ISO 23401-1:2023 歯科 — チェアサイド義歯床裏装材 — Part 1: ハードタイプの材料 | 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 documents 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 ).

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 ).

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials, 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).

A list of all parts in the ISO 23401 series can be found on the ISO website.

Introduction

The purpose of denture base relining materials is to improve the fit of dentures to the oral mucosa. The materials can reline the denture the same day. Thus, they can be a useful material for the general denture patients and especially for bedridden patients who may have no access to dental surgery.

Requirements and test methods for the soft type materials are defined in detail by ISO 10139-1 and ISO 10139-2, but it is extremely difficult to incorporate the hard type materials in these International Standards of soft lining materials because of the differences in the main components, curing mechanisms and physical properties.

Also, chairside denture base relining materials and denture base materials covered by ISO 20795-1 and ISO 20795-2 differ in terms of polymerization method and required properties. As chairside denture base relining materials are partially or even mainly handled intraorally, properties such as consistency and exothermicity during intra-oral polymerization are quite important.

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

1 Scope

This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer.

Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic.

This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials.

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 20795-1 and the following apply.

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

Bibliography