ASTM F1185-03

Standard Specification for Composition of Hydroxylapatite for Surgical Implants

ABSTRACT
This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography. A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 %. The concentration of trace elements such as arsenic, cadmium, mercury, and lead shall be determined for hydroxylapatite derived from natural resources. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials. Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods mentioned shall be used.
SCOPE
1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.)
1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)² and by laboratory studies (4-6).
1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacutring processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.
1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)

General Information

• Status: Historical
• Publication Date: 09-Apr-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

Relations

• Replaced By: ASTM F1185-03(2009) - Standard Specification for Composition of Hydroxylapatite for Surgical Implants
• Effective Date: 15-Jun-2009
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1926/F1926M-14(2021) - Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1581-08(2020) - Standard Specification for Composition of Anorganic Bone for Surgical Implants
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1609-23 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Apr-2003

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: F 1185 – 03
Standard Specification for
Composition of Hydroxylapatite for Surgical Implants
This standard is issued under the fixed designation F 1185; 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 2.3 National Formulary:
Tribasic Calcium Phosphate
1.1 This specification covers chemical and crystallographic
2.4 United States Pharmacopeia:
requirements for hydroxylapatite intended for surgical im-
Identification Tests for Calcium and Phosphate <191>
plants. For a material to be called hydroxylapatite, it must
Lead < 251>
conform to this specification. (See Appendix X1.)
Mercury <261>
1.2 The biological response to hydroxylapatite in soft tissue
Arsenic <211>
and bone has been characterized by a history of clinical use
2 Heavy Metals <231> Method 1
(1-3) and by laboratory studies (4-6).
2.5 U. S. Geological Survey Method:
1.3 This specification includes powder, particulate, and
Cadmium
forms intended for use as surgical implants, components of
2.6 American Society for Quality:
surgical implants, or as raw materials for manufacturing
C1 Specification of General Requirements for a Quality
processes such as thermal spray coating, electrophoretic depo-
Program
sition, physical vapor deposition, and so forth.
1.4 This specification specifically excludes hydroxylapatite
3. Terminology
coatings, amorphous calcium phosphate, ceramic-glasses,
3.1 Descriptions of Terms Specific to This Standard:
tribasic calcium phosphate, whitlockite, and alpha- and beta-
3.1.1 hydroxylapatite—the chemical substance having the
tricalcium phosphate. (See Specification F 1088.)
empirical formula Ca (PO ) OH.
5 4 3
2. Referenced Documents
4. Chemical Requirements
2.1 ASTM Standards:
4.1 Elemental analysis for calcium and phosphorus will be
F 748 Practice for Selecting Generic Biological Test Meth-
3 consistent with the expected stoichiometry of hydroxylapatite.
ods for Materials and Devices
The calcium and phosphorus contents shall be determined
F 981 Practice for Assessment of Compatibility of Bioma-
using a suitable method such as ion chromatography.
terials for Surgical Implants with Respect to Effect of
3 4.2 Aquantitative X-ray diffraction analysis shall indicate a
Materials on Muscle and Bone
minimum hydroxylapatite content of 95 % as determined in
F 1088 Specification for Beta-Tricalcium Phosphate for
3 accordance with Practice F 2024. Analysis of relative peak
Surgical Implantation
intensities shall be consistent with published data.
F 2024 Practice for X-Ray Diffraction Determination of
Phase Content of Plasma-Sprayed Hydroxyapatite Coat-
National Formulary XVI.Available from U.S. Pharmacopeia Convention, Inc.,
ings
4 12601 Twinbrook Parkway, Rockville, MD 20852.
2.2 Code of Federal Regulations:
United States Pharmacopeia XXI.Available from U.S. Pharmacopeia Conven-
Title 21, Part 820.
tion, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335-340.
1 8
This specification is under the jurisdiction of ASTM Committee F04 on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Medical and Surgical Materials and Devices and is the direct responsibility of Milwaukee, WI 53203.
Subcommittee F04.13 on Ceramic Materials. Chemical Abstracts Service Registry Number [1306-06-5].
Current edition approved Apr. 10, 2003. Published May 2003. Originally The Joint Committee on Powdered Diffraction Standards has established a
e1
approved in 1988. Last previous edition approved in 1993 as F 4485 – 88 (1993) . Powder Diffraction File. The Committee operates on an international basis and
The boldface numbers in parentheses refer to the list of references at the end of cooperates closely with the Data Commission of the International Union of
this specification. Crystallography and ASTM (American Society for Testing and Materials). Hy-
Annual Book of ASTM Standards, Vol 13.01. droxylapatite data can be found on file card number 9-432 and is available from the
Available from U.S. Government Printing Office, N. Capitol and H St., NW, Joint Committee on Powder Diffraction Standards, 1600 Park Lane, Swarthmore,
Washington, DC 20402. PA 19081.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1185–03
4.3 For hydroxylapatite derived from natural sources, the 5. Biocompatibility
concentration of trace elements shall be limited as follows:
5.1 Before any new device is used clinically, the tissue
Element ppm, max
response should be characterized by the methods re
...