YY/T 1633-2019Single-use medical protective overboot (English PDF)

3.1 Single-use medical protective overboot

A type of boot-like protective cover used to protect the feet and legs of medical personnel, disease control and epidemic prevention workers, and prevent direct exposure to potentially infectious pollutants.

4.1 Structure and specification

4.1.1 The size design of the protective overboot shall be able to cover the user's feet and legs. Its size shall conform to the design size of the identification, with a tolerance of ±10%. A typical structural example of a protective overboot is shown in Figure 1.

4.1.2 The structure of the protective overboot shall be reasonable and easy to put on and take off.

4.1.3 The protective overboot shall be designed to have a form of closing, which may adopt closing modes such as elastic closing, drawstring closing, or strapping.

4.2 Appearance

4.2.1 The protective overboot shall be free of mildew spots. The surface is not allowed to have defects such as impurities, adhesion, cracks, and damage.

4.2.2 The connection part of the overboot shall be flat and tight.

5.3 Properties

5.3.1 Impermeability to water

The protective overboot material is tested in accordance with the method of

GB/T 4744. The results shall meet the requirements of 4.3.1.

5.3.2 Resistance to synthetic blood penetration

The protective overboot material is tested in accordance with the test method for resistance to synthetic blood penetration specified in Appendix A of GB 19082-2009. The results shall meet the requirements of 4.3.2.

5.3.3 Surface moisture resistance

The protective overboot material is tested in accordance with the method specified in GB/T 4745. The results shall meet the requirements of 4.3.3.

5.3.4 Breaking strength

The protective overboot material is tested in accordance with the strip method specified in GB/T 3923.1-2013. If the protective overboot is a plastic material, the test gauge distance shall be set to 50 mm. The results shall meet the requirements of 4.3.4.

5.3.5 Elongation at break

The protective overboot material is tested in accordance with the strip method specified in GB/T 3923.1-2013. If the protective overboot is a plastic material, the test gauge distance shall be set to 50 mm. The results shall meet the requirements of 4.3.5.

5.3.6 Filter efficiency

TEST a minimum of 3 protective overboot samples. According to the method specified in 5.7 of GB 19082-2009, determine the filter efficiency of the protective overboot sample and the joints of the sample respectively. The results shall meet the requirements of 4.3.6.

5.4 Microbiological index

The packing case of protective overboot 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 certificate number;

e) Specification and quantity;

f) Storage conditions and expiry date;

g) Production date or lot number.

6.2 Instructions for use

The instructions for use shall be in Chinese at a minimum and give at least the following information:

a) Uses and restrictions of use;

b) Inspections required before use;

c) Method of use;

d) Storage conditions;

e) Meaning of the symbols, color codes, and/or illustrations used;

f) It shall give possible problems and precautions;

g) Recommendations on the usage time of protective overboot;

h) Executive standard number or product technical requirements number;

i) Product registration number;

j) Disposal method after use.

7.1 Packaging

7.1.1 The protective overboot shall be packaged to prevent mechanical damage and contamination before use.