YY/T 0282-2009Injection needles (English PDF)

3.1 Structure type

The structure type and part name of syringe needle are shown in Figure 1.

The specifications of syringe needle product are represented in nominal diameter of needle x needle tube length and wall type and edge angle. The needle tube sizes are in mm.

Tube wall type. normal wall in RW, thin wall in TW Edge angle. long bevel angle in LB, short bevel angle in SB Marking example.

A syringe needle with tube nominal outer diameter of 0.7 mm, tube length of 32 mm, short bevel angle, thin wall is marked as.

0.7 x 32 TW SB

NOTE. When tube wall is normal and edge angle is long bevel angle, it shall not be marked.

5.1 Needle seat

5.1.1 Needle seat conical connector shall be consistent with requirements of GB/T1962.1 or GB/T1962.2.

5.1.2 With normal or corrected vision observation, the outer surface of the needle seat shall be smooth; there shall be no cracks, defects; the coating shall not fall off; the mark shall be clear.

5.2 Needle tube

5.2.1 Rigidity

When testing according to the method specified in GB/T 18457, the needle deflection value shall not exceed the provisions of Table 2.

NOTE. Needle material can also be tested if necessary.

d) volume (length x width x height);

e) product registration certificate number, the implementation standard number;

f) production lot number or production date;

g) "fragile", "afraid of rain", "up" and other words or pictorial signs in line with the relevant provisions of GB/T 191.

6.2 Instructions for use

There shall be at least the following information in the instructions for use.

a) product name

b) license number for medical device manufacturer, product registration certificate number and implementation standard number;

c) scope of application, main structure and product performance;

d) use methods, precautions;

e) other instructions and necessary warning information; f) storage conditions.

8.1 Transport

Syringe needle in the transport shall prevent heavy pressure, direct sunlight and rain and snow dip.

8.2 Storage

b) pressure sensor measuring range. 0~50 N, accuracy of ± 0.5% (full scale).

C.3 Simulated skin material

The simulated skin material shall meet the following requirements.

a) material. polyurethane film;

b) thickness. 0.35mm ± 0.05mm;

c) hardness. Shore A85 ± 10;

d) exposed area. (after clamping) equal to Phi10 mm.

C.4 Testing program

The testing shall be carried out according to the following steps.

a) place the testing needle and simulated skin at 22°C ± 2°C for at least 24 h and test at the same temperature;

b) measure the device according to Figure C.1; clamp an appropriately dimensioned simulated skin c on the jig without any significant tensile or compressive forces on the simulated skin;

c) install the testing needle on equipment a, its axis perpendicular to the plane of the simulated skin c and the tip pointing to the center of the circular puncture area;

d) set the moving speed to 100 mm/min;

e) start the testing device;

f) during the puncture-on-membrane process, measure the maximum peak force.

NOTE. Do not use punctured membranes that have been punctured in a circular puncture area.

C.5 Conformity assessment

When the maximum peak force measured is less than or equal to the value specified in Table C.1, the piercing force of the testing needle shall meet the requirements.