ASTM F1088-18

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

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) for surgical implant 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 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: Historical
• Publication Date: 14-Nov-2018
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F1088 − 18
Standard Specification for
1
Beta-Tricalcium Phosphate for Surgical Implantation
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 USP <232> United States Pharmacopeia: Elemental Impuri-
ties – Limits
1.1 This specification covers chemical and crystallographic
USP <233> United States Pharmacopeia: Elemental Impuri-
requirements for beta-tricalcium phosphate (β-TCP) for surgi-
ties – Procedure
cal implant applications. For a material to be identified as
6
2.5 ICH Document:
medical-grade beta-tricalcium phosphate, it must conform to
ICH Q3D International Conference on Harmonization of
this specification (see Appendix X1).
Technical Requirements for Registration of Pharmaceuti-
1.2 This international standard was developed in accor-
cals for Human Use: Guideline for Elemental Impurities
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
3. Chemical Requirements
Development of International Standards, Guides and Recom-
3.1 Elemental analysis for calcium and phosphorus will be
mendations issued by the World Trade Organization Technical
consistent with the expected stoichiometry of beta-tricalcium
Barriers to Trade (TBT) Committee.
phosphate (Ca (PO ) . The calcium and phosphorus content
3 4 2
2. Referenced Documents shall be determined using a suitable method such as USP
2 <191> (see 2.4) or X-ray fluorescence.
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods 3.2 A quantitative X-ray diffraction analysis shall indicate a
minimum beta-tricalcium phosphate content of 95 % as deter-
for Materials and Devices
7
F981 Practice for Assessment of Compatibility of Biomate- mined using Powder Diffraction File #550898 and a method
8 9,10
rials for Surgical Implants with Respect to Effect of equivalent to Forman or Rietveld.
Materials on Muscle and Insertion into Bone
3.3 Elemental Impurities:
3
2.2 American Society for Quality (ASQ) Document:
3.3.1 The significance of elemental impurities within an
C1 Specification of General Requirements for a Quality
absorbable material is ultimately dependent on the dimensional
Program
characteristics of the final product and the rate of release of
2.3 International Organization for Standardization Docu-
those initially interstitial elements into the surrounding tissue
4
ment:
and extracelluar fluid. Thus, any risk assessment of such
ISO 10993-1 Biological Evaluation of Medical Devices —
impurities will be dependent on the final product design and
Part 1: Evaluation Within a Risk Management System
intended application. Consequently, this raw material (not final
5
2.4 United States Pharmacopeia (USP) Documents:
device) standard provides for appropriate reporting of elemen-
USP <191> Identification Tests for Calcium and Phosphate
tal impurities values, but does not mandate any specific
performance requirements. More detailed and pharmaceutical-
oriented guidance regarding the appropriate means for both
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials.
6
Current edition approved Nov. 15, 2018. Published January 2019. Originally Available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, P.O. Box 758,
approved in 1987. Last previous edition approved in 2010 as F1088 – 04a(2010). 1211 Geneva 13, Switzerland. Available online at http://www.ich.org/LOB/media/
DOI: 10.1520/F1088-18. MEDIA423.pdf.
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 Society for Quality (ASQ), 600 N. Plankinton Ave., Annual Meeting of the American Society for Bone and Mineral Research,
Milwaukee, WI 53203, http://www.asq.org. Kelseyville, CA, 1985 p. 391.
4 9
Available from American National Standards Institute (ANSI), 25 W. 43rd St., Jackson, L. E., Barralet, J. E., and Wright, A. J., “Rietveld Analysis in Sintering
4th Floor, New York, NY 10036, http://www.ansi.org. Studies of Ca-Deficient Hydrxyapatite,”Bioceramic
...

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 − 04a (Reapproved 2010) F1088 − 18
Standard Specification for
1
Beta-Tricalcium Phosphate for Surgical Implantation
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 biocompatible beta-tricalcium phosphate (β-TCP)
for surgical implant applications. For a material to be identified as medical grade medical-grade beta-tricalcium phosphate, it must
conform to this specification (see Appendix X1).
1.2 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
4
2.3 International Organization for Standardization Document:
ISO 1099310993-1 Biological Evaluation of Medical Devices — Part 1: Evaluation Within a Risk Management System
5
2.4 United States Pharmacopeia (USP) Documents:
Identification Tests for Calcium and Phosphate USP <191> Identification Tests for Calcium and Phosphate
Lead <252>USP <232> United States Pharmacopeia: Elemental Impurities – Limits
Mercury <261>USP <233> United States Pharmacopeia: Elemental Impurities – Procedure
Arsenic <211>
Heavy Metals <231> Method 1
6
2.5 Other Reference:ICH Document:
U.S. Geological Survey MethodICH Q3D International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use: Guideline for Elemental Impurities
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
3 4 2
2.4) or X-ray fluorescence.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Sept. 1, 2010Nov. 15, 2018. Published November 2010 January 2019. Originally approved in 1987. Last previous edition approved in 20042010
ε1
as F1088 – 04a .(2010). DOI: 10.1520/F1088-04AR10.10.1520/F1088-18.
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 Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
6
Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in National Bureaus of Standards Geological Reference Materials SRM 278 Obsidian and
SRM 688 Basalt by Inductively Coupled Plasma—Atomic Emission Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.Available from ICH Secretariat, c/o
IFPMA, 30 rue de St-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland. Available online at http://www.ich.org/LOB/media/MEDIA423.pdf.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1088 − 18
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 #550898 and a method equivalent to Forman or Rietveld.
3.3 For beta-tricalcium phosphate, the concentration of trace elements s
...