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Dentistry. Powered polymerization activators. Part 2: Light-emitting diode (LED) lamps
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YY 0055.2-2009
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Basic data | Standard ID | YY 0055.2-2009 (YY0055.2-2009) | | Description (Translated English) | Dentistry. Powered polymerization activators. Part 2: Light-emitting diode (LED) lamps | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 10,154 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB 9706.1-2007; YY 0055.1-2009; ISO 1942 | | Adopted Standard | ISO 10650-2-2007, MOD | | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the order blue wavelength light-emitting diodes as the light source in the dental practice for the repair of the polymer as the base material for irradiation of the curing light curing unit (hereinafter referred to as LED light curing unit) requirements and test methods. This section does not apply to the dental laboratory used for indirect restorations, dental films, dentures and other dental applications, LED light curing unit. When there are provisions in this section, the part precedence GB 9706. 1-2007. |
YY 0055.2-2009: Dentistry. Powered polymerization activators. Part 2: Light-emitting diode (LED) lamps ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dentistry.Powered polymerization activators.Part 2. Light-emitting diode (LED) lamps
ICS 11.060.20
C33
People's Republic of China pharmaceutical industry standards
Dental Curing Light
Part 2. Light-emitting diode (LED) lamp
(ISO 10650-2.2007, MOD)
Posted 2009-11-15
2010-12-01 implementation
State Food and Drug Administration issued
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.
The main drafters of this section. Qi Yang, Liwei Song, Li Danrong, Yang Xiaoling.
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.
3.1
Based semiconductor light-emitting source.
1) See GB 7247.1-2001,3.46.
3.2
Charged to the first full charge 80% to 100% charge.
Category 4
The same LED curing light YY 0055.1 classification and classification.
5 Requirements
5.1 General requirements
YY 0055.1-20095.1 apply.
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