ISO 3630-5:2020 歯科 — 歯内治療器具 — Part 5: 器具の成形と洗浄 | 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 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 3630-5:2011), which has been technically revised.

The main change compared to the previous editions is as follows: D and d₃ have been harmonized with the other parts of ISO 3630.

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

Introduction

Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this document. However, in assessing possible biological or toxicological hazards, it is recommended that reference be made to ISO 10993-1 and ISO 7405.

1 Scope

This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series.

This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

2 Normative references

The following referenced documents are indispensable for the application 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 and ISO 3630-1 apply.

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

Bibliography