BS ISO 13779-2:2008 Implants for surgery. Hydroxyapatite. Coatings of hydroxyapatite
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 coatings has been demonstrated by a history of clinical use and by laboratory studies. See BS ISO 13779-2’s Bibliography for more details.
BS ISO 13779-2 specifies requirements for ceramic hydroxyapatite coatings applied to metallic or non-metallic surgical implants.
Part 2 of BS ISO 13779 does not cover coatings made from glasses, glass ceramics, alpha- and beta-calcium orthophosphate or other forms of calcium phosphate, nor does it cover coatings in which the hydroxyapatite is present in a powder form.
BS ISO 13779-2 does not apply to nanoparticle-type materials.
Contents of BS ISO 13779-2:
- Scope
- Normative references
- Terms and definitions
- Requirements
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
