ASTM F1088-23

Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

ABSTRACT
This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate. The calcium and phosphorus content shall be determined using a suitable method such X-ray fluorescence. A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined using powder diffraction method. The analysis of other trace elements may be required, based on the conditions, apparatus, or environment. It is recommended that all metals or oxides present in concentrations equal or greater than 0.1 % be noted in material descriptions.
SCOPE
1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).  
1.2 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.  
1.3 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: F1088 − 23
Standard Specification for
Medical-Grade Beta-Tricalcium Phosphate Raw Material for
1
Implantable Medical Devices
This standard is issued under the fixed designation F1088; 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 ANSI/ISO/ASQ 9001 Quality Management Systems—
Requirements
1.1 This specification covers chemical and crystallographic
ANSI/ISO 10993-1 Biological Evaluation of Medical
requirements for beta-tricalcium phosphate (β-TCP) raw ma-
Devices—Part 1: Evaluation Within a Risk Management
terials intended for use in medical device applications. For a
System
material to be identified as medical-grade beta-tricalcium
ANSI/ISO/ASQ 13485 Medical Devices—Quality Manage-
phosphate, it must conform to this specification (see Appendix
ment Systems—Requirements for Regulatory Purposes
X1).
4
2.3 United States Pharmacopeia (USP) Documents:
1.2 This standard does not purport to address all of the
USP <191> Identification Tests for Calcium and Phosphate
safety concerns, if any, associated with its use. It is the
USP <232> Elemental Impurities—Limits
responsibility of the user of this standard to establish appro-
USP <233> Elemental Impurities—Procedure
priate safety, health, and environmental practices and deter-
5
2.4 ICH Document:
mine the applicability of regulatory limitations prior to use.
ICH Q3D International Conference on Harmonization of
1.3 This international standard was developed in accor-
Technical Requirements for Registration of Pharmaceuti-
dance with internationally recognized principles on standard-
cals for Human Use: Guideline for Elemental Impurities
ization established in the Decision on Principles for the
6
2.5 U.S. Code of Federal Regulations:
Development of International Standards, Guides and Recom-
21 CFR 820 Food and Drugs Services, Part 820—Quality
mendations issued by the World Trade Organization Technical
System Regulation
Barriers to Trade (TBT) Committee.
3. Chemical Requirements
2. Referenced Documents
3.1 Elemental analysis for calcium and phosphorus will be
2
2.1 ASTM Standards:
consistent with the expected stoichiometry of beta-tricalcium
F748 Practice for Selecting Generic Biological Test Methods
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
for Materials and Devices
shall be determined using a suitable method such as USP
F981 Practice for Assessment of Compatibility of Biomate-
<191> (see 2.3) or X-ray fluorescence.
rials for Surgical Implants with Respect to Effect of
3.2 A quantitative X-ray diffraction analysis shall indicate a
Materials on Muscle and Insertion into Bone
minimum beta-tricalcium phosphate content of 95 % as deter-
2.2 International Organization for Standardization Docu-
7
mined using Powder Diffraction File No. 550898 and a
3
ments:
8 9,10
method equivalent to Forman or Rietveld.
ANSI/ISO/ASQ 9000 Quality Management Systems—
3.3 Elemental Impurities:
Fundamentals and Vocabulary
4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
1
This specification is under the jurisdiction of ASTM Committee F04 on MD 20852-1790, http://www.usp.org.
5
Medical and Surgical Materials and Devices and is the direct responsibility of Available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, P.O. Box 758,
Subcommittee F04.13 on Ceramic Materials. 1211 Geneva 13, Switzerland. Available online at http://www.ich.org/LOB/media/
Current edition approved April 15, 2023. Published April 2023. Originally MEDIA423.pdf.
6
approved in 1987. Last previous edition approved in 2018 as F1088 – 18. DOI: Available from U.S. Government Publishing Office (GPO), 732 N. Capitol St.,
10.1520/F1088-23. NW, Washington, DC 20401, http://www.gpo.gov.
2 7
For referenced ASTM standards, visit the ASTM website, www.astm.org, or International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM PA 19073-3273.
8
Standards volume information, refer to the standard’s Document Summary page on Forman, D. W. and Metsger, D. S., “The Determination of Phase Composition
the ASTM website. of Calcium Phosphate Ceramics by X-Ray Diffraction,” Transactions of the Seventh
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., Annual Meeting of the American Society for Bone and Mineral Research,
4th Floor, New York, NY 10036, http://www.ansi.org. Kelseyville, CA, 1985 p. 391.
Copyrigh
...

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: F1088 − 18 F1088 − 23
Standard Specification for
Medical-Grade Beta-Tricalcium Phosphate for Surgical
1
ImplantationRaw Material for Implantable Medical Devices
This standard is issued under the fixed designation F1088; 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 beta-tricalcium phosphate (β-TCP) for surgical
implant raw materials intended for use in medical device applications. For a material to be identified as medical-grade
beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).
1.2 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.
1.3 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
2
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
3
2.2 American Society for Quality (ASQ) Document:
C1 Specification of General Requirements for a Quality Program
3
2.2 International Organization for Standardization Document:Documents:
ANSI/ISO/ASQ 9000 Quality Management Systems—Fundamentals and Vocabulary
ANSI/ISO/ASQ 9001 Quality Management Systems—Requirements
ISOANSI/ISO 10993-1 Biological Evaluation of Medical Devices — Part Devices—Part 1: Evaluation Within a Risk
Management System
ANSI/ISO/ASQ 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
4
2.3 United States Pharmacopeia (USP) Documents:
USP <191> Identification Tests for Calcium and Phosphate
USP <232> United States Pharmacopeia: Elemental Impurities – LimitsElemental Impurities—Limits
USP <233> United States Pharmacopeia: Elemental Impurities – ProcedureElemental Impurities—Procedure
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 Nov. 15, 2018April 15, 2023. Published January 2019April 2023. Originally approved in 1987. Last previous edition approved in 20102018 as
F1088 – 04aF1088 – 18.(2010). DOI: 10.1520/F1088-18. 10.1520/F1088-23.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1088 − 23
5
2.4 ICH Document:
ICH Q3D International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use: Guideline for Elemental Impurities
6
2.5 U.S. Code of Federal Regulations:
21 CFR 820 Food and Drugs Services, Part 820—Quality System Regulation
3. Chemical Requirements
3.1 Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate
(Ca (PO ) . The calcium and phosphorus content shall be determined using a suitable method such as USP <191> (see 2.42.3) or
3 4 2
X-ray fluorescence.
3.2 A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined
7 8 9,10
using Powder Diffraction File #550898No. 550898 and a method equivalent to Forman or Rietveld.
3.3
...