YY/T 1698-2020Medical devices for human assisted reproductive technology in vitro—Assisted reproduction aspiration needles (English PDF)

3.1 Puncture and egg retrieval needle

In the process of in vitro fertilization-embryo transfer and its derivative technology, it is used to puncture follicles in the ovary to obtain oocytes. instrument.

4.1 Specifications

The manufacturer shall describe in detail the specifications and models of each product in the same registration unit, generally divided into single-chamber, double-chamber and two-section tube types. Single cavity take The egg needle is composed of a puncture needle, a puncture needle protective cover, a handle, a suction catheter, a catheter sleeve, a silicone plug, a vacuum catheter and an inner conical connector. Of which double cavity The egg retrieval needle also includes a flushing catheter. The two-section tube type egg retrieval needle is different in the main puncture needle, which is divided into the front section and the back section.

4.2 Product composition

The specific names of the various components of the puncture needle product are shown in Figure 1 to Figure 3, and the names and functions of the accessories are shown in Table 1. Description.

4.3 Materials

4.3.1 Raw materials

The manufacturer shall evaluate the raw materials that make up the parts of the product.

4.3.2 Containers and packaging

The safety of packaging materials should be guaranteed.

6.1 Physical properties

6.1.1 Overall

6.1.1.1 Dimensions

The manufacturer should consider what is applicable in the following dimensions.

a) Effective length of puncture needle;

b) The inner and outer diameter of the puncture needle;

c) The length of the suction catheter;

d) The length of the vacuum duct;

e) Length of irrigation catheter;

f) The thickness of the catheter wall. The manufacturer shall give the nominal size and tolerance.

6.1.1.2 Vacuum leakage

Remove the protective cover of the puncture and egg retrieval needle, connect it to the hydraulic system, and fill the system with de-bubble distilled water or deionized water at (23±2)°C.

Exhaust air, occlude the test sample, apply the negative pressure specified by the company, and keep the system stable for 120s. Keep the system under negative pressure 120s. During this period, there should be no leakage of the entire assembly (that is, the formation of one or more bubbles) and no droplets should occur.

6.1.1.3 Flow

According to GB/T 15812.1-2005 Appendix E method for testing, the amount of liquid passed in 60s is not less than 2mL.

6.1.1.4 Connection strength

The connection between the pipe and the handle, and the connection between the pipe and the conical joint should be able to withstand a 3N axial static tension without separation for 5 seconds.

6.1.2 Puncture needle

6.1.2.1 Appearance

Observed with normal or corrected vision, the outer surface of the needle tube should be smooth and free of defects.

6.1.2.2 Cleanliness

Observe with normal or corrected vision, the outer surface of the needle tube should be free of impurities produced during metal processing.

6.1.2.3 Rigidity

When testing according to GB/T 18457-2015, the deflection value of the needle tube should meet the requirements.

6.1.2.4 Toughness

When testing according to GB/T 18457-2015, the needle tube shall not be broken.

6.1.2.5 Corrosion resistance

When testing in accordance with GB/T 18457-2015 Appendix F, there should be no traces of corrosion on the part where the needle tube is immersed.

6.1.2.6 Ultrasonic detectable

The puncture needle is tested by the applicable model, and the marked position under the B-ultrasound is clearly marked.

6.1.2.7 Protective sleeve for puncture needle

Observe with normal or corrected vision. The surface should be smooth, free of black spots and impurities, and the protective cover should not fall off naturally and be easy to remove.

6.1.3 Handle

6.1.3.1 Appearance

Observe with normal or corrected vision, the surface should be smooth, free of impurities, and there should be no obvious deformation.

6.1.3.2 Positioning

The handle must have an obvious mark corresponding to the direction of the needle tip blade surface, and the mark should be clear and intuitive.

6.1.4 Piping system

Observe with normal or corrected vision. The surface should be smooth, free of black spots and impurities, and the entire pipeline should be free of creases.

6.1.5 Silicone plug

6.1.5.1 Appearance

Observed with normal or corrected vision, the surface should be smooth, free of black spots, and free of impurities, and there should be no obvious deformation.

6.1.5.2 Egg protection measures

When the oocytes enter the constant temperature test tube through the suction catheter, in order to prevent oocyte damage at the end of the suction catheter, the suction catheter should be The end or the silicone plug is equipped with egg protection measures, such as the flaring of the end of the suction catheter or the silicone plug into the test tube.

6.1.6 Within