ISO 13402:2025 外科用および歯科用ハンド器具 — オートクレーブ滅菌、腐食、および熱暴露に対する耐性の決定 | 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.

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 170, Surgical instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 13402:1995), which has been technically revised.

The main changes are as follows:

• restructuring of the document;
• update of Clause 2;
• addition of Clause 3;
• addition of Clause 4 including a table with an overview of test methods;
• addition of Clause 5;
• addition of Annexes A to H including test methods.

Introduction

The procedures described in this document form a harmonized series of tests that can be referred to, individually or in combination, in other separate product standards. The requirements for such tests are defined and stated within the body of the product standard along with the number of cycles for each test procedure. The tests apply to dental and surgical instruments and are already standardized in relevant product standards (e.g. ISO 7151, ISO 9173-1). However, the test procedures as stated in the product standards differ in minor details. An alignment and a compilation were established.

The most important test methods for dental and surgical instruments have been compiled in this document.

1 Scope

This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

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

No terms and definitions are listed in this document.

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

Bibliography