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This document specifies requirements and gives recommendations for the digitalization of slide-mounted, stained sections, processing of digital whole slide images, and artificial intelligence (AI) based image analysis to support anatomical pathology examination. This document focuses on sections from formalin-fixed paraffin-embedded (FFPE) tissues (derived e.g. from surgical resection, biopsy or autopsy). It is also applicable to paraffin-embedded tissue fixed by fixatives other than formalin.
This document is applicable to in vitro diagnostic examinations using digital pathology and AI-based image analysis performed by medical laboratories, in particular but not limited to anatomical pathology laboratories. It is also intended to be used by health institutions, in vitro diagnostics developers and manufacturers, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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This document specifies requirements and gives recommendations for the digitalization of slide-mounted, stained sections, processing of digital whole slide images, and artificial intelligence (AI) based image analysis to support anatomical pathology examination. This document focuses on sections from formalin-fixed paraffin-embedded (FFPE) tissues (derived e.g. from surgical resection, biopsy or autopsy). It is also applicable to paraffin-embedded tissue fixed by fixatives other than formalin.
This document is applicable to in vitro diagnostic examinations using digital pathology and AI-based image analysis performed by medical laboratories, in particular but not limited to anatomical pathology laboratories. It is also intended to be used by health institutions, in vitro diagnostics developers and manufacturers, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
