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    ASTM F1581 - 08(2020)

    Standard Specification for Composition of Anorganic Bone for Surgical Implants

    Active Standard ASTM F1581 | Developed by Subcommittee: F04.13

    Book of Standards Volume: 13.01

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    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).2 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location.

    1.6 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. (See Appendix X2).

    1.7 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D513 Test Methods for Total and Dissolved Carbon Dioxide in Water

    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

    E1184 Practice for Determination of Elements by Graphite Furnace Atomic Absorption Spectrometry

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F1185 Specification for Composition of Hydroxylapatite for Surgical Implants

    United States Pharmocopeia

    Arsenic <211>

    Cadmium <461>

    Heavy Metals <231>

    Identification Tests for Calcium and Phosphate <

    Lead <251>

    Mercury <261>

    U.S. Geological Survey Method


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F1581-08R20

    Citation Format

    ASTM F1581-08(2020), Standard Specification for Composition of Anorganic Bone for Surgical Implants, ASTM International, West Conshohocken, PA, 2020, www.astm.org

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