ASTM F1581-08e1
(Specification)Standard Specification for Composition of Anorganic Bone for Surgical Implants
Standard Specification for Composition of Anorganic Bone for Surgical Implants
ABSTRACT
This specification covers material requirements for chemical composition of anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and betatricalcium phosphate. Elemental analysis for calcium and phosphorus shall be consistent with the expected composition of the source of the biologically-derived bone mineral. X-ray diffraction analysis of the material shall be consistent with that specified for hydroxyapatite and calcium phosphate carbonate (carbonated apatite). The crystal size of the anorganic bone shall be determined from the X-ray diffraction data using the well-known Scherrer formula. The concentration of trace elements in the anorganic bone shall conform to the prescribed limit for: arsenic, cadmium, mercury, lead, and heavy metals (as lead), which may be determined by the following methods: inductively coupled plasma-mass spectroscopy (ICP-MS) or USP method and graphite furnace atomic absorption spectrophotometry. Organic content shall be measured either as total carbon or nitrogen or total protein by amino acid analyses. The carbonate content of the anorganic bone shall be determined. Functional groups shall be identified by infrared analysis. Requirements for biocompatibility and sterilization are given as well.
SCOPE
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1).
1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3). Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7).
1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).
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Designation:F1581 −08
StandardSpecification for
1
Composition of Anorganic Bone for Surgical Implants
This standard is issued under the fixed designation F1581; 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
´ NOTE—Mercury warning was editorially added in April 2008.
1. Scope safety and health practices and determine the applicability of
regulatory limitations prior to use. (See Appendix X2).
1.1 This specification covers material requirements for an-
organic xenogeneic or allogeneic bone (apatite) intended for
2. Referenced Documents
surgical implants. For a material to be called anorganic or
3
2.1 ASTM Standards:
deorganified bone, it must conform to this specification (see
D513 Test Methods forTotal and Dissolved Carbon Dioxide
Appendix X1).
in Water
1.2 Thebiologicalresponsetoapatiteinsofttissueandbone
D1688 Test Methods for Copper in Water
has been characterized by a history of clinical use and by
D2972 Test Methods for Arsenic in Water
2
laboratory studies (1, 2, 3). Xenogeneic bone, with organic
D3557 Test Methods for Cadmium in Water
components present, has been shown to be antigenic in the
D3559 Test Methods for Lead in Water
human host (4) whereas the same material that has been
D3919 Practice for Measuring Trace Elements in Water by
completely deorganified has been shown to elicit no inflam-
Graphite Furnace Atomic Absorption Spectrophotometry
matory or foreign body reactions in human clinical use (5, 6,
D4129 Test Method for Total and Organic Carbon in Water
7).
by High Temperature Oxidation and by Coulometric
1.3 This specification specifically excludes synthetic
Detection
hydroxylapatite, hydroxylapatite coatings, ceramic glasses,
E1184 Practice for Determination of Elements by Graphite
tribasic calcium phosphate, whitlockite, and alpha- and beta-
Furnace Atomic Absorption Spectrometry
tricalcium phosphate.
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.4 Warning—Mercury has been designated by EPA and
F1185 Specification for Composition of Hydroxylapatite for
many state agencies as a hazardous material that can cause
Surgical Implants
central nervous system, kidney, and liver damage. Mercury, or
4
2.2 Code of Federal Regulations:
its vapor, may be hazardous to health and corrosive to
Title 21, Part 820
materials.Cautionshouldbetakenwhenhandlingmercuryand
5
mercury-containing products. See the applicable product Ma- 2.3 National Formulary:
terial Safety Data Sheet (MSDS) for details and EPA’s website Tribasic Calcium Phosphate
6
(http://www.epa.gov/mercury/faq.htm) for additional informa-
2.4 United States Pharmocopeia:
tion. Users should be aware that selling mercury or mercury-
Identification Tests for Calcium and Phosphate <191>
containingproducts,orboth,inyourstatemaybeprohibitedby
Lead < 251>
state law.
Mercury <261>
1.5 This standard does not purport to address all of the
safety concerns, such as health concerns due to the presence of
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
transmissible disease, associated with its use. It is the respon-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
sibility of the user of this standard to establish appropriate Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
4
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
1
This specification is under the jurisdiction of ASTM Committee F04 on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
Medical and Surgical Materials and Devices and is under the direct responsibility of www.access.gpo.gov.
5
Subcommittee F04.13 Ceramic Materials. National Formulary 25. Available from U.S. Pharmacopeia (USP), 12601
Current edition approved Feb. 1, 2008. Published March 2008. Originally Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org. Succeeding
approved in 1995. Last previous edition approved in 1999 as F1581 – 99. DOI: USP editions may alternatively be referenced.
6
10.1520/F1581-08E01. United States Pharmacopeia 30. Available from U.S. Pharmacopeia (USP),
2
The boldface numbers in parentheses refer to the list of references at the end of 12601TwinbrookPkwy.,Rockville,MD20852-1790,http://www.usp.org.Succeed-
this specification. ing USP editions may alternatively be referenced.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1581−08
Cadmium <461> atomic absorption spectrophotometry may also be used for
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
e1
Designation:F1581–99 Designation: F 1581 – 08
Standard Specification for
1
Composition of Anorganic Bone for Surgical Implants
This standard is issued under the fixed designation F 1581; 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
e NOTE—Mercury warning was editorially added in April 2008.
1. Scope
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical
implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1).
1.2 Thebiologicalresponsetoapatiteinsofttissueandbonehasbeencharacterizedbyahistoryofclinicaluseandbylaboratory
2
studies(1,2,3). Xenogeneicbone,withorganiccomponentspresent,hasbeenshowntobeantigenicinthehumanhost(4)whereas
the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in
human clinical use (5, 6, 7). ).
1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic
calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.
1.4This standard does not pruport to address all of the safety concerns, such as health concerns due to the presence of
transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory limitations prior to use.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware
that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of
transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).
2. Referenced Documents
3
2.1 ASTM Standards:
D 513 Test Methods for Total and Dissolved Carbon Dioxide in Water
D 1688 Test Methods for Copper in Water
D 2972 Test Methods for Arsenic in Water
D 3557 Test Methods for Cadmium in Water
D 3559 Test Methods for Lead in Water
3
D 3919Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D4129Test Method for Total and Organic Carbon in Water High Temperature Oxidation and Coulometric Detection Practice
for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D 4129 Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection
E 1184 Practice for Electrothermal (Graphite Furnace) Atomic Absorption Analysis
F748Practice For Selecting Generic Biological Test Methods for Materials and Devices
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 1185 Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibilityof
Subcommittee F04.13 Ceramic Materials.
Current edition approved Feb. 10, 1999.1, 2008. Published June 1999.March 2008. Originally published as F1581–95.approved in 1995. Last previous edition approved
in 1999 as F 1581 – 969.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol. 11.01. volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box
...
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