National foreword

This British Standard is the UK implementation of ISO 13779‑1:2008. It supersedes BS ISO 13779‑1:2000 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2009.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 13779‑1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.

This second edition cancels and replaces the first edition (ISO 13779‑1:2000), which has been technically revised.

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

Introduction

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 Bibliography.

1 Scope

This part of ISO 13779 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants.

This part of ISO 13779 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.

This part of ISO 13779 does not apply to nanoparticle-type materials.

2 Normative references

3 Terms and definitions

4 Requirements

4.1 Chemical analysis

4.2 Trace elements

4.3 Crystalline phase compositions

4.4 Crystallinity value

4.5 Mechanical properties — Compression strength

Bibliography

BS ISO 13779-1:2008

Implants for surgery. Hydroxyapatite - Ceramic hydroxyapatite

Current

Published:

30 Jun 2009