ISO 5832-1:2024 手術用インプラント | 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, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents . ISO shall not be held responsible for identifying any or all such patent rights.

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

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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This sixth edition cancels and replaces the fifth edition (ISO 5832-1:2016), which has been technically revised.

The main changes are as follows:

• the introduction has been updated;
• normative references have been updated;
• the requirement for silicon in Table 1 has been changed to 0,75 max;
• the requirement for cobalt in Table 1 has been added;
• requirements for mechanical properties in Table 4 have been updated;
• this document has been harmonized with the ISO 5832 series.

A list of all parts in the ISO 5832 series can be found on the ISO website.

Introduction

While no known surgical implant material has ever been shown to cause absolutely no 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 when the material is used in appropriate applications. However, this document covers the raw material and not finished medical devices ここで, the design and fabrication of the device can impact biological response.

1 Scope

This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

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 6892-1 and the following apply.

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

Bibliography