ISO 13017:2020 歯科—磁気アタッチメント | 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 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 13017:2012), which has been technically revised. It also incorporates the Amendment ISO 13017:2012/Amd.1:2015. The main changes compared to the previous edition are as follows:

—addition of ISO 14233 to Clause 2;

• addition of lead as a hazardous element;
• addition of the cleaning method of test specimens prepared for retentive force;
• change of the device for retentive force to a single shaft type;
• change of Figure 3 to the single shaft type device;
• specification of the performance of the device with respect to moving friction force and modification of specimen tables;
• change of a cross-head speed in measuring retentive force from 5,0 mm min⁻¹ to 2,0 mm min⁻¹;
• addition of materials for fixing a specimen on the table such as cyanoacrylate adhesive and self-curing acrylic resin;
• deletion of the description of the adhesive double sided tape to fix a specimen on the table;
• specification of the procedures to fix a specimen on the table;
• addition of detailed method of measuring retentive force;
• addition of explaining the calculation method of retentive force;
• addition of a figure that shows a retentive force curve as Figure 4;
• specification of quantitative analyses in the static immersion test using definition of determination limit and detection limit;
• addition of “quantity” to labelling.

Introduction

The early practical uses of permanent magnets were as navigational compasses. Magnets have since become firmly integrated into today’s modern electronic device technology. The development of magnetic technology has generated rare earth magnets. Their excellent magnetic character properties permit predictable clinical applications and use. Dental magnetic attachments are one of the products composed of rare earth magnets, providing retention, support and stabilization of dental and maxillofacial appliances.

Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document, but for the assessment of possible biological or toxicological hazards, reference can be made to ISO 10993-1 and ISO 7405.

1 Scope

This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

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 10271 and the following apply.

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

Bibliography