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YY 0055-2018 English PDF

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YY 0055-2018: Dentistry--Powered polymerization activators
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YY 0055: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0055-2018English359 Add to Cart 4 days [Need to translate] Dentistry--Powered polymerization activators Valid YY 0055-2018
YY 0055.1-2009English799 Add to Cart 3 days [Need to translate] Dentisitry. Powered polymerization activators. Part 1: Quartz tungsten halogen lamps Obsolete YY 0055.1-2009
YY 0055-2002English319 Add to Cart 3 days [Need to translate] Dental equipment - Powered polymerization activators Obsolete YY 0055-2002
YY 0055-1991English279 Add to Cart 3 days [Need to translate] (Curing Light) Obsolete YY 0055-1991

PDF similar to YY 0055-2018


Standard similar to YY 0055-2018

YY/T 0127.13   YY/T 0127.7   YY/T 0127.4   YY 0271.2   YY 0272   

Basic data

Standard ID YY 0055-2018 (YY0055-2018)
Description (Translated English) Dentistry--Powered polymerization activators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C33
Classification of International Standard 11.060.20
Word Count Estimation 18,149
Date of Issue 2018-09-28
Date of Implementation 2020-04-01
Issuing agency(ies) State Drug Administration

YY 0055-2018: Dentistry--Powered polymerization activators

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Dentistry--Powered polymerization activators ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Replace YY 0055.1-2009, YY 0055.2-2009 Dentistry light curing machine (ISO 10650.2015, MOD) Published on.2018-09-28 2020-04-01 implementation State Drug Administration issued

Content

Foreword I Introduction III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Category 2 5 Requirements 2 5.1 Overview 2 5.2 Irradiance 2 5.3 Electrical Safety Requirements 3 6 sampling 3 7 Test method 3 7.1 Overview 3 7.2 Irradiance 4 8 Information provided by the manufacturer 10 8.1 Instruction Manual 10 8.2 Technical Specification 11 9 mark 11 10 Packing 11 Reference 12

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0055.1-2009 and YY 0055.2-2009, and YY 0055.1-2009 and YY 0055.2-2009 In addition to the editorial changes, the main technical changes are as follows. --- Added the expression "This standard does not apply to laser or plasma arc equipment" (YY 0055.1-2009 and 1 of YY 0055.2-2009, 1) of this standard; --- Increased irradiance test requirements for 90% and 110% rated voltage of type 1 LED curing light (YY 0055.2- 5.2 of.2009, 5.2 of this standard; --- Modified the working wavelength range from 385nm to 515nm (YY 0055.1-2009 and YY 0055.2-2009) 5.2.1, 5.2.1) of this standard; --- Modified UV wavelength range from.200nm to 385nm (YY 0055.1-2009 and YY 0055.2-2009 5.2.2, this Standard 5.2.2); --- Revised the irradiance requirement of the UV wavelength range of the LED lamp to be.200mW/cm2 (5.2.2 of YY 0055.2-2009, 5.2.2) of this standard; ---Modified electrical safety requirements. from the application of GB 9706.1 part of the provisions should be in accordance with GB 9706.1, YY 0505 and IEC 80601-2-60 requirements and the addition of "if the curing light can be connected or combined with other equipment such as dental treatment machines, then The curing light should meet the requirements of GB 9706.1, YY 0505 and IEC 80601-2-60 in the connected or combined state. The light curing machine can be connected to other equipment such as dental treatment machines, and the test should be carried out under the condition of connection." (YY 0055.1-2009 and YY 0055.2-2009 5.3, 5.3 of this standard); --- Increased sampling requirements. According to new products in the industry, new "light curing devices without light guides are used. Expression of "test under conditions" (Chapter 6 of YY 0055.1-2009 and YY 0055.2-2009, No. 6 of this standard chapter); --- Removed the terms of pre-processing, repair and improvement in the 7.1 general test clauses (YY 0055.1-2009 and YY 0055.2- 7.1 of.2009, 7.1 of this standard; --- Modified the test 190nm quartz filter to.200nm quartz filter, no longer use 400nm filter (YY 0055.1- 7.2.1 of.2009 and YY 0055.2-2009, 7.2.1 of this standard; --- Revised the wavelength range of the radiometer from 190nm to 1100nm to.200nm~1100nm (YY 0055.1-2009 and 7.2.1 of YY 0055.2-2009, 7.2.1 of this standard; --- Revised the irradiance test procedure form to clarify the test time as "10s or the time specified by the manufacturer" (YY 0055.1-2009 And 7.2.2 of YY 0055.2-2009, 7.2.2 of this standard); ---Modified information and marking requirements provided by the manufacturer (Chapter 8 of YY 0055.1-2009 and YY 0055.2-2009, this Chapter 8 of the standard). This standard uses the redrafting method to modify the use of ISO 10650.2015 "dental light curing machine". This standard and ISO 10650. The main differences in.2015 are as follows. --- Modified some formatting formats in accordance with GB/T 1.1-2009; ---Delete the ISO preamble; --- For other international standards cited in this standard, if it has been converted into Chinese standards, this standard will replace the referenced international standard number with Corresponding national or industry standard number, and indicate the adoption relationship in Chapter 2 of this standard; --5.2.1385nm ~ 515nm (blue light) wavelength range of irradiance. for the specific requirements of the relevant content, delete "this standard is not regulated The repeated expression of the specific irradiance requirement for the wavelength range from 385 nm to 515 nm (preface has been described); ---7.2.1 Device. Considering the actual operation needs of the inspection work, the filter is added according to the YY 0055.1-2009 industry standard index requirements. Thickness requirements of the light sheet; ---6 Sampling. According to the new product situation in the industry, a new "light curing machine without light guiding elements is added, and the test is carried out under normal use conditions. "Expression". Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is divided into the National Technical Committee for Dental Materials and Equipment Standardization Technical Committee of Dental Equipment and Devices (SAC/TC99). SC1). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guilin City Woodpecker Medical Devices Co., Ltd., Ningbo Blue Wild Medical Therapeutic Equipment Co., Ltd. The main drafters of this standard. Li Weisong, Zhou Liangbin, Zhang Qing, Deng Yubin, Wu Yiming, Du Xiaotong, Xu Buguang. The previous versions of this standard were released as follows. ---YY 0055.1-2009, YY 0055.2-2009; ---YY 0055-2002; ---YY 0055-1991.

