In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice

ISO 20916:2019

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.

 

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Publication Details

Date of Publication: May 1, 2019

Order Code PDF: ISO20916E

Order Code Print: print not available

Edition: First

Pages: 56

ISO 20916:2019 Additional Details

Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.