YY/T 1710-2020Disposable abdominal trocars (English PDF)

3.1 Structure and Marking

3.1.2 The marking of the trocars shall at least include the following elements. See the marking below. Example of marking.

Trocars with specification code. 12; inner diameter of puncturing sleeve casing. 12.5 mm; working length of puncturing sleeve casing. 100 mm, shall be marked as. 12 x 100-12.5.

3.2 Materials

The main components of the trocars are made of the following materials.

4.1 Appearance

4.1.1 The outer surface of the trocars shall be smooth and clean. There shall be no defects, such as. burrs, bubbles, impurities, cracks and sintered substances, etc.

4.1.2 The surface of the trocars shall not have visible accumulation of lubricant.

4.1.3 The specification marking on the body of the trocars shall be clearly visible.

4.2 Dimensions

The inner diameter phi and working length L of the puncturing sleeve casing of the trocars shall comply with the stipulations of Table 1.

4.3 Surface Roughness

If there is a puncturing knife at the tip of the puncturing lever, then, the surface roughness of the cutting edge surface of the puncturing knife Ra <= 0.8 µm.

4.5 Flexibility

4.5.1 The air injection valve of the trocars shall be able to be flexibly opened and closed; there shall be no obstruction or jamming.

4.6 Coordination Performance

4.6.1 The puncturing sleeve and the puncturing lever shall properly coordinate with each other. There shall be no jamming when plugging or unplugging.

4.8 Air Chocking and Sealing Performance

4.8.1 The trocars shall have good air chocking performance. Through 4 kPa air pressure, the number of outcoming bubbles shall be less than 20.

4.8.2 The trocars shall have good sealing performance. Through 4 kPa air pressure, there shall be no leakage.

4.12 Sterility

The trocars shall be sterilized by an already confirmed sterilization process. After sterilization, the trocars shall be sterile.

4.13 Residual Ethylene Oxide

If the trocars are sterilized with ethylene oxide, the residual amount of ethylene oxide shall be not greater than 10 µg/g.

4.14.1 Appearance (turbidity and color)

The dissolution liquid shall be colorless and transparent, and there shall be no visible foreign objects.

4.14.5 Evaporation residue

The total dry residue of the dissolution liquid shall be <= 2.0 mg.

4.15 Package Marking and Instruction Manual

4.15.1 The single package of the trocars shall have a marking that complies with the stipulations of 3.1.2.

4.16 Biological Evaluation

The trocars shall receive biological evaluation in accordance with the stipulations of the series standards of GB/T 16886, and there shall be no biocompatibility hazards.

5.1 Appearance

Adopt normal or corrected vision observation and hand touching to conduct the inspection. It shall comply with the stipulations of 4.1.

5.4 Hardness

In accordance with the method specified in GB/T 4340.1, conduct the test. On the puncturing knife, test 3 points; take the arithmetic mean value. It shall comply with the stipulations of 4.4.

5.5 Flexibility Test

5.5.1 Imitate the action of use; check by hand feeling. It shall comply with the stipulations of 4.5.1 and 4.5.2.

5.6 Coordination Test

5.6.1 Imitate the action of use. Plug and unplug the puncturing lever in the puncturing sleeve for 3 times. It shall comply with the stipulations of 4.6.1.

5.6.2 Use a 0.30 mm cleansing pin to detect along the port of the casing of the puncturing sleeve for one circle, so as to observe whether the cleansing pin can be inserted into the fit clearance. It shall comply with the stipulations of 4.6.2.

5.7 Connection Firmness Test

5.7.1 At the junction of the detachable sheath cap and the puncturing sleeve, apply an axial static tensile force of 50 N to any component consecutively for 10 s. It shall comply with the stipulations of 4.7.1.

5.8 Air Chocking and Sealing Performance Test

The test method is shown in Appendix A. It shall comply with the stipulations of 4.8.

5.9 Connector of Air Injection Valve

The Luer locking connecting of the air injection valve shall be tested in accordance with GB/T 1962.2. It shall comply with the stipulations of 4.9.

5.14 Test Method for Dissolved Precipitates of Polymer Materials of Parts in Contact with Patient

5.14.1 Preparation of test solution

Take the sample. In accordance with the ratio of 0.2 g of sample with 1 mL of test water (Grade-2 water that complies with the stipulations of GB/T 6682-2008), prepare it.

Then, place it in a glass container. At 37 °C ± 1 °C, conduct constant-temperature extraction for 24 h. Separate the sample and the liquid; cool it down to room temperature; use it as the test solution.

Take the same volume of test water, place it in a glass container. Use the same method to prepare the blank control solution.

5.15 Package Marking and Instruction Manual

Conduct visual observation. It shall comply with the stipulations of 4.15.

5.16 Biological Evaluation

The trocars shall receive biological evaluation in accordance with the stipulations of the series standards of GB/T 16886. It shall comply with the stipulations of 4.16.

7.1 Labeling

The labeling of the trocars shall at least have the following contents or symbols.

7.2 Instruction Manual

The instruction manual of the trocars shall at least include the following contents.