GB 19082-2023 PDF English
US$250.00 · In stock · Download in 9 secondsGB 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 procedureStatus: Valid GB 19082: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 19082-2023 | English | 250 |
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Disposable protective clothing for medical use
| Valid |
| GB 19082-2009 | English | 155 |
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Technical Requirements for Single-Use Protective Clothing for Medical Use
| Valid |
| GB 19082-2003 | English | 559 |
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Technical requirements for single-use protective clothing for medical use
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB 19082-2023
GB 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/GB19082-2023
GB
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 Contents
Foreword... 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... 21
1 Scope
This 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 References
The 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 Clothing
3 Terms and Definitions
The 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 Requirements
4.1 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 Methods
5.1 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 Indicators
6 Markings and Instructions for Use
6.1 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 Storage
7.1 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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