This Standard specifies the requirements, test methods, markings, instructions, packaging and storage of single-use protective clothing for medical use.
This Standard is applicable to single-use protective clothing (hereafter referred as Protective Clothing for simplicity) with obstruction or protection functions against potential infectious substances such as patient blood, body fluids, secretions and particulate matter in air, with which the medical staff may come into contact as part of their work.
Test Method
1. Appearance
1.1 Visual check; requirements in 4.1.1 shall be met.
1.2 Visual check and measurement of needle pitch with a general gauge; the requirements in 4.1.2 shall be met.
1.3 The slider fasteners of each piece of protective clothing shall be operated five times, with a total of three pieces tested; the requirements in 4.1.3 shall be met for all of the pieces.
2. Structure
Visual check; the requirements in 4.2 shall be met.
3. Size designation
A sample of each size shall be measured using general measuring tools, with a total of 3 pieces tested; the requirements in 4.3 shall be met for all.
4. Liquid obstruction function
4.1 Permeability to water
The critical parts of the protective clothing shall be tested at the hydrostatic pressure specified in GB/T4744-1997; the requirements in 4.4.1 shall be met.
4.2 Moisture infiltration level
The materials of protective clothing shall be tested in accordance with method A - moisture adsorption defined in GB/T 12704-1991; the requirements in 4.4.2 shall be met .
4.3 Penetration against synthetic blood
The materials of the protective clothing shall be tested in accordance with the method described in Appendix A; the requirements in 4.4.3 shall be met.
4.4 Surface moisture resistance
The outside surfaces of the protective clothing materials shall be tested with the spray test defined in GB/T 4745-1997; the requirements in 4.4.4 shall be met.
5. Breaking strength
The critical parts of the protective clothing shall be tested with the strip method specified in GB/T3923.1-1997; the requirements in 4.5 shall be met.
6. Crack elongation rate
The critical parts of the protective clothing shall tested with the strip method specified in GB/T3923.1-1997; the requirements in 4.6 shall be met.
7. Filtering efficiency
At least three samples of protective clothing shall be tested; the requirements in 4.7 shall be met for all. Perform the test using a sodium chloride or similar solid aerosol particle count mean diameter(CMD)b: 0.075m±0.020; particle distribution geometrics standard deviation 1.86; concentration 200mg/m3] under relative humidity 30%±10% and temperature 25°C±5°C. The air flow rate shall be set as 15 L/min±2L/min; air flow through a sectional area of 100cm2.b Equivalent to the aerodynamics mass mean diameter (MMAD) 0.24m±0.06m
8. Flame retardant properties
The flam retardant properties of the protective clothing shall be tested with the vertical method specified in GB/T 5455-1997; the requirements in 4.8.14.8.3 shall be met.
9. Antistatic properties
The test shall be performed in accordance with the method specified in Section 7.2 of GB/T 12703-1991; the requirements in 4.9 shall be met.
10. Electrostatic decay performance
The test shall be performed in accordance with the method specified in IST 40.2-01.
10.1 Test environment
Before the test, the sample shall be placed for 24h under relative humidity 50%±3% and temperature 23°C±1°C. The test shall also be performed under the same conditions.
10.2 Sampling
A sample shall be taken from each of the critical parts of the protective clothing, 89mmX(152±6)mm in size. During the sampling process, latex or cotton gloves should be worn to prevent pollution on the sample surfaces.
10.3 Test
The samples under test should be mounted onto an accurate meter that can generate at least 5,000V positive and negative voltages. A 5000V voltage should be applied to the sample and the charge decay time then measured. The requirements in 4.10 shall be met for all five samples.
11.Skin irritation
11.1 Leaching media
0.9%sodium chloride injection
11.2 Preparation of leaching solution
Under aseptic conditions, two samples sized 2.5cm×2.5cm should be cut from the protective clothing.
The leaching solution should be added at a ratio of 1mL/cm2, and leach for 72h at 37°C. A leaching solution containing no sample under test should be using the same method to act as a negative contrast solution.
11.3 Test
The test should be performed in accordance with the method specified in Section 6.3 of GB/T16886.10-2005; the requirements in 4.11 shall be met.
12.Microbiological specifications
12.1 The protective clothing should be tested in accordance with the method specified in Appendix B of GB 15979-2002; the requirements in 4.12.1 shall be met.
12.2 The asepsis test should be performed in accordance with the method specified in Section 3 of GB/T 14233.2-2005; the requirements in 4.12.2 shall be met.
13.Ethylene oxide residual quantity
The test should be performed in accordance with the method specified in Section 9, Part 3 of GB/T14233.1-1998; the requirements in 4.13 shall be met.
