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GB/T 14233.1-2022: Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 14233.1: Historical versions
Similar standardsGB/T 14233.1-2022: Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT14233.1-2022 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 CCS C 31 Replacing GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1.Chemical Analysis Methods Issued on. OCTOBER 12, 2022 Implemented on. NOVEMBER 1, 2023 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative References... 6 3 Terms and Definitions... 6 4 General Rules... 6 5 Analysis Methods of Extractable Matters of Test Solution... 9 6 Analysis Method of Total Content of Heavy Metals in the Materials... 19 7 Content Analysis Methods of Some Heavy Metal Elements in the Materials... 20 8 Residue on Ignition... 22 9 Determination of Ethylene Oxide Residue - Gas Chromatography... 23 Bibliography... 27 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1.Chemical Analysis Methods1 ScopeThis document specifies the chemical analysis methods for the infusion, transfusion and injection equipment for medical use. This document is applicable to the chemical analysis of the infusion, transfusion, injection and supporting equipment for medical use and made of medical polymer materials. The chemical analysis of other medical polymer products can also take this document as a reference.2 Normative ReferencesThe contents of the following documents constitute indispensable clauses of this document through the normative references in this text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 601 Chemical Reagent - Preparations of Standard Volumetric Solutions GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods Pharmacopoeia of the People’s Republic of China (Version 2020) Four Volumes3 Terms and DefinitionsThis document does not have terms or definitions that need to be defined.4 General Rules4.1 Overview 4.1.1 All analyses in this document are carried out in two parallel test groups; the results shall be within the allowable relative deviation limit; the arithmetic mean shall be taken as the determination result. If one is qualified and the other is disqualified, the average calculation shall not be performed and the determination shall be re-performed. 4.1.2 Unless it is otherwise specified, all reagents used in this document are analytically pure. 4.1.3 Unless it is otherwise specified, the test water in this document shall comply with the requirements of Grade-2 water in GB/T 6682. 4.1.4 The term “room temperature” used in this document refers to 10 C ~ 30 C. 4.1.5 The term “accurate weighing” used in this document refers to weighing accurate to 0.1 mg. 4.1.6 The term “accurate measuring” used in this document refers to measuring with a transfer pipette that complies with the accuracy requirements specified in the corresponding national standards. 4.1.7 Constant weight by gravimetric method means that the weight difference of the test sample after two consecutive ignitions or dryings shall not exceed 0.3 mg. 4.1.8 Unless it is otherwise specified, the glass containers used in this document are all borosilicate glass containers. 4.1.9 Most of the analysis methods provided in this document are non-specific analysis methods, and these methods can be used for the preliminary assessment of chemical hazards of medical devices. However, if there is a situation that does not comply with the preliminary expectations in a specific test, it does not suggest that the actual risk is unacceptable, and specific analysis methods need to be adopted to identify and evaluate the safety. 4.2 Preparation of Test Solution 4.2.1 The preparation of the test solution shall simulate the conditions (such as. the application area, time and temperature of the product, etc.) that the product goes through during the using process as much as possible. The simulated extraction time shall not be less than the normal use time of the product. When the product has been used for a long time (more than 24 h), consideration should be given to prepare the test solution under accelerated test conditions, but the feasibility and rationality need to be verified. 4.2.2 The methods used for the preparation of the test solution should try to extract all the tested surfaces of the sample. 4.2.3 It is recommended to select the test solution preparation method in Table 1, and. ---If the sample preparation conditions in the brackets are used, it shall be indicated in the product standard; ---The selection of temperature should take into account the highest temperature that the product may be subject to in clinical use. For polymers, the temperature shall be selected below the glass transition temperature.5 Analysis Methods of Extractable Matters of Test Solution5.1 Clarity and Color 5.1.1 Clarity Comply with 0902 clarity inspection method of the Pharmacopoeia of the People’s Republic of China (Version 2020) Four Volumes. 