What are the principles for establishing acceptance criteria for ethylene oxide residuals in products such as suture anchor, titanium plate with loop?

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.

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

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