ISO 17509:2016 歯科 — ハンドピース用のトルクトランスミッター | 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.

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The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.

Introduction

Based on ISO 13504, this International Standard describes accessories that are inserted into dental handpieces and that impart rotational forces from a dental handpiece to dental implants or their connecting parts.

1 Scope

This International Standard specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area.

This International Standard applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves.

This International Standard does not include the dental implant nor parts that would be connected to it.

With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.

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 1942, ISO 13504, ISO 16443 and the following apply.