5.1.2 Color Comply with 0901 solution color inspection method of the Pharmacopoeia of the People’s Republic of China (Version 2020) Four Volumes. 5.2 Reducing Substances (readily oxidizable substances) 5.2.1 Method 1.direct titration method 5.2.1.1 Principle Potassium permanganate us a strong oxidizing agent. In acidic medium, potassium permanganate reacts with reducing substances, and MnO4 is reduced to Mn2+. 5.2.1.2 Solution preparation Sulfuric acid solution. measure-take 128 mL of sulfuric acid and slowly inject it into 500 mL of water; after cooling it down, dilute it to 1,000 mL. Sodium oxalate solution [c (1/2Na2C2O4) = 0.1 mol/L]. weigh-take 6.700 g of sodium oxalate dried at 105 C ~ 110 C to a constant mass; add water to dissolve and dilute it to 1,000 mL. Sodium oxalate solution [c (1/2Na2C2O4) = 0.01 mol/L]. before use, take the sodium oxalate solution [c (1/2Na2C2O4) = 0.1 mol/L] and add water to dilute 10 times. Potassium permanganate standard titration solution [c (1/5KMnO4) = 0.1 mol/L]. in accordance with the method in GB/T 601, prepare and calibrate it. Potassium permanganate standard titration solution [c (1/5KMnO4) = 0.01 mol/L]. before use, take the potassium permanganate standard titration solution [c (1/5KMnO4) = 0.1 mol/L] and add water to dilute 10 times. If necessary, boil it, let it cool down, filter it, then calibrate its concentration.6 Analysis Method of Total Content of Heavy Metals in theMaterials 6.1 Principle In a weakly acidic solution, heavy metals, such as. lead, cadmium, copper and zinc, can react with thioacetamide to generate insoluble colored sulfides. By taking lead standard solution as the standard for colorimetric comparison, their total content can be determined. 6.2 Preparation of Reagents and Solutions Comply with 5.6.1.2. 6.3 Preparation of Test Solution Take an appropriate amount of sample and cut into pieces of 5 mm 5 mm; put it into a porcelain crucible; slowly blaze it, until it is completely charred, and let it cool. Then, add 0.5 mL ~ 1 mL of sulfuric acid to moisten it. At a low temperature, heat it, until the sulfuric acid vapor disappears. Then, add 0.5 mL of nitric acid and evaporate it to dryness; after the nitrogen oxide vapor is completely removed, let it cool. Then, at 500 C ~ 600 C, burn it to make it ash; after it cools down. Add 2 mL of hydrochloric acid, place it on a water bath and evaporate it to dryness, then add 15 mL of water. Add one drop of phenolphthalein test solution, then, dropwise add the ammonia test solution, until the above-mentioned solution turns reddish. Add 2 mL of acetate buffer solution (pH 3.5) and slightly heat to dissolve it (if there is any residue, it should be filtered with filter paper), then, transfer the solution to a 25 mL Nessler colorimetric tube; add water to make 25 mL of test solution. Place another porcelain crucible added with 0.5 mL ~ 1 mL of sulfuric acid, 0.5 mL of nitric acid and 2 mL of hydrochloric acid on a water bath to evaporate it to dryness. Add 2 mL of acetate buffer solution (pH 3.5) and 15 mL of water, slightly heat to dissolve it, then, transfer the solution to a 25 mL Nessler colorimetric tube. Add a certain amount of lead standard solution, then, use water to dilute it to 25 mL; take it as the standard control solution. 6.4 Test Procedures Respectively add 2 mL of thioacetamide test solution to the test solution and the standard control solution; shake it well and let it stand for 2 min. On a white background, observe it from above and compare the color shades. If the test solution develops color, a small amount of dilute caramel solution or other non- interfering colored solutions can be added to the standard control solution to make it consistent with the color of the sample solution.7 Content Analysis Methods of Some Heavy Metal Elementsin the Materials 7.1 Atomic Absorption Spectrophotometry 7.1.1 Sample digestion 7.1.1.1 Wet digestion. take 1 g ~ 2 g of sample, accurately weigh it and cut it into pieces of about 5 mm 5 mm; place it in a 100 mL conical flask, add 30 mL of nitric acid and 1.25 mL of sulfuric acid, shake it well and place it overnight; heat it on a hot plate for digestion. If there are still undecomposed substances or the color becomes darker when the digestion solution reaches about 10 mL, remove it and let it come down. Add 5 mL ~ 10 mL of nitric acid, then, digest it to about 10 mL for observation. Repeat this two or three times, and pay attention to avoid charring. Cool it down, add 25 mL of water, then evaporate it, until white fumes of sulfuric acid are emitted. Cool it down, then, use water to transfer the content to a 50 mL volumetric flask; add water to obtain 50 mL of test solution. Use the same method to prepare the blank control solution. 