The administrative counterpart may develop the requirements for the hardness of components and cutting knives according to the clinical needs that the performance of the product should meet, and provide the basis for determining the hardness requirements as well as corresponding verification data. The requirements in the “Guidelines for the Technical Review of the Registration of Stapler Products”can be adopted, i.e., the components made of 20Cr13 material should be heat treated, with a hardness of 40HRC- 48HRC. The hardness of the cutting knives should not be less than 377HV0.2.
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