GB 19082-2023 PDF EnglishUS$250.00 · In stock · Download in 9 seconds
GB 19082-2023: Disposable protective clothing for medical use 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 19082: Historical versions
Similar standardsGB 19082-2023: Disposable protective clothing for medical use---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/GB19082-2023GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 CCS C 48 Replacing GB 19082-2009 Disposable Protective Clothing for Medical Use Issued on. NOVEMBER 27, 2023 Implemented on. DECEMBER 1, 2025 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 4 Introduction... 6 1 Scope... 7 2 Normative References... 7 3 Terms and Definitions... 8 3.1 particle filtration efficiency... 8 3.2 synthetic blood... 8 3.3 water-vapor transmission rate... 8 4 Requirements... 9 4.1 Basic Requirements... 9 4.2 Dimensions... 9 4.3 Material Physical Properties... 9 4.4 Material Liquid Barrier Function... 10 4.5 Material Resistance to Penetration by Infectious Agents... 11 4.6 Water-vapor Transmission Rate... 11 4.7 Flammability (if applicable)... 12 4.8 Antistatic Property... 12 4.9 Biocompatibility... 12 4.10 Microbiological Indicators... 12 4.11 Ethylene Oxide Residue (if applicable)... 12 5 Test Methods... 12 5.1 Test Conditions... 12 5.2 Basic Requirements... 12 5.3 Dimensions... 12 5.4 Material Physical Properties... 13 5.5 Material Liquid Barrier Function... 14 5.6 Material Resistance to Penetration by Infectious Agents... 14 5.7 Water-vapor Transmission Rate... 17 5.8 Flammability... 17 5.9 Antistatic Property... 18 5.10 Biocompatibility... 18 5.11 Microbiological Indicators... 18 5.12 Ethylene Oxide Residue... 19 6 Markings and Instructions for Use... 19 6.1 Markings... 19 6.2 Instructions for Use... 20 7 Packaging, Transportation and Storage... 20 7.1 Packaging... 20 7.2 Transportation and Storage... 20 Bibliography... 211 ScopeThis document specifies the requirements, markings, instructions for use, packaging, transportation and storage, etc. of disposable protective clothing for medical use, and describes the corresponding test methods. This document is applicable to disposable protective clothing for medical use (hereinafter referred to as the “protective clothing”) worn by personnel in medical institutions when performing medical treatment, disease prevention and control, etc. in potential risk-exposure scenarios, such as. possible contact with infectious blood, body fluids, secretion and airborne particles, etc.2 Normative ReferencesThe contents of the following documents constitute indispensable clauses of this document through the normative references in the 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 3917.3 Textiles - Tear Properties of Fabrics - Part 3.Determination of Tear Force of Trapezoid-shaped Test Specimens GB/T 4744-2013 Textiles - Testing and Evaluation for Water Resistance - Hydrostatic Pressure Method GB/T 4745-2013 Textiles - Testing and Evaluation for Water Resistance - Spray Test Method GB/T 12703.3-2009 Textile - Evaluation for Electrostatic Properties - Part 3.Electric Charge GB/T 12704.1-2009 Textiles - Test Method for Water-vapor Transmission of Fabrics - Part 1. Desiccant Method GB/T 13773.2 Textiles - Seam Textile Properties of Fabrics and Made-up Textile Articles - Part 2.Determination of Maximum Force to Seam Rupture Using the Grab Method GB/T 14233.1-2022 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1.Chemical Analysis Methods GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1.Evaluation and Testing within a Risk Management Process GB/T 20655 Protective Clothing - Mechanical Properties - Determination of the Resistance to Puncture GB/T 24218.3 Textiles - Test Methods for Nonwovens - Part 3.Determination of Tensile Strength and Elongation (strip method) GB 24539-2021 Protective Clothing - Chemical Protective Clothing3 Terms and DefinitionsThe following terms and definitions are applicable to this document. 3.1 particle filtration efficiency Under specified testing conditions, the percentage of airborne particles being filtered out by protective clothing materials. 3.2 synthetic blood A mixture of red dye, surfactant, thickener and distilled water. 3.3 water-vapor transmission rate Under the condition that both sides of the specimen maintain the specified temperature and humidity, the mass of water vapor vertically passing through the unit area of the specimen within the specified time.4 Requirements4.1 Basic Requirements The material and structural design of the protective clothing shall comply with the following requirements. 4.2 Dimensions The body length, sleeve length, chest circumference, cuffs and ankle cuffs of the protective clothing shall comply with the dimensions and tolerance requirements specified by the manufacturer. 4.3 Material Physical Properties 4.4 Material Liquid Barrier Function 4.4.1 Impermeability to water The hydrostatic pressure resistance level of the protective clothing material and the seam shall not be lower than the requirements of Level 1 in Table 2. 4.4.2 Surface moisture resistance The spray rating on the outer side of the protective clothing material shall not be lower than the requirements of Level 3 in Table 3. 4.5 Material Resistance to Penetration by Infectious Agents 4.5.1 Resistance to penetration by phage The resistance to penetration by phage shall not be lower than the requirements of Level 1 in Table 4. 