ISO/NP TS 24830

Application of in-silico/read-across approaches for identifying a medical device constituent analogue

Апстракт

This document specifies the process and provide guidance on how to justify and document the selection of appropriate read-across analogues to support the estimation of a point-of-departure (POD) in context of normative requirements in .This document also defines common terms used for read-across analysis.The document is applicable to describe the process required to support any toxicological risk assessment for which a relevant POD is missing.The document does not apply to selection of specific algorithms and computational tools.
The process described in this document applies, and does not apply, to the same information or circumstances described in Clause 1 in ISO 10993-17.