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Standards Development
This document includes guidance for determining contact duration and relevant biological harms for medical devices where bioaccumulation is expected or contact is intermittent.
This document clarifies 6.4.3.2 Intermittent contact and 6.4.3.3 Bioaccumulation in ISO 10993-1:2025 and includes processes and examples.
At the May 2025 meeting of the ISO/TC 194 Strategic Advisory Group (SAG), it was determined that an ad hoc working group should be formed to investigate this situation and report at the November 2025 meeting. The ad hoc committee proposes that a new Technical Specification should be prepared to address the evaluation and provide guidance for justification of contact duration in the context of intermittent contact and bioaccumulation.
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