YY/T 0328-2015A.V.fistula needle sets for single use (English PDF)

5.6.3 Lubricants

If the needle is coated with a lubricant and observed with the normal or corrected vision, there shall be no visible accumulation of lubricant on the outside surface of the needle.

Note: The suitable lubricant is undiluted polydimethylsiloxane in accordance with national pharmacopoeia. The amount of lubricant per square centimeter of the surface of the needle shall not exceed 0.25 mg.

5.6.4 Needle handle

5.6.4.1 Appearance

The appearance shall meet the following requirements.

a) The edge of the needle handle shall be complete without burrs;

b) In the appropriate position of the needle handle, it shall have the nominal outer diameter marking of the needle, the marking shall be clear.

Note: There shall be embossed buckles on the needle edge to facilitate the fingers to control the angle of the puncture needle.

5.6.4.2 Color scales

The needle handle color should be used to indicate the outer diameter of the puncture needle. It is recommended to use the color specified in Table 1.

5.6.4.3 Needle handle direction

The needle handle shall be in the same direction as the needle bevel (as shown in Figure 1).

Note: Movable needles that can rotate axially around the needle handle are not subject to this requirement, but additional indications of the direction of the bevel of the needle tip must be provided on the needle handle.

5.7 Flow-stop clip

5.7.1 The flow-stop clip on the puncture device should be a locking pin. The flow-stop clip shall be able to effectively open and close the hose. When closed, it shall be able to block the gas that is 50 kPa above atmospheric pressure for 1 min without leakage. chromium, copper, lead, and tin in the puncture test solution shall not exceed 1 µg/mL. The content of cadmium shall not exceed 0.1 µg/mL.

6.4 pH

When tested in accordance with the method of 5.4.2 of GB/T 14233.1-2008, any standard solution required for graying the indicator shall not exceed 1 mL.

6.5 Evaporation residue

When tested in accordance with them method of 5.5 in GB/T 14233.1-2008, the total amount of evaporation residues shall not exceed 5 mg.

6.6 UV absorbance

When tested in accordance with the method of 5.7 in GB/T 14233.1-2008, the absorbance of the puncture test solution in the range of 250 nm ~ 320 nm shall not exceed 0.1.

6.7 Ethylene oxide residues

When tested in accordance with the methods of clause 9 or clause 10 of GB/T 14233.1-2008, the residual ethylene oxide of each puncture device shall not exceed 0.5 mg.

7.1 Biocompatibility

The puncture device shall be evaluated biologically in accordance with the requirements of GB/T 16886.1.

7.2 Asepsis

The puncture device shall undergo a confirmed sterilization process to make the product sterile.

Note 1. Refer to the reference for suitable sterilization methods.

Note 2. GB/T 14233.2 specifies a sterile test method, but this method should not be used for exit-factory inspection. expressed in kPa.

Note: The graphic symbols given in YY/T 0466.1 may be used to satisfy the above requirements.

9.2 Middle packaging

The middle packaging shall have at least the following clearly identified information.

a) Product name, needle size and length;

b) Quantity;

c) "Sterile";

d) Lot number;

e) Year and month of failure;

f) Words or equivalent text of "single-use";

g) Requirements for handling, storage and transportation (if required);

h) The name and address of the manufacturer and/or distributor.

Note: The graphic symbols given in YY/T 0466.1 can be used to satisfy the above requirements.

9.3 Transport packaging

There must be at least the following clearly identifiable signs on the transport packaging.

a) Product name, needle size and length;

b) Quantity;

c) Words of "sterile";

d) Lot number;

e) Year and month of failure;

f) Words or equivalent text of "single-use";

g) Requirements for handling, storage and transportation;

h) The name and address of the manufacturer and/or distributor. […]