ISO 3630-4:2023 歯科 — 歯内療法器具 — Part 4: 補助器具 | 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.

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental 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 3630-4:2009), which has been technically revised.

The main changes are as follows:

• rasps requirements have been removed;
• a cyclic fatigue test of paste carriers has been added;
• the term cannula has been added;
• the cannula symbol has changed;
• Annexes A and B have been added.

A list of all parts in the ISO 3630 series can be found on the ISO website.

1 Scope

This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling.

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 1942, ISO 3630-1 and the following apply.

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

Bibliography