ASTM F1581-08
(Specification)Standard Specification for Composition of Anorganic Bone for Surgical Implants
Standard Specification for Composition of Anorganic Bone for Surgical Implants
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 This 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. (See Appendix X2).
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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. Scope Graphite Furnace Atomic Absorption Spectrophotometry
D 4129 Test Method forTotal and Organic Carbon inWater
1.1 This specification covers material requirements for an-
by High Temperature Oxidation and by Coulometric De-
organic xenogeneic or allogeneic bone (apatite) intended for
tection
surgical implants. For a material to be called anorganic or
E 1184 Practice for Electrothermal (Graphite Furnace)
deorganified bone, it must conform to this specification (see
Atomic Absorption Analysis
Appendix X1).
F 748 Practice for Selecting Generic Biological Test Meth-
1.2 Thebiologicalresponsetoapatiteinsofttissueandbone
ods for Materials and Devices
has been characterized by a history of clinical use and by
2
F 1185 Specification for Composition of Hydroxylapatite
laboratory studies (1, 2, 3). Xenogeneic bone, with organic
for Surgical Implants
components present, has been shown to be antigenic in the
4
2.2 Code of Federal Regulations:
human host (4) whereas the same material that has been
Title 21, Part 820
completely deorganified has been shown to elicit no inflam-
5
2.3 National Formulary:
matory or foreign body reactions in human clinical use (5, 6,
Tribasic Calcium Phosphate
7).
6
2.4 United States Pharmocopeia:
1.3 This specification specifically excludes synthetic hy-
Identification Tests for Calcium and Phosphate <191>
droxylapatite, hydroxylapatite coatings, ceramic glasses, triba-
Lead < 251>
sic calcium phosphate, whitlockite, and alpha- and beta-
Mercury <261>
tricalcium phosphate.
Cadmium <461>
1.4 This standard does not pruport to address all of the
Arsenic <211>
safety concerns, such as health concerns due to the presence of
Heavy Metals <231> Method 1
transmissible disease, associated with its use. It is the respon-
Nitrogen Determination <4617>
sibility of the user of this standard to establish appropriate
7
2.5 U.S. Geological Survey Method:
safety and health practices and determine the applicability of
Cadmium
regulatory limitations prior to use. (See Appendix X2).
3. Terminology
2. Referenced Documents
3
3.1 Definitions:
2.1 ASTM Standards:
3.1.1 allogeneic, adj—derived from different individuals of
D 513 Test Methods for Total and Dissolved Carbon Diox-
the same species.
ide in Water
3.1.2 anorganic, adj—denoting tissue (for example, bone)
D 1688 Test Methods for Copper in Water
from which the organic material has been totally removed.
D 2972 Test Methods for Arsenic in Water
Also referred to as deorganified, deproteinized or deprotein-
D 3557 Test Methods for Cadmium in Water
ated.
D 3559 Test Methods for Lead in Water
D 3919 Practice for Measuring Trace Elements in Water by
4
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
1
This specification is under the jurisdiction of ASTM Committee F04 on www.access.gpo.gov.
5
Medical and Surgical Materials and Devices and is under the direct responsibility of National Formulary 25. Available from U.S. Pharmacopeia (USP), 12601
Subcommittee F04.13 Ceramic Materials. Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org. Succeeding
Current edition approved Feb. 1, 2008. Published March 2008. Originally USP editions may alternatively be referenced.
6
approved in 1995. Last previous edition approved in 1999 as F 1581 – 99. 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.
3 7
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
Standards volume information, refer to the standard’s Document Summary page on and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
the ASTM website. Spectrometry,” Geostandards Newsletter , Vol 7, 1983, pp. 335–340.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F1581–08
3.1.3 apatite, n—th
...
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.
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. 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.
1.4 This 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. (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
4
2.2 Code of Federal Regulations:
Title 21, Part 820
2.3 National Formulary:
Tribasic Calcium Phosphate
5
2.4
Tribasic Calcium Phosphate
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.
4
Annual Book of ASTM Standards, Vol. 11.02.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
5
Annual Book of ASTM Standards, Vol. 03.06.
5
National Formulary 25.Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org. Succeeding USP editions
may alternatively be referenced.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F1581–08
6
2.4 United States Pharmocopeia:
Identification Tests for Calcium and Phosphate <191>
Lead < 251>
Mercury <261>
Cadmium <461>
Arnsenic <211>
Arsenic <211>
Heavy Metals <231> Method 1
Nitrogen Determination <4617>
2.5 U.S. Geological Survey Method:
7
Cadmium
Cadmium
3. Terminology
3.1 Definitions:
3.1.1 al
...
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