ISO 13179-1:2021 手術用インプラント—金属製手術用インプラントのコーティング—パート1：チタンまたはチタン-6アルミニウム-4バナジウム合金粉末から得られたプラズマ溶射コーティング | 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 ).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery.

This second edition cancels and replaces the first edition (ISO 13179-1:2014), which has been technically revised.

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

• the title and scope of the document were changed to include coatings derived from titanium-6 aluminum-4 vanadium alloy powder;
• two new terms 3.2 and 3.3 were introduced to add a distinction between vacuum plasma spraying and atmospheric plasma spraying;
• 4.2.1, three separate tables were introduced to distinguish the chemical composition limits of different coating addressed by this document;
• 4.4.3, the term shear fatigue maximum strain was corrected to shear fatigue maximum stress.

A list of all parts in the ISO 13179-1 series can be found on the ISO website.

Introduction

While no known surgical implant material has ever been shown to be completely free of adverse reactions in the human body, long term clinical experience with the material referred to in this document has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications. However, this document covers the raw material, coating structures and properties and not finished medical devices, where the design and fabrication of the device can also impact biological response.

1 Scope

This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants.

This document applies to atmospheric plasma spraying and vacuum plasma spraying.

This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying.

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 following terms and definitions apply.

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

Bibliography