Implants for surgery. Hydroxyapatite - Ceramic hydroxyapatite

BS ISO 13779-1:2008 Implants for surgery. Hydroxyapatite. Ceramic hydroxyapatite

BS ISO 13779-1 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants. It applies to hydroxyapatite blocks. It does not apply to hydroxyapatite coatings, hydroxyapatite powder or nanoparticle-type and calcium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite.

BS ISO 13779-1 does not apply to nanoparticle-type materials.

BS ISO 13779 consists of the following parts, under the general title Implants for surgery — Hydroxyapatite:

Part 1: Ceramic hydroxyapatite

Part 2: Coatings of hydroxyapatite

Part 3: Chemical analysis and characterization of crystallinity and phase purity

Part 4: Determination of coating adhesion strength

No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in ISO 13779 has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications.

The biological response to hydroxyapatite ceramic has been demonstrated by a history of clinical use and by laboratory studies. See BS ISO 13779-1's Bibliography for more information.

Contents of BS ISO 13779-1:

• Scope
• Normative references
• Terms and definitions
• Requirements