YY/T 0908-2013Single-use filter for syringe (English PDF)

6.3 Metal ion

When testing according to 5.6.1 in GB/T 14233.1-2008, the color of the test solution shall not exceed the standard control solution with mass concentration of rho(Pb2+)=1µg/mL.

When testing according to atomic absorption spectrophotometry in GB/T 14233.1-2008, the content of cadmium shall not exceed 0.1µg/mL.

6.4 pH

Carry out the test according to acidity meter method in GB/T 14233.1-2008, and the pH difference between the test solution and the blank solution shall not exceed 1.0.

6.5 Residual amount of ethylene oxide

If ethylene oxide is used for sterilization, after the filter is sterilized, when it is tested according to GB/T 14233.1-2008, the residual amount shall not exceed 10µg/g.

7.1 General

For the filter, when new products are put into production, when material changes significantly, the biological evaluation of cytotoxicity, irritation or intradermal reaction, sensitization, acute systemic toxicity, pyrogenic reaction and hemocompatibility shall be carried out according to GB/T 16886.1.

7.2 Sterilization

The filter shall be sterilized by a sterilization-validated process and routine controls.

NOTE 1: See GB 18278, GB 18279 and GB 18280 for suitable sterilization confirmation and routine control.

NOTE 2: Sterility test methods are specified in GB/T 14233.2. This method can be used for type test and is not suitable for factory inspection.

NOTE 3: If the product is provided in a non-sterile state, it shall be clearly marked on the package that "unsterilized, not for direct clinical use".

7.3 Bacterial endotoxin

When the filter is tested according to GB/T 14233.2, its content shall not exceed 20EU/piece (or piece).

8.1 Initial packaging

The initial packaging shall contain at least the following information:

a) Product name and specification marking in compliance with Chapter 3;

b) Manufacturer's name and address;

c) Product registration certificate number, implementation standard number;

d) Use the graphic symbols given in YY/T 0466.1, indicating the filter is sterile.

If the product is provided in a non-sterile state, it shall be clearly marked in red on the package: "Unsterilized, not for direct clinical use";

e) The filter is pyrogen-free;

f) The filter is for one-time use only, or equivalent instructions, or use the graphic symbols given in YY/T 0466.1;

g) Instructions for use, including checking the integrity of the package seal and warnings about detachment of the protective cover;

h) Production batch number, beginning with the word "batch" or "LOT", or using the graphic symbols given in accordance with YY/T 0466.1;

i) Expiration date, with appropriate text, or use the graphic symbols given in accordance with YY/T 0466.1;

j) Label the filter nominal pore size.

8.2 Outer packaging

At least the following information shall be on the outer packaging:

a) Product name and specification marking in compliance with Chapter 3;

b) Manufacturer's name and address;

c) Use the graphic symbols given in YY/T 0466.1 to indicate that the filter is sterile. If the product is provided in a non-sterile state, it shall be clearly marked in red on the package, "Unsterilized, not for direct clinical use";

d) Lot number, beginning with the word "batch" or "LOT", or use the graphic symbols given in accordance with YY/T 0466.1;

e) Expiration date, with appropriate text, or use the graphic symbols given in accordance with YY/T 0466.1;

f) Recommended storage conditions, if available.