ASTM F1185-23

Standard Specification for Composition of Medical-Grade 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 medical-grade 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 manufacturing 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 F1088).  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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: 14-Apr-2023
• 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)

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: F1185 − 23
Standard Specification for
Composition of Medical-Grade Hydroxylapatite for Surgical
1
Implants
This standard is issued under the fixed designation F1185; 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 2. Referenced Documents
3
2.1 ASTM Standards:
1.1 This specification covers chemical and crystallographic
requirements for hydroxylapatite intended for surgical im- F748 Practice for Selecting Generic Biological Test Methods
for Materials and Devices
plants. For a material to be called medical-grade
hydroxylapatite, it must conform to this specification. (See F981 Practice for Assessment of Compatibility of Biomate-
Appendix X1.) rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Insertion into Bone
1.2 The biological response to hydroxylapatite in soft tissue
F1088 Specification for Medical-Grade Beta-Tricalcium
and bone has been characterized by a history of clinical use
2 Phosphate Raw Material for Implantable Medical Devices
(1-3) and by laboratory studies (4-6).
F2024 Practice for X-ray Diffraction Determination of Phase
1.3 This specification includes powder, particulate, and
Content of Plasma-Sprayed Hydroxyapatite Coatings
forms intended for use as surgical implants, components of
4
2.2 Code of Federal Regulations:
surgical implants, or as raw materials for manufacturing
Title 21 Part 820 Quality System Regulation
processes such as thermal spray coating, electrophoretic
5
2.3 National Formulary:
deposition, physical vapor deposition, and so forth.
Tribasic Calcium Phosphate
1.4 This specification specifically excludes hydroxylapatite
6
2.4 United States Pharmacopeia (USP) Documents:
coatings, amorphous calcium phosphate, ceramic-glasses,
USP <191> Identification Tests for Calcium and Phosphate
tribasic calcium phosphate, whitlockite, and alpha- and beta-
USP <232> Elemental Impurities—Limits
tricalcium phosphate (see Specification F1088).
USP <233> Elemental Impurities—Procedure
1.5 The values stated in SI units are to be regarded as
7
2.5 U.S. Geological Survey Method:
standard. No other units of measurement are included in this
Cadmium
standard.
8
2.6 ANSI/ISO Standards:
1.6 This standard does not purport to address all of the
ANSI/ISO/ASQ 9000 Quality Management Systems—
safety concerns, if any, associated with its use. It is the
Fundamentals and Vocabulary
responsibility of the user of this standard to establish appro-
ANSI/ISO/ASQ 9001 Quality Management Systems—
priate safety, health, and environmental practices and deter-
Requirements
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3
ization established in the Decision on Principles for the
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Development of International Standards, Guides and Recom-
Standards volume information, refer to the standard’s Document Summary page on
mendations issued by the World Trade Organization Technical
the ASTM website.
Barriers to Trade (TBT) Committee.
4
Available from U.S. Government Printing Office, N. Capitol and H St., NW,
Washington, DC 20402.
5
National Formulary XVI. Available from U.S. Pharmacopeia Convention, Inc.,
12601 Twinbrook Parkway, Rockville, MD 20852.
1 6
This specification is under the jurisdiction of ASTM Committee F04 on United States Pharmacopeia XXI. Available from U.S. Pharmacopeia
Medical and Surgical Materials and Devices and is the direct responsibility of Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
7
Subcommittee F04.13 on Ceramic Materials. Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
Current edition approved April 15, 2023. Published April 2023. Originally National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
approved in 1988. Last previous edition approved in 2014 as F1185 – 03 (2014). and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
DOI: 10.1520/F1185-23. Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.
2 8
The boldface numbers in parentheses refer to the list of references at the end of Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
this specification. 4th Floor, New York, NY 10036, http://www.ansi
...

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: F1185 − 03 (Reapproved 2014) F1185 − 23
Standard Specification for
Composition of Medical-Grade Hydroxylapatite for Surgical
1
Implants
This standard is issued under the fixed designation F1185; 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 specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For
a material to be called medical-grade hydroxylapatite, it must conform to this specification. (See Appendix X1.)
2
1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)
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 manufacturing 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. (Seephosphate (see Specification F1088.)).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
3
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1088 Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
1
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 March 1, 2014April 15, 2023. Published March 2014April 2023. Originally approved in 1988. Last previous edition approved in 20092014 as
F1185F1185 – 03 (2014). – 03 (2009). DOI: 10.1520/F1185-03R14.DOI: 10.1520/F1185-23.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
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

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F1185 − 23
F2024 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
4
2.2 Code of Federal Regulations:
Title 21,21 Part 820 Part 820.Quality System Regulation
5
2.3 National Formulary:
Tribasic Calcium Phosphate
6
2.4 United States Pharmacopeia:Pharmacopeia (USP) Documents:
Identification Tests for Calcium and Phosphate USP <191> Identification Tests for Calcium and Phosphate
Lead < 251>USP <232> Elemental Impurities—Limits
Mercury <261>USP <233> Elemental Impurities—Procedure
Arsenic <211>
Heavy Metals <231> Method 1
7
2.5 U. S. U.S. Geological Survey Method:
Cadmium
8
2.6 American Society for Quality:ANSI/ISO Standards:
ANSI/ISO/ASQ 9000 Quality Management Systems—Fundamentals and Vocabulary
ANSI/ISO/ASQ 9001 Quality Management Systems—Requirements
C1ANSI/ISO 10993-1 Specification of General Requirements for a Quality ProgramBiological Evaluation of Medical
Devices—Part 1: Evaluation Within a Risk Management System
ANSI/IS
...