GB 19082-2023Disposable protective clothing for medical use (English PDF)

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.

4.1 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 µC/PCS.

4.9 Biocompatibility

It shall be free of biocompatibility hazards.

4.10 Microbiological Indicators

4.10.1 Sterile protective clothing shall be aseptic.

5.1 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

6.1 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.

7.1 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. […]