Biological evaluation of medical devices; part 1: guidance on selection of tests; technical corrigendum 1

This document represents a technical correction issued by the International Organization for Standardization regarding its foundational guidance on the biological evaluation of medical devices. It specifically addresses the first part of the standard series, which provides a framework for selecting appropriate testing methods to assess biocompatibility. The revision clarifies and rectifies certain provisions within the original guidance to ensure greater precision and consistency in the selection of testing protocols. By issuing this amendment, the organization aims to refine the understanding of how manufacturers and evaluators should approach the assessment of potential biological risks associated with medical products. This update serves to eliminate ambiguities present in the initial version, thereby supporting more accurate and reliable evaluation practices across the industry. The content focuses exclusively on the procedural guidance for choosing suitable tests, emphasizing the systematic approach required for evaluating biological interactions. It acts as an essential reference for aligning current practices with the corrected requirements, ensuring that the selection process remains robust and scientifically sound without altering the core principles established in the primary document.