YY 0623-2008Test method of soluble fluoride of dental materials (English PDF)
牙科材料可溶出氟的测定方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
April 25, 2008
Implementation date
December 1, 2009
Scope
YY 0623-2008 is the English-translated version of 牙科材料可溶出氟的测定方法.
YY 0623-2008 is the Chinese pharmaceutical industry standard that gives the method for determining the soluble fluoride of dental materials, both the fluoride the material releases directly into water and the fluoride that dissolves in water after the material has been treated in one of the ways described.
It sets out the specimens, the immersion and its conditions, the measurement of the fluoride released and the calculation and reporting of the result, and it applies to dental adhesives and to the preventive materials whose fluoride release is claimed. Issued on 25 April 2008, it has applied since 1 December 2009.
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Document preview — YY 0623-2008
National Standard of the People's Republic of China
- ICS
- 11.060.10
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Introduction
- 1 Scope
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
2.2.5 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.
2.2.1 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)
2.3 Detection Environment
Detecting environment for 23 °C ± 2 °C.
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 °C 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 603-1988Chemical reagent - Preparations of reagent solutions for use in test methods
- GB/T 6682Water for analytical laboratory use - Specification and test methods
GB 8372-2001 · ISO 11609-1995 · �����ǻҽѧ
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