YY/T 1642-2019Single-use medical protective hood (English PDF)

4.3.6 Antistatic property

The carried charge of the protective hood shall not be greater than 0.6 µC/piece.

4.3.7 Electrostatic attenuation property

The electrostatic attenuation time of the main material of the protective hood shall not exceed 0.5 s.

4.3.8 Breaking strength

The breaking strength of the main material of the protective hood shall not be less than 40 N.

4.3.9 Elongation at break

The elongation at break of the main material of the protective hood shall not be less than 15%.

4.4 Luminous transmittance and haze

4.4.1 Luminous transmittance

The eye-protection lens's luminous transmittance to visible light shall not be less than 90%.

4.4.2 Haze

The haze of the eye-protection lens shall be <=4%.

4.5 Flame retardant property

The flame retardant property of the protective hood material shall meet the following requirements:

a) Damaged length is not more than 200 mm;

b) Afterflame time does not exceed 15 s;

c) Afterglow time does not exceed 10 s.

4.6 Microbiological index

4.6.1 The microbiological index of non-sterile protective hood shall meet the requirements of Table 2.

TAKE 3 samples and inspect them visually. The results shall meet the requirements of 4.2.3.

5.3 Properties

5.3.1 Impermeability to water

Carry out the test according to the method of GB/T 4744. The results shall meet the requirements of 4.3.1.

5.3.2 Amount of water-vapour transmission

The material of the protective hood is tested in accordance with the method A desiccant method specified in GB/T 12704.1-2009. The results shall meet the requirements of 4.3.2.

5.3.3 Surface moisture resistance

The outer side of the protective hood material is tested in accordance with the spray test specified in GB/T 4745. The results shall meet the requirements of 4.3.3.

5.3.4 Resistance to synthetic blood penetration

Carry out the test according to GB 19082-2009 Appendix A. The results shall meet the requirements of 4.3.4.

5.3.5 Filter efficiency

TEST a minimum of 3 protective hood samples. According to the method of 5.7 in GB 19082-2009, determine the filter efficiency of the protective hood body and the joints respectively. The results shall meet the requirements of 4.3.5.

5.3.6 Antistatic property

Carry out the test according to the method specified in 5.9 of GB 19082-2009. The results shall meet the requirements of 4.3.6.

5.3.7 Electrostatic attenuation property

5.3.7.1 Test environment

Before testing the samples, place them in an environment with relative humidity of 50%±3% and temperature of 23 °C±1 °C for 24 h. The test is also performed under this condition.

5.7 Ethylene oxide residue

Carry out the test according to the gas chromatography specified in Clause 9 of GB/T 14233.1-2008. The results shall meet the requirements of 4.7.

6.1 Marking

6.1.1 Marking of single package of protective hood

The single package of protective hood shall have at least the following information:

a) Product name and model;

b) Design specifications and tolerances;

c) Name of the manufacturing enterprise or supplier;

d) Executive standard number or product technical requirements number;

e) Product registration number;

f) It shall be marked with the words "Please refer to the instructions before use" or relevant safety warning information;

g) Storage conditions and expiry date;

h) Production date or lot number;

i) For sterilized products, there shall be a corresponding sterilization mark. It shall indicate the sterilization method and the sterilization validity period;

j) It shall mark "single-use" or related symbols.

6.1.2 Marking of packing case

The packing case of protective hood shall have at least the following information:

a) Product name and model;

b) Name and address of the manufacturing enterprise or supplier;

c) Executive standard number or product technical requirements number;

d) Product registration number;