Introduction

This standard specifies the requirements for the optical radiation value of the light curing machine in the wavelength range of.200nm~385nm and the wavelength range above 515nm. And test methods. For the 385 nm to 515 nm wavelength range, no minimum value is given. 385nm to 515nm wavelength range value Not less than the manufacturer's specified value. This standard uses a wavelength range based on a cut-off filter. Therefore, the wavelength range of.200 nm to 385 nm includes not only the ultraviolet range, It also includes a near-blue light range with a wavelength around 380 nm. The wavelength range of 385 nm to 515 nm is considered to be the wavelength range of photocuring. The wavelength range of 515nm~1100nm is the detection limit of the detectors involved in this standard. The test methods provided in this standard cannot be given absolutely. The logarithmic value does not reflect the energy similar to blackbody radiation. The data obtained is not a true radiance value, but a test provided using this standard. The value obtained by the method. However, the data obtained by these methods should be used in conjunction with this standard. This standard cites the general standard for medical electrical equipment safety GB 9706.1, correspondingly, the applicable place marked GB 9706.1 corresponding chapter Article number. Dentistry light curing machine

1 Scope

This standard specifies that in the wavelength range of 385nm~515nm, it is used to irradiate and cure dental clinical polymer-based repair materials. The requirements and test methods for the light curing machine. This standard applies to quartz tungsten halogen lamps and light-emitting diode (LED) lamps. The light curing unit can be powered by an internal power source (rechargeable battery) or Use a connected external power supply (network power supply). This standard does not apply to laser or plasma arc equipment. This standard does not apply to light curing machines used in dental laboratories for indirect restorations, veneers, dentures and other oral products. this The relevant provisions of the standard are prioritized over the requirements of GB 9706.1.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1.1988, IDT) GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)] YY/T 0466.1 Medical devices for use in medical devices - Labels, labels and symbols for information - Part 1. General requirements (YY/T 0466.1-2016, ISO 15223-1.2012, IDT) YY 0505 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standard. Electromagnetic Compatibility Requirements and Test (YY 0505-2012, IEC 60601-1-2.2004, IDT) YY/T 0628 dental equipment graphic symbol (YY/T 0628-2008, ISO 9687.1993, IDT) IEC 80601-2-60 Medical electrical equipment - Part 2-60. Particular requirements for basic safety and basic performance of dental equipment (Medical electricalequipment-Part 2-60. Particularrequirementsforthebasicsafetyandessentialperformance Ofdentalequipment)

3 Terms and definitions

The following terms and definitions as defined in GB/T 9937 and GB 9706.1 apply to this document. Note. This clause corresponds to Chapter 3 of IEC 60601-1.2005 A1.2012. 3.1 Light curing machine poweredpolymerizationactivator It mainly emits light in the wavelength range of 385nm~515nm, which is used for dental base filling, repairing, and sealing material polymerization. device. 3.2 LED light-emittingdiodelamps A semiconductor-based illumination source. 3.3 Fully charged battery fulychargedbattery The battery is initially 100% fully charged.

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