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#Industry News

Stapler Research Requirements

Research on Sterilization Process of Stapler

(1) The sterilization process (methods and parameters) and its selection basis and sterility assurance level (SAL) should be clarified, and a sterilization confirmation report should be provided. The sterility assurance level (SAL) of the stapler should reach 1×10-6.

(2) For reusable staplers, the recommended sterilization process (methods and parameters) and the basis for the determination of the recommended sterilization method should be clarified, and research data on the resistance of the device to the recommended sterilization method should be provided.

(3) Residual toxicity: If the sterilization method is prone to residues, such as ethylene oxide sterilization, the residue information and treatment methods should be clarified, and research materials should be provided.

Details

  • Changzhou, Jiangsu, China
  • XNY Medical Technology