Standards Development
Clause 6.9 of ISO/FDIS 10993-1:2025 notes that biological risk estimation is an input to determine biological safety and requires that, for each biologically hazardous situation, the manufacturer shall estimate the associated biological risk(s), taking the level of uncertainty inherent in the risk analysis into account. The biological evaluation process established by ISO 10993-1 is itself a risk management process, aligned with the overall principles of ISO 14971.
This document will provide guidance on the conduct of biological risk estimation of medical devices, within the framework established by the ISO 10993 Series of Standards.
It is acknowledged that the recently-approved ISO/FDIS 10993-1:2025 introduces requirements for which guidance is not yet provided. One such area is that of biological risk estimation, which is a critical step when considering biological evaluation within the framework of risk management.
At the inaugural meeting of the ISO/TC 194 Strategic Advisory Group (SAG) on 15th May 2025, it was agreed that guidance on biological risk estimation should be prepared by the TC as a high priority. To support this, an 8-week ballot for this NWIP was agreed by ballot of the NSBs.
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