YY/T 1768.2-2021Needle-based injection systems for medical use-Requirements and test methods - Part 2: Needles (English PDF)

3.3 Seal

A removable barrier expected to keep the needle sterile within the needle container.

3.4 Unit packaging

The needle container and seal together make up this device packaging, so as to keep the needle sterile.

3.5 User packaging

A package used by the manufacturer to provide the user with one or more identical devices (in their single package) from the same production batch.

5.1 Size

5.1.1 General

The size of the connecting part of the needle assembly shall be such that the needle can be used in conjunction with the NIS specified in YY/T 1768.1.

5.1.2 Needle size

Use the test apparatus that complies with A.1 in Annex A. In the standard atmosphere specified in A.2, when testing needles without pretreatment in Annex B, it shall be adapted to the test gauge specified in Annex C. The size shall meet the requirements of

6.1 Test solution preparation

Immerse 25 needles with the sheath removed into 250mL of freshly prepared grade two water that meets the requirements of GB/T 6682. Keep temperature constant for 1h at (37±1)°C. Take out the needle to get the test solution. At the same time, prepare the blank control solution according to the same method as above without putting the needle.

6.2 pH

When tested according to the method specified in GB/T 14233.1-2008, the pH difference between the test solution prepared in 6.1 and the blank control solution shall not be greater than 1.

6.3 Heavy metal content (metal ions)

When measured by atomic absorption spectrophotometry (AAS) or an equivalent method, the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 5µg/mL. The content of cadmium shall not exceed 0.1µg/mL.

When tested according to the method specified in 5.6.1 of GB/T 14233.1-2008, the color of the test solution shall not exceed the color of the standard control solution with a concentration of 5µg/mL.

7.1 Sterility

The needles in the unit packaging shall meet the requirements of YY/T 0615.1.

7.2 Bacterial endotoxin

When tested according to the method specified in GB/T 14233.2-2005, the bacterial endotoxin content shall be less than 20EU/piece.

7.3 Biocompatibility

Carry out the biological evaluation of materials and/or final products on the basis of material characterization according to the evaluation procedures specified in GB/T 16886.1.

NOTE: For the consideration of animal protection, the evaluation procedure given in GB/T 16886.1 is recommended for biological evaluation. When using such an evaluation procedure, if it can be confirmed that the material of the needle tube under evaluation is equivalent to the material specified in GB/T 18457-2015, and the production process of the product is equivalent to the production process of similar products on the market; if the human intake in clinical use is lower than the tolerable limit (TI) of the substance, it can confirm that the product has good biocompatibility without the need for corresponding biological tests.

9.1 General

The needles shall be accompanied by information sufficient for safe use. It shall also consider the training and knowledge of potential users. This information shall include the manufacturer's identification.

The instructions for use shall be included in the user packaging unless the needle is safe to use without instructions.

The flow rate determined in accordance with 5.2 shall be provided on the label.

B.1 Pretreatment in hot, dry atmosphere

Put the needles in the unit packaging into the test chamber under the following conditions for at least 96h:

- Temperature: (70±2)°C;

- Relative humidity: (50±10)%.

B.2 Pretreatment in a refrigerated environment

Put the needles in the unit packaging into the test chamber under the following conditions for at least 96h:

- Temperature: (-40±3)°C.

B.3 Pretreatment in periodic atmospheric environment

Place the needles in the unit packaging into the test chamber. Process according to GB/T 2423.4-2008 and the following requirements:

- Change 1 [see Figure 2a) in GB/T 2423.4-2008];

- Lower limit of temperature: (25±3)°C (no humidity requirement);

- Upper limit of temperature: (55±2)°C;

- 6 cycles.

NOTE: The corresponding chapters in GB/T 2423.4-2008 are Chapter 4 (Test chamber), Chapter 7 (Conditional test) and Chapter 9 (Recovery).

Distilled water.

D.3 Instruments

D.3.1 Test fixture

The sample needle is mounted on it.

D.3.2 Water tank

Connect to the test fixture. It is pressurized with (1.1±0.01) bar compressed air.

