be in-
7. Keywords
spected according to Title 21 CFR 820.160 and will be shown
to meet the standards of this ASTM specification by an 7.1 bioceramic; bone graft; hydr
...