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GB 19082-2009 (GB19082-2009)

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GB 19082-2009: PDF in English
GB 19082-2009
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
C 48
Replacing GB 19082-2003
Technical Requirements for Single-Use Protective
Clothing for Medical Use
ISSUED ON: MAY 06, 2009
IMPLEMENTED ON: MARCH 01, 2010
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Requirements ... 6
5 Test Methods ... 10
6 Marking, and Instructions for Use ... 14
7 Packaging and Storage ... 15
Appendix A (Normative) Test Method for Anti-Penetration of Synthetic Blood 17
Bibliography ... 22
Technical Requirements for Single-Use Protective
Clothing for Medical Use
1 Scope
This Standard specifies the requirements, test methods, marking, instructions for use,
packaging and storage of single-use protective clothing for medical use.
This Standard is applicable to single-use protective clothing for medical use
(hereinafter referred to as protective clothing) that provides barrier and protection for
medical personnel in contact with potentially infectious patients' blood, body fluids,
secretions, particulate matter in the air, etc.
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
GB/T 191 Packaging – Pictorial Marking for Handling of Goods (GB/T 191-2008,
ISO 780:1997, MOD)
GB/T 3923.1-1997 Textiles - Tensile Properties of Fabrics - Part 1: Determination
of Breaking Force and Elongation at Breaking Force - Strip Method
GB/T 4744-1997 Textile Fabrics - Determination of Resistance to Water
Penetration -Hydrostatic Pressure Test (eqv ISO 811:1981)
GB/T 4745-1997 Textile Fabrics - Determination of Resistance to Surface Wetting
-Spray Test (eqv ISO 4920:1981)
GB/T 5455-1997 Textiles - Burning Behavior - Vertical Method
GB/T 5549-1990 Surface Active Agents Determination of Surface Tension by
Drawing up Liquid Films
GB/T 12703-1991 Electrostatic Test Methods for Textile
GB/T 12704-1991 Fabrics – Determination of Water Vapor Transmission Rate -
Dish Method
GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for
Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion Transfusion Injection Equipment for
Medical Use – Part 2: Biological Test Methods
GB 15979-2002 Hygienic Standard for Disposable Sanitary Products
GB/T 16886.10-2005 Biological Evaluation of Medical Devices - Part 10: Tests for
Irritation and Delayed - Type Hypersensitivity (ISO 10993-10:2002, IDT)
IST 40.2(01) Standard Test Method Electrostatic Decay Nonwoven Fabrics
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 Particle
Solid, liquid, or solid and liquid mixed particles suspended in air, such as
microorganisms, dust, smoke and fog, etc.
3.2 Filtering efficiency
Percentage of airborne particles filtered out by protective clothing under specified
conditions.
3.3 Synthetic blood
A synthetic liquid equivalent to blood surface tension and viscosity for testing.
3.4 Protective clothing’s critical area
The front lapel, left- and right-arms, and back position of the protective clothing.
3.5 Electrostatic decay
The ability of a material to remove the charge induced to the surface of the material
when grounded.
3.6 Decay time
The time required for the induced charge to decay to 10% of the initial level, in seconds.
The fracture strength of the protective clothing’s critical area shall be no less than 45N.
4.6 Elongation at break
The elongation at break of the protective clothing’s critical area shall be no less than
15%.
4.7 Filtering efficiency
The filtering efficiency of non-oily particles at the material and joints of the protective
clothing’s critical area shall be no less than 70%.
4.8 Flame retardant properties
Protective clothing with flame retardant properties shall meet the following
requirements:
a) The damage length is no more than 200mm;
b) The after-flame time does not exceed 15s;
c) The after-glow time does not exceed 10s.
4.9 Antistatic
The charge of protective clothing shall be no greater than 0.6μC/piece.
4.10 Electrostatic decay performance
The electrostatic decay time of the protective clothing material shall not exceed 0.5s.
4.11 Skin irritation
The primary irritation score shall not exceed 1.
4.12 Microbial indicators
4.12.1 Protective clothing shall meet the requirements of microbial indicators in GB
15979-2002, see Table 4.
