CLSI 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.
This document is available in electronic format only.
Details
Date of Publication: May 1, 2019
Order Code PDF: CLSI ISO20916E
Order Code Print: print not available
Edition: First
Pages: 56
CLSI 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.