Scalpel blade sharpness tester implements standard knowledge popularization

The executive standard of the surgical blade sharpness tester is YY 0174-2019 surgical blade
.

This standard not only explains the production requirements of the surgical blade sharpness tester, Weixia Technology will take you to see the other requirements of the standard for surgical blades
.

1.
Dimensional requirements The assembly dimensions ɑ, Ṏ, b, b1, L1 and L2 of the blade, see Figure 1, should meet the requirements of GB8662
.

2.
Appearance requirements ① The value of the surface roughness Ra of the blade should be no more than 0.
4㎛, and the value of the surface roughness Ra of the cutting edge surface should be no more than 0.
8㎛
.

②The blade edge should be free of nicks, white edges, curling, cracks,
etc.

③The width of both sides of the cutting edge of the blade should be similar, and there should be no focal spots on the surface
.

④The blade should be flat, and there should be no cracks, sharp edges, burrs and obvious pitting
.

3.
The sharpness of the cutting edge The cutting edge of the blade should be sharp, and its cutting force should not be greater than 0.
8N.
4.
The hardness of the blade should be heat treated, and its hardness should not be lower than 650HV10
.

5.
The elastic blade should have good elasticity, no fracture and no obvious deformation after the test
.

6.
Anti-rust performance Open the package and test the non-sterile blade according to the sterilization or disinfection method specified in the manual.
The blade should have good anti-rust performance and there should be no rust spots on the surface
.

7.
Sterility is carried out in accordance with the general rule 1101 "sterility inspection method" of the "Pharmacopoeia of the People's Republic of China" (2015 edition, four volumes)
.

8.
The residual amount of ethylene oxide shall be carried out according to the method specified in GB/T 14233.
1.
If the blade is sterilized by ethylene oxide gas, the residual amount of ethylene oxide shall not exceed 10μg/g
.

9.
Visual observation of packaging labels and instructions, minimum packaging expressions and relevant contents of the instructions require that the packaging labels should be clear and comply with the provisions of Chapter 7; the instructions should have detailed sterilization or disinfection methods
.

The specification form and external dimension of the surgical blade, and the assembly specification of the handle, the performance test of the surgical blade is to detect the appearance, size, edge sharpness, hardness, elasticity, rust resistance, sterility, ethylene oxide of the blade according to the requirements.
residual amount,
etc.

The instruments needed to test the performance of surgical blades include surgical blade edge sharpness tester, surgical blade hardness tester, surgical blade elasticity tester, etc.
The above contents are organized by Weixia Technology, and hope to help you
.