GB/T 16886.11-2021 adds tests for subchronic systemic toxicity evaluation with dual-route exposure. Which products are suitable for dual-route exposure, and can dual-route exposure methods represent subchronic toxicity under polar and non-polar extraction conditions?

According to current standards, dual-route exposure is suitable for non-implantable devices (e.g., vascular stents) and external contact devices (contacting blood, liquid path devices).

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GB/T 16886.11-2021 Adds Tests For Subchronic Systemic Toxicity Evaluation With Dual-route Exposure. Which Products Are Suitable For Dual-route Exposure, And Can Dual-route Exposure Methods Represent Subchronic Toxicity Under Polar And Non-polar Extraction Conditions?

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