ASTM F1185 - 03(2014)

    Standard Specification for Composition of Hydroxylapatite for Surgical Implants

    Active Standard ASTM F1185 | Developed by Subcommittee: F04.13

    Book of Standards Volume: 13.01


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    ASTM F1185

    Abstract

    This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography. A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 %. The concentration of trace elements such as arsenic, cadmium, mercury, and lead shall be determined for hydroxylapatite derived from natural resources. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials. Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods mentioned shall be used.

    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 chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.)

    1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6) .

    1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.

    1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.)

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

    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 and health practices and determine the applicability of regulatory limitations prior to use.


    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

    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 Bone

    F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation

    F2024 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

    National Formulary

    TribasicCalciumPhosp

    United States Pharmacopeia

    Arsenic<211>

    HeavyMetals<231> Method 1

    IdentificationTestsf

    Lead<251>

    Mercury<261>

    U. S. Geological Survey Method

    Cadmium

    American Society for Quality

    C1 Specification of General Requirements for a Quality Program


    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)


    DOI: 10.1520/F1185

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