YY/T 1282-2022Intravenous catheter for single use (English PDF)

3.1 Distal end

The last part that the catheter is inserted into the patient's vein as far as possible.

3.2 Outside diameter of the catheter

The maximum outer diameter of the catheter.

3.3 Effective length of the catheter

The maximum length the intravenous catheter can be inserted into a patient's vein.

NOTE. See l in Figure 1 of YY 0285.1-2017.

3.4 Infusion port

The interface intended to be connected to infusion, transfusion or injection equipment.

NOTE. Generally, there are 6% Luer conical connectors, puncture connectors (heparin caps), needle-free interface connectors (including positive pressure types), etc.

3.5 Multi-way stopcock

An assembly that can open a certain passage while closing all other passages, thereby achieving switching between multiple passages.

3.6 Vent fitting

A connector used to expel gas and limit or better prevent blood flow, divided into fixed and movable types.

3.7 Extension tube

A pipeline in which one end of the intravenous catheter is connected to the catheter seat, and the other end is connected to the infusion port.

3.8 Catheter unit

An assembly consisting of the catheter, catheter hub, extension tube (if any), and any integral connectors.

3.9 Needle unit

An assembly consisting of a needle barrel and needle hub and/or any integral accessories.

3.10 Flashback

Blood flows into the needle hub or catheter.

3.11 High-pressure angiographic catheter

An intravenous catheter for injecting contrast medium into a peripheral vein.

5.1 Particulate contamination

When tested according to Annex A, the contamination index of the intravenous catheter should not exceed 90.

5.2 Specifications

5.2.1 The outer diameter of the catheter of the intravenous catheter shall comply with the requirements of Table 1.The catheter unit shall have a color code in accordance with the requirements of Table 1.

When the blocking device is in the blocking state, a hydraulic pressure of 20 kPa is passed through it for 15 s and no liquid should pass through.

5.4 Needle unit

5.4.1 Needle tube

If steel pipes are used, they should comply with the requirements of GB/T 18457.

5.4.2 Needle tip

When examined with normal or corrected vision at 2.5 times magnification, the needle tip should be sharp, without curling, notches or hooks.

NOTE 1.Annex C of YY 0285.5-2018 gives examples of typical needle tip geometries.

NOTE 2.Annex B provides a method for evaluating the puncture performance of an intravenous catheter and catheter when they are in harmony.

5.4.3 Connection strength

When tested according to Annex A of YY 0285.5-2018, the needle tube should not be loose in the needle seat.

5.5 Lubricant

If catheters and needles are lubricated, there should be no visible accumulation of lubricant on the outer surfaces of the catheters and needles as observed with normal or corrected vision.

5.6 Flow rate

When tested according to Annex E of YY 0285.1-2017, the flow rate of a conduit with a nominal outer diameter less than 1.0 mm should be no less than 80% of the manufacturer's nominal value. The flow rate of a conduit with a nominal outer diameter greater than or equal to 1.0 mm should be no less than 90% of the manufacturer's nominal value.

5.7 Venting

If the intravenous catheter has a vent fitting, when tested according to Annex D of YY 0285.5-2018, there should be no liquid leakage from the vent fitting within 15 s.

5.13 Protective piece

The catheter end of the intravenous catheter and the Luer taper connector should have a protective piece. The protective piece should be firm but easy to remove.

5.14 Anti-needlestick protection device

The intravenous catheter should be equipped with anti-needlestick protection devices.

If there is an anti-needlestick protection device, it should comply with the requirements of ISO 23908.

7.1 Biocompatibility

Intravenous catheters should be subjected to biological evaluation according to the requirements of GB/T 16886.1.The evaluation results should indicate that they are free of biological hazards.

7.2 Sterility

The sterility of intravenous catheters should comply with the requirements of YY/T 0615.1.

7.3 Bacterial endotoxins

When testing according to Chapter 4 of GB/T 14233.2-2005, use an endotoxin-free syringe to draw 5 mL of extraction medium and connect it to an indwelling catheter.

Inject the solution into the lumen of the intravenous catheter until full, then seal the distal end of the catheter. Place the syringes together in a 37°C incubator and allow them to incubate for 1 h. Push the remaining extraction medium in the syringe through the lumen of the intravenous catheter. Cut the catheter at the base. Place the cut catheter in the collection solution. Place the syringe in a 37°C incubator and incubate for 1 h.

Collect the entire extract for testing. The bacterial endotoxin limit should be less than 0.5 EU/mL.

NOTE. YY/T 0618 provides Test methods for bacterial endotoxins of medical devices - Routine monitoring and alternatives to batch testing.

8.1 Product marks

High-pressure angiographic catheters should be marked with a high-pressure resistance mark.

NOTE. Words or colors such as "High pressure resistant" or "P" can be used for identification.

8.2 Single packaging mark

At least the following clearly identifiable information should be provided on the single package.

a) Description of contents (name, catheter outer diameter and length, etc.);

b) For single use only, or equivalent;

c) Sterility;

d) Method of sterilization;

e) Radiopaque, if applicable;

f) Color code, unless the product's color code is visible through the individual packaging;

g) Batch number;

h) Date of manufacture, expiration date, or date of expiration;

i) Nominal flow rate;

j) Maximum nominal pressure for high-pressure angiographic catheter;

k) Manufacturer's name and address.

NOTE 1.The graphic symbols given in YY/T 0466.1 can be used to meet the above requirements.

NOTE 2.ISO 7000 symbol 2725 can be used to indicate the presence of a substance of concern by replacing "XXX" with the abbreviation of the substance. If the substance of concern is not present, a cross is placed on the symbol.