Question 1

How often is ISO 10993-18 updated, and how do I stay current?

Accepted Answer

ISO 10993-18 was last revised in 2020, but regulatory interpretation evolves continuously based on submission outcomes, FDA feedback, and industry working group recommendations.¹,² The standard itself may not change annually, but expectations around defensibility, identification confidence, and quantification rigor shift faster than the document cycle. Partnering with a lab that sees patterns across many submissions is one of the most reliable ways to stay ahead.

Question 2

What’s the difference between meeting ISO 10993-18 requirements and having a defensible E&L program?

Accepted Answer

Meeting requirements means hitting the thresholds and deliverables the standard specifies. Defensibility means your program can withstand detailed regulatory questions about why you made specific method choices, how confident your identifications are, and whether your quantification approach accounts for response factor variability. The programs that hold up document their rationale, justify method selection based on device chemistry, and go beyond minimum expectations where risk warrants it.

Question 3

When should I use predictive modeling instead of empirical standards for quantification?

Accepted Answer

Predictive modeling is not limited to situations where empirical standards are unavailable. Applying predictions across all compounds in a study is still a stronger approach than traditional methods, even where some empirical standards could theoretically be obtained. This is because the practical constraints of chemical complexity, synthesis challenges, and availability mean that a fully empirical approach is rarely feasible across an entire extractables profile. However, predictive models require at least tentative identification of the compound; complete unknowns still need chemist expertise to establish chemical class before modeling applies. The key is documenting when and why prediction was used and demonstrating that the approach aligns with a risk-based strategy.¹

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