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YY 0623-2008 English PDF

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YY 0623-2008: Test method of soluble fluoride of dental materials
Status: Obsolete
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Standard similar to YY 0623-2008

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Basic data

Standard ID YY 0623-2008 (YY0623-2008)
Description (Translated English) Test method of soluble fluoride of dental materials
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 7,787
Date of Issue 2008-04-25
Date of Implementation 2009-12-01
Quoted Standard GB/T 603-1988; GB 8372-2001; GB/T 6682; ISO 11609-1995; �����ǻҽѧ
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the dental materials leachable fluoride method. Within the meaning of this standard leachable fluorine, including the release of material dissolved in water directly through the various methods of fluorine and treatment, fluoride dissolved in water. This standard applies to prosthodontics, bonding, preventive health care materials leachable fluorine content.

YY 0623-2008: Test method of soluble fluoride of dental materials

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Test method of soluble fluoride of dental materials ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Dental materials leachable fluoride determination Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued

Foreword

This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment. This standard was drafted by the State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Zheng Rui Yang Lin, HE Ming Ming.

Introduction

Features of oral fluorinated material is capable of releasing fluorine in the oral cavity, free of fluorine and tooth structure hydroxyapatite to achieve the anti-caries purpose. This standard uses a fluoride ion selective electrode material eluted fluoride content, and recommends three oral fluorinated material Treatment, to extract the fluoride ion. Method One. Determination of material directly dissolved in water to release fluoride ions. Due to various oral fluorinated material in the oral environment, fluoride release The amount of release time and have a great relationship, through the release of orgasm to gradually decay to release the end of such a process. Thus, in the period of release At different times, the measured concentrations of fluorine are very different. This method can be simulated at mouth temperature conditions, after a certain period of time, measuring Release of fluoride ions, meaning anti-caries practical applications. When you select this method, the manufacturer should choose the products according to the characteristics of the product in water discharge Set time. Method 2. water-soluble fluoride acid-treated, into ionic fluorine, measuring its content. Method three. the water-soluble fluoride and sodium carbonate after burning process to produce sodium fluoride, into ionic fluorine, measuring its content. Dental materials leachable fluoride determination

1 Scope

This standard specifies the method for the determination of dental materials can be dissolved fluorine. The standard can be referred to the dissolution of fluorine, including direct material was dissolved Release fluoride in water and after different methods of treatment, fluoride dissolved in water. This standard applies to dental adhesive, preventive health care leachable material determination of fluorine content. Method 2 2.1 Equipment 2.1.1 pH meter (potentiostat). 2.1.2 fluorine compound electrodes. 2.1.3 electronic balance (0.0001g). 2.2 Reagents 2.2.1 Sodium fluoride (excellent pure or analytical). 2.2.2 cyclohexanediamine tetraacetic acid, CDTA (AR). 2.2.3 Sodium chloride (AR). 2.2.4 glacial acetic acid (AR). 2.2.5 6mol/L sodium hydroxide. 2.2.6 5mol/L hydrochloric acid. 2.2.7 10% sodium carbonate. 2.2.8 Water. Water should be consistent with GB 6682 test in three water specifications. 2.3 Detection Environment Detecting environment for 23 ℃ ± 2 ℃. 2.4 solution preparation 2.4.1 total ionic strength adjustment buffer (TISABⅡ) Take 1000mL beaker, add about 600mL of deionized water, 4.0 g of cyclohexane tetraacetic acid (CDTA), 57mL of glacial acetic acid and 58g Chloride, dissolved by magnetic stirring, set the beaker in a cold water bath, was added slowly with stirring 6mol/LNaOH, adjusted to pH 5.0 to 5.5, Into 1000mL volumetric flask, add deionized water to the mark. Sodium fluoride in the oven at 110 ℃ drying 4h, set dessicator to cool to room temperature, accurately weighed 0.222g to 1000mL volumetric flask Added deionized water and dilute to volume into polyethylene plastic bottle. This fluorine-containing solution at a concentration of 100μg/mL. 2.4.3 preparation of calibration solution and draw the calibration curve Pipette respectively amount of the above solution 0.1mL, 0.5mL, 1mL, 5mL, 10mL, 20mL, 50mL moved 100mL capacity Flask, each flask was added 20mL of total ionic strength adjustment buffer (TISABⅡ), deionized water was added to the mark. The Solution concentrations were obtained fluorine-containing 0.1μg/mL, 0.5μg/mL, 1μg/mL, 5μg/mL, 10μg/mL, 20μg/mL, 50μg/mL (You may also need to be formulated calibration solution, so that the fluorine content of the sample in the concentration of the calibration solution). The above solutions were placed 150mL polyethylene plastic cup on a magnetic stirrer, potentiometric instrument and electrode from the fluorine compound of low concentration to high concentration was followed by measuring the electrical Bit value, each potential value to be read after the numerical stability. Draw fluorine concentration on semi-logarithmic graph paper - the potential value of the curve. X-axis Potential value (unit. mV); Y-axis of the fluorine concentration (unit. μg/mL). And draw regression equation.

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