YY 0585.3-2018Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters (English PDF)

5.1 Transparency

The filter housing shall be transparent and, when tested according to A.1 of Appendix A, shall be able to distinguish the interface between water and air.

5.2 Particulate contamination

Infusion filters shall be manufactured under conditions of minimal particulate contamination. The inner surface shall be smooth and clean. When tested according to A.2, the contamination index shall not exceed the specified value.

5.3 Connection strength

When tested according to A.3, the infusion filter shall be able to withstand a static axial tensile force of not less than 15 N for 15 s.

5.4 Leakage

The filter housing shall be impermeable to microorganisms and liquids. The filter membrane and its connection to the housing shall not be broken. When tested according to A.4, there shall be no leakage of air or water.

5.5 Connectors with internal and/or external tapered joints

The connector shall have an internal tapered joint and/or an external tapered joint conforming to GB/T 1962.2.

5.6 Protective caps

GB 8368 applies.

9.1 General provisions

Labels shall comply with the provisions of 9.2 and 9.3. Graphic symbols, if used, shall comply with YY/T 0466.1.

Note. The symbol 2725 of ISO 7000 can be used to indicate the presence of a substance of concern, by replacing "×××" with the abbreviation of the substance, and crossing out the symbol if the substance of concern is not present.

9.2 Unit container

The unit container shall be marked with at least the following information.

a) Manufacturer's name and address;

b) Description of the content, such as infusion filter for single use;

c) Infusion filter free of pyrogens, or infusion filter free of bacterial endotoxins;

d) Graphic symbol given in YY/T 0466.1, indicating that the infusion filter is sterile;

e) Lot number, beginning with the word "LOT" or using the graphic symbol from YY/T 0466.1;

f) Corresponding text or graphic symbol given in YY/T 0466.1 indicating the expiration date (year and month);

g) Infusion filter for single use only, or equivalent in words, or in graphic symbols conforming to YY/T 0466.1;

h) Instructions for use, including warnings such as checking if the protective cover has come off;

i) The letter "P" representing pressure, which shall be larger than the surrounding text.

If the area of a unit container is too small to provide all the information and/or symbols, the information can be simplified to e) and f). In this case, the information required in this clause shall be provided on the label of the next larger shelf or multi-unit container.