ISO 23450:2021 歯科 — 口腔内カメラ | ページ 2

Foreword

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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 ).

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 04, 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).

Introduction

In the field of dentistry, intraoral cameras have been used in the oral cavity of patients for many years. The intraoral camera provides dentists with an aid which is able to significantly improve communication with the patient, facilitate documentation and raise the diagnostics to another qualitative level.

Technological advancement enables the continuous development of new and improved intraoral cameras, the handling of which is becoming easier and the possible applications of which are becoming more extensive.

These intraoral cameras are produced by the dental industry as high-quality medical devices under recognized quality management systems.

In order to maintain this high level of quality, this document describes the applicable technical product features.

This document refers to IEC 60601-1, the basic standard on safety of medical electrical equipment, by stating the respective clause numbers of IEC 60601-1 and IEC 80601-2-60.

1 Scope

This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking.

This document is not applicable to:

• a) powered polymerization activators for polymerization of dental materials;
• b) exclusively extraoral camera equipment to prepare overviews or to record treatments;
• c) dental microscopes for minimally invasive treatments;
• d) medical endoscopes;
• e) camera handpieces for tooth illumination (transillumination);
• f) CAD or CAM scanner handpieces;
• g) combinations of dental instruments with camera functions;
• h) cameras for endodontic purposes;
• i) devices for root canal inspection (endoscopic microcameras);
• j) cameras for tool navigation;
• k) cameras for determination of tooth colour.

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 and the following apply.

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