7.1.1.2 Dry-ashing. take 1 g ~ 2 g of sample, accurately weigh it and place it in a crucible. Add 10 mL of magnesium nitrate solution with a mass concentration of 150 g/L and mix it well. At low heat, evaporate it to dryness. Carefully cover 1 g of magnesium oxide on the dry residue, char it, until there is no black smoke, then, at 550 C, ash it for 4 h. Take it out and let it cool; carefully add 10 mL of hydrochloric acid (1 + 1) to neutralize the magnesium oxide and dissolve the ash (if there is any residue, it should be filtered with filter paper). Transfer it to a 50 mL volumetric flask, and add water to make 50 mL of test solution. Use the same method to prepare the blank control solution. 7.1.1.3 Other methods. reasonably formulated in accordance with the sample composition and process. 7.1.2 Instrument Atomic absorption spectrophotometer. During use, operate it in accordance with the instruction manual. 7.2 Inductively Coupled Plasma Emission Spectrometry and Mass Spectrometry 7.2.1 Instruments Inductively coupled plasma emission spectrometer and inductively coupled plasma mass spectrometer. During use, operate it in accordance with the instruction manual. 7.2.2 Analysis method (standard curve method) Within the concentration range recommended by the instrument, at least 5 standard solutions (excluding the zero point) containing the elements to be determined and with increasing concentrations in sequence shall be prepared. The concentration range of the standard solutions should consider the concentration of the element to be determined. Then, successively determine the signal value of each standard solution; draw a standard curve relative to the concentration. Determine the test solution prepared in accordance with 7.1.1 and the blank control solution. In accordance with the signal value, find out the corresponding concentration on the standard curve; calculate the content of each element. 7.3 Atomic Fluorescence Spectrometry 7.3.1 Instrument Atomic fluorescence spectrophotometer. During use, operate it in accordance with the instruction manual. 7.3.2 Analysis method Within the concentration range recommended by the instrument, at least 5 standard solutions (excluding the zero point) containing the elements to be determined and with increasing concentrations in sequence shall be prepared. The concentration range of the standard solutions should consider the concentration of the element to be determined. Then, successively determine the absorbance of each standard solution; draw a standard curve relative to the concentration. Determine the test solution and the blank control solution. In accordance with the absorbance, find out the corresponding concentration on the standard curve; calculate the content of the element.8 Residue on Ignition8.1 Test Procedures Take an appropriate amount of sample and cut it into about 5 mm 5 mm, place it in a crucible (m0) that has been burned to a constant mass, accurately weigh it and record it as m1.In a fume hood, slowly burn it, until it is completely charred, and let it cool. Add 0.5 mL ~ 1 mL of sulfuric acid to make it moist; at a low temperature, heat it, until the sulfuric acid vapor is completely removed. At 700 C ~ 800 C, burn it, until it is completely ashed. Place it in a desiccator to room temperature and weigh it. Then, at 700 C ~ 800 C, burn it to a constant mass. Weigh it and record it as m2. If the residue needs to be kept for heavy metal inspection, then, the burning temperature shall be controlled at 500 C ~ 600 C.9 Determination of Ethylene Oxide Residue - GasChromatography 9.1 Instrument Gas chromatograph. During use, operate it in accordance with the instruction manual. 9.2 Analysis Method Any gas chromatography can be used as long as the analysis is proven to be reliable. “Analytical reliability” means that when determining a device with a specified residual amount of ethylene oxide (EO), the selected analysis method has sufficient accuracy, precision, selectivity, linearity and sensitivity, and suitable for the device to be analyzed. For different products, necessary methodological evaluation is required to determine the reliability of the selected method. Other validated analysis methods may also be adopted, for example, mass spectrometry. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
