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GB 19082-2023: Disposable protective clothing for medical use
GB 19082-2023
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
Disposable Protective Clothing for Medical Use
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
YY 0469 Surgical Mask
YY/T 0689-2008 Clothing for Protection against Contact with Blood and Body Fluids -
Determination of Resistance of Protective Clothing Materials to Penetration by Blood-borne
Pathogens - Test Method Using Phi-X174 Bacteriophage
YY/T 0700-2008 Clothing for Protection against Contact with Blood and Body Fluids -
Determination of the Resistance of Protective Clothing Materials to Penetration by Blood and
Body Fluids - Test Method Using Synthetic Blood
Pharmacopoeia of the People’s Republic of China (Edition 2020) 4 Volumes
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.
NOTE: its surface tension and viscosity can represent blood and other body fluids and has a similar
color to blood.
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.
NOTE: it is expressed in [g/(m2  h)] or [g/(m2  24 h)].
[source: GB/T 12704.1-2009, 3.1]
g/(m2  24 h).
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.
4.10.2 The total number of microorganisms of non-sterile protective clothing shall be less than
or equal to 200 CFU/g.
4.11 Ethylene Oxide Residue (if applicable)
If the protective clothing has been sterilized or disinfected with ethylene oxide, the residual
ethylene oxide content shall not exceed 10 g/g.
5 Test Methods
5.1 Test Conditions
Except for special requirements, the test shall be carried out in an environment with a
temperature of 16 C ~ 32 C and a relative humidity of (50  30)%.
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
5.4.1 Tear strength
Select at least 2 PCS of the protective clothing and cut samples from non-seam parts.
Respectively cut 3 specimens from each PCS of the protective clothing in the longitudinal and