ISO 28888:2013 歯科—歯科用硬組織の口腔リンスの侵食の可能性をスクリーニングする方法 | 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. 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. 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.

The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.

Introduction

This International Standard describes a screening method for assessing the erosion potential of dental hard tissues associated with the use of oral rinses.

The primary aim of this International Standard is to provide methodology for screening oral rinses for the potential for tooth erosion.

Oral rinses should not cause adverse reactions to the oral soft and hard tissues when used in accordance with the manufacturer's recommendation for frequency and duration of use.

The range of known side effects and biological hazards is wide and complex. The tissue interaction with a constituent material alone cannot be considered in isolation from the overall device design. Thus, in designing an oral rinse, the choice of the best material with respect to its tissue interaction might result in a less functional product, tissue interaction being only one of a number of characteristics to be considered in making that choice. Where a material is intended to interact with tissue in order to perform its function, the biological response to this interaction can be evaluated.

1 Scope

This International Standard specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues.

The results of the screening method are intended for use in enamel and/or dentine erosion models.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 78-2, ISO 1942 and the following apply.

Bibliography