NOTE: 1bar=100kPa. A pressure of 1.1 bar is considered to best simulate the average situation of the user.

D.4 Steps

Add (23±2)°C water to the water tank. Connect or screw the test needle into the test fixture attached to the tank.

Make water flow through the needle for at least (15±0.25)s. Collect the effluent in a suitable container.

Convert the effluent to its volume by weighing the effluent. The density of water is assumed to be equal to 1.000g/mL.

NOTE: Tolerances for temperature, pressure and time have been chosen to consider what is usually achievable, although they are believed to have different effects on the overall tolerance.

D.5 Result expression

Test results are reported in milliliters per minute (mL/min).

The water temperature in the fluid path shall not exceed 25°C.

F.1 Principle

Apply the specified torque to the needle and connect it to the NIS for at least 10s. Use dose test to determine the integrity of clinically relevant fluid pathways. (In the settings of NIS Vhigh and Vlow, where Vlow is less than or equal to 10% of NIS maximum dose, and Vhigh is greater than or equal to 90% of NIS maximum dose.)

Finally, measure and record the removal torque of the needle seat.

F.2 Instruments and devices

F.2.1 Torque tester

It is capable of holding needles and NIS securely (for threaded needles). The instrument shall be able to apply (0.07±0.01) N·m of assembly torque (clockwise). The resolution is ±0.001N·m. This instrument shall also be able to apply disassembly torque (counter- clockwise) and record the peak results. If the needle has no thread, the relevant assembly and disassembly tests shall meet the relevant requirements.

F.2.2 Timer

It is capable of timing 10s with ±1s resolution.

F.2.3 Dose accuracy instrument

It is capable of collecting and weighing NIS liquids from tests. The resolution is 0.0001g. The instrument shall include a laboratory balance with a protective frame and weighing pan (for information on the accuracy of dose determination, see YY/T 1768.1).

F.3 Steps

F.3.1 Needle seat - Assembly

NOTE: This is a prerequisite for the torque teardown test.

F.3.1.1 Fill the applicable cartridge into the reusable NIS (if applicable). For injection devices with integral containers and non-replaceable containers, cartridges are not used because NIS itself contains liquid.

F.3.1.2 Prime NIS with an additional needle as needed until a stream of fluid emerges from the needle tip. This is to ensure that the pusher assembly of the NIS is in contact with the piston, that is, the NIS is pre-drained. Remove the additional needle.

F.3.1.3 Insert the NIS into the needle seat torque tester.

F.3.1.4 Connect the test needle to the NIS. Apply a torque of (0.07±0.01) N·m. Record the peak assembly torque (twist on) measurement result.

F.3.1.5 Start a 10s timer. Let the assembly hold for at least 10s. Carefully remove the pen assembly from the torque tester.

F.3.2 Needle dose accuracy

F.3.2.1 Perfuse the NIS (if not already perfused) according to the manufacturer's instructions for use.

F.3.2.2 Select and set the first target dose of the NIS. This is Vlow or Vhigh set in random or alternating dose order.

F.3.2.3 Zero the balance.

F.3.2.4 Apply and maintain pressure on the NIS propulsion unit, so as to deliver the liquid dose to the measuring equipment.

F.3.2.5 Deliver the dose according to the manufacturer's instructions for use.

F.3.2.6 Stabilize the mass on the balance. Observe and record the first stable mass value within 5s after the holding time specified in the instructions for use.

Make sure the balance is zeroed before each dose. When a new weighing pan is required, add a portion of the liquid. Put it on the balance and tare it.

F.3.3 Needle seat removal torque

F.3.3.1 Carefully replace the NIS in the torque test apparatus. Unscrew the needle thread holder from the NIS test gauge described in D.1. Record the peak disassembly torque (twist down).

F.3.3.2 Repeat the above steps (from F.3.1.4) with the new needle for the second target dose of NIS. This is another dose (Vlow or Vhigh) set in a random or alternating dose order.

F.3.3.3 Repeat the above steps (starting from F.3.1.4) with the same syringe and cartridge (needle syringe with replaceable container) or needle injection device with integral non-replaceable container. Complete another required parallel test.

F.4 Acceptance criteria