4.5.2 Particle filtration efficiency The filtration efficiency of the protective clothing material and the seam for non-oily particles shall not be less than 70%. 4.7 Flammability (if applicable) If the manufacturer expressly states that the protective clothing is not flammable, the material of the protective clothing shall not melt or drip, and the burning time after leaving the flame shall not exceed 5 s. 4.8 Antistatic Property The electric charge of the protective clothing shall not be greater than 0.6 C/PCS. 4.9 Biocompatibility It shall be free of biocompatibility hazards. 4.10 Microbiological Indicators 4.10.1 Sterile protective clothing shall be aseptic.5 Test Methods5.1 Test Conditions 5.2 Basic Requirements Select at least 3 PCS of the protective clothing and visually check whether they comply with the requirements of 4.1 a) and 4.1 b). At different positions of the zipper of each protective clothing, pull the zipper on and off to check whether it complies with the requirements of 4.1 c). Conduct appearance inspection, and if necessary, actually wear it to check whether it complies with the requirements of 4.1 d). 5.3 Dimensions Select at least 3 PCS of the protective clothing. In accordance with the method specified by the manufacturer, measure the dimensions of each part. If they comply with the requirements of 4.2, the protective clothing shall be determined as qualified. 5.4 Material Physical Properties 5.4.3 Resistance to puncture Select at least 2 PCS of the protective clothing and cut samples from non-seam parts. Cut 2 specimens from each PCS of the protective clothing and conduct the test in accordance with the method specified in GB/T 20655.Respectively take the arithmetic mean of the test results of the specimens on each PCS of the protective clothing. When all the means comply with the requirements of 4.3.3, the protective clothing shall be determined as qualified. 5.4.6 Flexural damage resistance Select at least 2 PCS of the protective clothing and cut samples from non-seam parts. For each PCS of the protective clothing, respectively cut 2 specimens in the longitudinal direction and transverse direction, and each specimen shall contain all layers. In accordance with the method in Appendix K of GB 24539-2021, carry out the test, and select the specified hydrostatic pressure method to determine the end point. Respectively take the arithmetic mean of the hydrostatic pressure values of the specimens in the longitudinal direction and transverse direction on each PCS of the protective clothing. When all the means comply with the requirements of 4.3.6, the protective clothing shall be determined as qualified. 5.5 Material Liquid Barrier Function 5.5.1 Impermeability to water Select at least 2 PCS of the protective clothing and cut at least 3 specimens (including seams) from different parts of each PCS of the protective clothing. In accordance with the method specified in GB/T 4744-2013, conduct the test. Take the arithmetic mean of the hydrostatic pressure values of all the specimens of each PCS of the protective clothing. When all the means comply with the requirements of 4.4.1, the protective clothing shall be determined as qualified. 5.6 Material Resistance to Penetration by Infectious Agents 5.6.1 Resistance to penetration by phage Cut at least 3 specimens from different parts of at least 2 PCS of protective clothing. In accordance with Program C or Program D specified in YY/T 0689-2008, conduct the test. When the test results of all specimens comply with the requirements of 4.5.1, the protective clothing shall be determined as qualified. 5.6.2 Particle filtration efficiency 5.7 Water-vapor Transmission Rate Select at least 2 PCS of the protective clothing and cut at least 3 specimens from different parts of each PCS of the protective clothing. In accordance with the desiccant method specified in GB/T 12704.1-2009, carry out the test. The inner surface of the protective clothing is the test surface. Take the arithmetic mean of the water-vapor transmission rate of all specimens of each PCS of the protective clothing. When all the means comply with the requirements of 4.6, the protective clothing shall be determined as qualified. 5.8 Flammability 5.9 Antistatic Property Select at least 2 PCS of the protective clothing. In accordance with the method specified in GB/T 12703.3-2009, carry out the test. When all test results comply with the requirements of 4.8, the protective clothing shall be determined as qualified. 5.10 Biocompatibility In accordance with the method specified in GB/T 16886.1, conduct the biocompatibility evaluation. 5.11 Microbiological Indicators6 Markings and Instructions for Use6.1 Markings The minimum sales package of the protective clothing shall have a clear Chinese marking, and the content of the marking shall at least include. 6.2 Instructions for Use The instructions for use shall at least include the following content.7 Packaging, Transportation and Storage7.1 Packaging The packaging of the protective clothing shall be able to prevent mechanical damage and contamination prior to use. 7.2 Transportation and Storage In accordance with the conditions stipulated in the contract or the requirements of the instructions for use. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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