BS ISO 13779-1:2008 - Implants for surgery. Hydroxyapatite. Ceramic hydroxyapatite – BSI British Standards

BS ISO 13779-1:2008

Implants for surgery. Hydroxyapatite. Ceramic hydroxyapatite

Status : Current   Published : June 2009

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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

 




Standard NumberBS ISO 13779-1:2008
TitleImplants for surgery. Hydroxyapatite. Ceramic hydroxyapatite
StatusCurrent
Publication Date30 June 2009
Normative References(Required to achieve compliance to this standard)ISO 10993-17, ISO 13779-3:2018, BS ISO 13779-3:2018
Informative References(Provided for Information)ISO 5961:1994, NF S 94-068, NF S 94-065, ICDD cards 9-432, 9-348, 9-169, 25-1137, 37-1497,
ReplacesBS ISO 13779-1:2000
International RelationshipsISO 13779-1:2008
DescriptorsImplants (surgical), Chemical composition, Blocks, Orthopaedic equipment, Surgical equipment, Orthopaedics, Ceramics, Hydroxides, Surgery, Calcium inorganic compounds
ICS11.040.40
Title in FrenchImplants chirurgicaux. Hydroxyapatite. Céramique à base d'hydroxyapatite
Title in GermanChirurgische Implantate. Hydroxyapatit. Keramik auf der Basis von Hydroxyapatit
CommitteeCH/150/1
ISBN978 0 580 64632 4
PublisherBSI
FormatA4
DeliveryYes
Pages12
File Size243 KB
Price£110.00


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