In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
This document is available in electronic format only.
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Date of Publication: May 1, 2019
Order Code PDF: ISO20916E
Order Code Print: print not available
ISO 20916:2019 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.