ASTM F1581

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.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

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 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).

2. Referenced Documents

ASTM Standards
D1688 Test Methods for Copper in Water
D2972 Test Methods for Arsenic in Water
D3557 Test Methods for Cadmium in Water
D3559 Test Methods for Lead in Water
D3919 Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D4129 Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection
D513 Test Methods for Total and Dissolved Carbon Dioxide in Water
E1184 Practice for Electrothermal (Graphite Furnace) Atomic Absorption Analysis
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
Code of Federal Regulations
Title21, Part 820
National Formulary
TribasicCalciumPhosphate
United States Pharmocopeia
NitrogenDetermination<4617>
U.S. Geological Survey Method
Cadmium

Index Terms

allogeneic; anorganic; apatite; bone; hydroxyapatite; hydroxylapatite; implant; xenogeneic; Allogeneic; Anorganic bone; Anorganic hydroxylapatite; Hydroxylapatite (HA); Orthopaedic medical devices--specifications; Orthopaedic medical devices (bone)--specifications; Xenogeneic; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Citing ASTM Standards

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