GB 19082-2023 PDF English (GB 19082-2009: Older version)
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Disposable protective clothing for medical use
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Technical Requirements for Single-Use Protective Clothing for Medical Use
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GB 19082-2023: PDF in English 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
transverse directions and conduct the test in accordance with the method specified in GB/T
3917.3. Respectively take the arithmetic mean of the test results of the longitudinal and
transverse specimens on each PCS of the protective clothing. When all the means comply with
the requirements of 4.3.1, the protective clothing shall be determined as qualified.
NOTE: the longitudinal direction refers to the length direction of the protective clothing, and the
transverse direction refers to the width direction of the protective clothing.
5.4.2 Breaking 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
transverse directions and conduct the test in accordance with the method specified in GB/T
24218.3. Respectively take the arithmetic mean of the test results of the longitudinal and
transverse specimens on each PCS of the protective clothing. When all the means comply with
the requirements of 4.3.2, the protective clothing shall be determined as qualified.
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.
5.4.4 Seam strength
Select at least 2 PCS of the protective clothing and select at least 3 straight seams from each
PCS of the protective clothing. Cut at least 2 specimens from each straight seam and conduct
the test in accordance with the method specified in GB/T 13773.2. Take the average value of
the test results of the specimens at each straight seam. The lowest value of the average value of
different straight seam positions of each protective clothing is the seam strength of the
protective clothing. When the seam strength of all the protective clothing complies with the
requirements of 4.3.4, the protective clothing shall be determined as qualified. The results shall
be reported for the selected straight seam positions and fracture positions.
5.4.5 Wear resistance
Select at least 2 PCS of the protective clothing and cut samples from non-seam parts. Cut at
least 4 specimens, and each specimen shall contain all layers. In accordance with the method in
Appendix J of GB 24539-2021, conduct the test. Select the specified hydrostatic pressure
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.
When the protective clothing design uses different materials or when different parts specify
different thicknesses, take at least 3 specimens from each material or each part.
NOTE 1: when carrying out the test in accordance with the method specified in YY/T 0689-2008,
there may be a risk of aerosol contamination on the surface of the material used to detect
phage penetration. When phage penetration is detected on the material surface and the
possibility of contamination cannot be ruled out, if the number of phage penetration is
less than 10 PFU/mL, then, it can be determined as PASS the test.
NOTE 2: when carrying out the test in accordance with the method specified in YY/T 0689-2008,
the phage suspension adopts standard samples of phage that comply with the
concentration requirements.
5.6.2 Particle filtration efficiency
5.6.2.1 Number and requirements of samples
Select at least 2 PCS of the protective clothing and cut at least 3 samples, including the seam
material, from each PCS of the protective clothing.
5.6.2.2 Detection device and conditions
The test environment is a temperature of (25 5) C and a relative humidity of (30 10)%.
The schematic diagram of the filtration efficiency detection device is shown in Figure 1, which
shall satisfy the following parameter conditions.
a) Aerosol generation system:
1) Sodium chloride particles that have been dried and charged neutralized can be
generated;
2) The aerosol concentration is not greater than 50 mg/m3, and after stabilization,
during the entire test process, the concentration change shall not exceed 10%;
3) Particle size distribution: the counting median diameter is (0.075 0.020) m,
and the geometric standard deviation of the particle size distribution is less than
or equal to 1.86.
NOTE: the counting median diameter (CMD) 0.075 m is equivalent to the mass median
aerodynamic diameter (MMAD) of approximately 0.3 m.
b) The flow range of the detection is 5 L/min ~ 100 L/min, and the accuracy is 2%.
5.6.2.3 Detection method
The flow rate of detection is (15 2) L/min and the cross-sectional area of the air flow is 100
cm2. When all detection results comply with the requirements of 4.5.2, the protective clothing
shall be determined as qualified.
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
5.8.1 Number and requirements of samples
Cut at least 3 samples from at least 2 PCS of the protective clothing. The size is 105 mm 50
mm.
5.8.2 Detection method
The schematic diagram of the flammability detection device is shown in Figure 2. The height
of the sample holder shall be adjustable and can move horizontally or circumferentially.
After igniting the burner, adjust the flame, so that the flame height at the top of the burner
reaches (40 4) mm. At (20 2) mm above the top of the burner, use a thermocouple probe
with a diameter of approximately 1.5 mm to measure the flame temperature, which shall be
(800 50) C.
During the test, the outside of the protective clothing material faces the flame, so that the 105
mm edge of the sample is perpendicular to the direction of sample movement, and the distance
of the sample passing above the flame is 50 mm. At a motion linear speed of (60 5) mm/s,
pass the flame, and record the combustion state of the sample after passing through the flame
once.
method.
5.11.2 Microbiological limits
In accordance with the membrane filtration method specified in the Microbial Enumeration
Method (General Chapter 1105) in the microbial limit inspection of non-sterile products in 4
volumes of Pharmacopoeia of the People’s Republic of China (Edition 2020), carry out the test.
Add together the total number of aerobic bacteria, mildew and yeast to obtain the total number
of microorganisms.
Preparation of test solution: randomly select at least 2 minimum packages, take no less than 10
g of the test article and cut it into pieces. Then, use a diluent containing 0.1% (volume fraction)
polysorbate 80 (or other non-bacterial surfactant), for example, pH 7.0 sterile sodium chloride
- peptone suffer, or pH 7.2 phosphate buffer, or 0.9% sterile sodium chloride solution, prepare
into a 1 : 50 (g/mL) test solution, and thoroughly mix it.
5.12 Ethylene Oxide Residue
In accordance with the method specified in 9.4 in GB/T 14233.1-2022, carry out the test.
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:
a) Product name;
b) Model and specifications;
c) Production date and (or) batch No.;
d) Service life or expiry date;
e) Manufacturer’s name and contact information;
f) Serial No. of implemented standard or serial No. of product technical requirements;
g) Product registration certificate No.;
h) The character or symbol of “disposable”;
i) If it is a sterilized product, it shall have a sterilization mark and indicate the mode of
sterilization;
j) The character or symbol of “see instructions for use for additional information”.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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