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Scope

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (hydroxylapatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix XI).

1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1, 2, 3, 4, 5) and by laboratory studies (6, 7, 8). Xenogeneic bone, due to its organic component, has been shown to be antigenic in the human host (9) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (10, 11).

1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.

Keywords

Allogeneic; Anorganic bone; Anorganic hydroxylapatite; Xenogeneic; anorganic bone for surgical implants-composition, spec.,; Hydroxylapatite (HA); anorganic bone for surgical implants-composition,spec.,; Orthopaedic medical devices-bone; anorganic bone for surgical implants;emcomposition, spec.,;Order Form; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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