ISO 10650:2018 歯科 — 電動重合活性剤 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.

This second edition cancels and replaces the first edition (ISO 10650:2015), which has been technically revised.

The main changes compared to the previous edition are as follows:

• a test procedure using spectrometer (Method A, 7.4.1) was included;
• a test procedure using filters (Method B, 7.4.2) was modified;
• an upper limit to the radiant exitance for the 380 nm to 515 nm wavelength region was added.

Introduction

This document specifies requirements and test methods in the wavelength region below 380 nm, the 380 nm to 515 nm wavelength region and the wavelength region above 515 nm for powered polymerization activators. No minimum requirement value is given for the 380 nm to 515 nm wavelength region. For the 380 nm to 515 nm wavelength region, the maximum radiant exitance has been specified in order to mitigate risks for patients.

There is a risk of tissue damage caused by heat development during photo-polymerization when sufficiently high irradiances are applied for long enough time. There is a risk of inadequate polymerization of resin-based materials when irradiated by powered polymerization activators with high radiant exitance for very short irradiation time resulting in insufficient combinations of irradiance and irradiation time. There is also a risk of inadequate polymerization of resin-based materials when irradiated with low irradiance and short irradiation time. There is no complete reciprocity between irradiance and curing time, i.e. a time threshold exists under which the polymerization will not proceed sufficiently. Therefore it is important to follow the instructions for use of the composite manufacturers.

This document refers to IEC 60601, the basic International Standard on safety of medical electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 60601.

1 Scope

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.

This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard.

This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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, IEC 60601-1 and the following apply.

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

Bibliography