4.12.2 The protective clothing marked "sterilized" or "sterile" on the packaging or with
such pictorial markings shall be sterile.
requirements of 4.4.2.
5.4.3 Anti-penetration of synthetic blood
The protective clothing materials shall be tested in accordance with Appendix A, and
the results shall meet the requirements of 4.4.3.
5.4.4 Surface moisture resistance
The outer surface of the protective clothing material shall be carried out spray test in
accordance with the provisions of GB/T 4745-1997, and the results shall meet the
requirements of 4.4.4.
5.5 Fracture strength
The material of the protective clothing’s critical area shall be tested in accordance with
the strip method stipulated in GB/T 3923.1-1997, and the results shall meet the
requirements of 4.5.
5.6 Elongation at break
The material of the protective clothing’s critical area shall be tested in accordance with
the strip method stipulated in GB/T 3923.1-1997, and the results shall meet the
requirements of 4.6.
5.7 Filtering efficiency
Test at least three protective clothing samples, the results shall meet the requirements
of 4.7.
Sodium chloride aerosol or similar solid aerosol [count median diameter (CMD)1):
0.075μm±0.020μm; geometric standard deviation of particle distribution: ≤1.86;
concentration: ≤200 mg/m3]] shall be used for testing in an environment with a relative
humidity of 30%±10% and a temperature of 25°C±5°C. The air flow rate is set to
15L/min±2L/min; and the cross-sectional area through which the airflow passes is
100cm2.
5.8 Flame retardant properties
The protective clothing materials shall be carried out combustion performance test in
accordance with the vertical method specified in GB/T 5455-1997, and the results shall
meet the requirements of 4.8.
5.9 Antistatic
1) corresponds to the mass median aerodynamic diameter (MMAD) of 0.24μm ± 0.06μm.
6 Marking, and Instructions for Use
6.1 Marking
6.1.1 The minimum packaging of protective clothing shall have the following clearly
identifiable markings. If the packaging is transparent, the following markings shall also
be seen through the packaging:
a) The name of the product;
b) The name and address of the manufacturer or supplier;
c) Product size specifications;
d) The implementation standard number;
e) Product registration number;
f) If it is a sterilized product, indicate the sterilization method;
g) "Single-use" or equivalent words;
h) The date of production;
i) The storage conditions and the period of validity;
j) "Read the instructions before use" or equivalent words.
6.1.2 The packaging of protective clothing shall have at least the following markings:
a) The name of the product;
b) The name and address of the manufacturer or supplier;
c) Product size specifications;
d) The implementation standard number;
e) Product registration number;
f) The number of packages;
g) "Single-use" or equivalent words;
h) If it is a sterilized product, indicate the sterilization method;
i) The date of production;
Appendix A
(Normative)
Test Method for Anti-Penetration of Synthetic Blood
A.1 Range
This test uses synthetic blood to determine the resistance of protective clothing to
penetration of synthetic blood under different test pressures.
A.2 Method
The protective clothing material was tested with synthetic blood under continuously
applied pressure. Visually examine whether the synthetic blood penetrates the material.
A.3 Instrument
The equipment required for the test is as follows:
a) Penetration test slot in Figure A.1, and the test instrument shown in Figure A.2;
they should be made of stainless-steel;
b) The square metal blocking screen shall meet the following requirements:
● Opening rate> 50%;
● Bend under 14kPa ≤5mm;
c) A gas source that can provide the air pressure of 14kPa±1kPa;
d) Stopwatch with an accuracy of ±1s;
e) Analytical balance with an accuracy of ±0.01g;
f) A clamp capable of generating a torque of 13.5 N·m;
g) Surface tension meter.
A.4 Synthetic blood
A.4.1 Constituents
Prepare 1L of synthetic blood1) according to the formula in Appendix A of YY/T 0700-
2008:
1) The synthetic blood may be added the 2-methyl-4-isothiazolin-3-one hydrochloride (MIT) (0.5g/L) to
extend the shelf life of the solution.
......
(Above excerpt was released on 2020-03-31, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GB19082-2009