ISO 5834-3:2019 手術用インプラント—超高分子量ポリエチレン—パート3：加速劣化法 | ページ 2

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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, 2 (see www.iso.org/directives ).

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This document 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 5834-3:2005) which has been technically revised.

The main changes compared to the previous edition are as follows:

• test methods harmonized with respective ASTM standards;
• editorial updates in line with all other parts of the ISO 5834 series.

A list of all parts in the ISO 5834 series can be found on the ISO website.

1 Scope

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11542-1, ISO 11542-2 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography