What Are The Principles For Establishing Acceptance Criteria For Ethylene Oxide Residuals In Products Such As Suture Anchor, Titanium Plate With Loop?


2022-10-30

If suture anchor, titanium plate with loop etc. are sterilized with ethylene oxide, acceptance criteria for ethylene oxide residuals should be established. The intended use and structure & composition of the product should be combined to fully consider the effect of ethylene oxide residuals on safety and effectiveness of product. Refer to GB/T 16886.7, to explain the process of establishing the acceptance criteria.