YY 0055.2-2009Dentistry—Powered polymerization activators - Part 2: Light-emitting diode(LED)lamps (English PDF)

Foreword

YY 0055 "dental curing light" is divided into two parts. Part --- Article l. quartz tungsten halogen lamps;

--- Part 2. light-emitting diode (LED) lights. This is Part 2 YY 0055 of.

The partial modification of the use of ISO 10650-2:2007 "dental curing light - Part 2. Light-emitting diode (LED) lamps." This part of ISO 10650-2:2007 The main differences are as follows.

a) The 5.2.2 190nm ~ 385nm wavelength range of radiation require modification to "not more than 1000W/m² (100mW/cm2)".

The main reason of this article is a modified 190nm ~ 385nm wavelength range of radiation on the human body will produce near-UV hazard, reference

GB Z2-2002 "workplace harmful factors occupational exposure limit" requirement to be modified;

b) Increase Reference GB 7247.1-2001 "Safety of laser products - Part 1. Equipment Classification, Requirements and User's Guide (Idt IEC 60825-1:1993) ";

c) ISO 10650-2:2007 standard is used in the third edition of IEC 60601-1, and this is part of the GB 9706.1-2007 (Identical with IEC 60601-1 second edition). Appendix A normative appendix.

This part of the jurisdiction of the National Dental Materials and Devices Equipment Standardization Technical Committee dental equipment and instruments at the Technical Committee.

This section is drafted. Ningbo Aino Medical Devices Co., Ltd., the State Food and Drug Administration of Quality Supervision, Inspection Guangzhou Medical Devices Test center.

Introduction

This section provides LED curing light at 190nm ~ 385nm wavelength range and radiation values over the wavelength range of 515nm Requirements and test methods. For 400nm ~ 515nm wavelength range of light radiation value, this section does not give a specific numerical requirements.

This section uses based on the wavelength range of cut-off filters. Thus, 190nm ~ 385nm wavelength range including not only the ultraviolet range, But also in the vicinity of 380nm wavelength near blue range. 400nm ~ 515nm wavelength range is considered to be the blue range of light curing unit.

Above about 515nm to 1100nm wavelength range, is this part of the detection limit of the detector involved, it does not show on the 1100nm to Radiation wavelength range that may arise can not be concerned.

Test methods provided in this section (do not rule out the application of this standard the parties to seek a more suitable method may be) can not give absolute numbers Value and does not reflect a similar energy blackbody radiation. The obtained data is not real radiation value, but the use of the test side provided in this section Method to obtain a relative value. However, the data obtained by these methods should be used in conjunction with this section.

This section refers to general medical electrical equipment safety standard GB 9706.1-2007, corresponding, where applicable label GB 9706.1-2007 Corresponding clause number. Dental Curing Light Part 2. Light-emitting diode (LED) lamp

1 Scope

This part YY 0055 provisions of the wavelength of blue light emitting diodes as a light source in the dental practice for polymer-base Requirements and test methods for repairing material was irradiated to cure the light-curing unit (hereinafter referred to as LED curing light) of.

This section does not apply to dental laboratories used for indirect restorations, LED light curing dental films, dentures and other dentistry applications Of the machine.

When this section specified, this takes precedence over section GB 9706.1-2007.

2 Normative references

The following documents contain provisions which, through reference in this section YY 0055 constitute provisions of this section. Cited documents dated, its All subsequent amendments (not including errata content) or revisions do not apply to this section. However, to encourage an agreement under this Part Whether the parties can study the latest versions of these documents. For undated references, the latest edition (including any increase S) apply to this section.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)

YY 0055.1-2009 dental curing light - Part 1. Quartz tungsten halogen lamps (YY 0055.1-2009, ISO 10650-1. 2004, IDT)

ISO 1942 Dental Terminology

3 Terms and Definitions

ISO 1942, YY 0055.1-2009 and GB 9706.1-2007 to establish the following terms and definitions apply to the YY 0055 This section.

5 Requirements