Scope of application: it is used for puncture of human abdominal wall tissue during laparoscopy and operation to establish the working channel of abdominal surgery.
1.1 specification and model
The specifications and models of disposable laparoscopic puncture device are divided into four types: type A, type B, type C and type D according to the size of puncture sleeve and the structural form of puncture cone, as shown in Table 1; According to the packaging method, it is divided into single package and suit.
Table 1 specification and model of disposable laparoscopic puncture device unit: mm
1.2 specification and model division description
1.3 product composition
1.3.1 product structure
The disposable puncture device for laparoscopy is composed of puncture cone, puncture sleeve, gas injection valve, choke valve, sealing cap, sealing ring, etc. The option is a converter. The structure diagram of the product is shown in Figure 1.
1. Puncture cone 2 Puncture cannula 3 Gas injection valve 4 Choke 5 Sealing cap 6 Sealing ring 7 converter
1.3.2 material composition of main parts of the product
The material composition of the main parts of the disposable laparoscopic puncture device of this product is shown in Table 2 below:
2.1 dimensions
The size of the product shall comply with the provisions in Table 1.
2.2 appearance
The product surface shall be flat and smooth without burrs, pores, cracks, grooves and sinters that can be identified by the naked eye.
2.3 flexibility
The gas injection valve and choke valve of the puncture device shall be opened and closed flexibly without blocking or jamming.
2.4 coordination performance
2.4.1 the fit between the puncture sleeve and the puncture cone shall be good, and there shall be no jamming during interaction.
2.4.2 the maximum fit clearance between the puncture sleeve and the puncture cone shall not be greater than 0.3mm.
2.4.3 when the puncture sleeve is matched with the puncture cone, the head end of the puncture cone must be completely exposed.
2.5 # tightness and gas resistance
2.5.1 the gas injection valve and sealing cap of the puncture device shall have good sealing performance, and there shall be no leakage after passing the air pressure of 4kPa.
2.5.2 ￠ the choke valve of the puncture device shall have good gas blocking performance. After 4kPa air pressure, the number of bubbles shall be less than 20.
2.5.3 the converter shall have good sealing, and there shall be no leakage after passing 4kPa air pressure.
2.6 ethylene oxide residue
The product is sterilized with ethylene oxide, and the residual amount of ethylene oxide shall not be greater than 10 µ g / g before leaving the factory.
2.7 sterility
The product should be sterile.
2.8 pH
The pH value difference between the product test solution and the blank solution shall not exceed 1.5.
2.9 total content of heavy metals
The total content of heavy metals in the product inspection solution shall not exceed 10% μ g/ml。
2.10 evaporation residue
The evaporation residue per 50ml of product test solution shall not be greater than 5mg.
2.11 reducing substances (easily oxidized)
The volume difference of potassium permanganate solution [C (KMnO4) = 0.002mol/l] consumed by product test solution and blank solution shall not exceed 3.0ml.
2.12 UV absorbance
The absorption value of the product test solution in the wavelength range of 220nm ~ 340nm shall not exceed 0.4.000000000000000000000000
Post time: Apr-13-2022
