What is BS EN ISO 20916 – In vitro clinical performance studies about?
To help with regulatory compliance, robust results and ethical considerations, BS EN ISO 20916:2024 is a stand-alone international standard that defines good practice for clinical performance studies of IVD medical devices when specimens from human subjects are used.
Who is BS EN ISO 20916 – In vitro clinical performance studies for?
Manufacturers of in vitro diagnostic medical devices
In vitro diagnostic clinics
Test centres for in vitro diagnostic medical devices
Regulatory authorities
Clinical research organizations
Investigators
Sponsors
What does BS EN ISO 20916 – In vitro clinical performance studies cover?
It defines good study practice for the planning, design, conduction, recording and reporting of clinical performance studies. These studies are carried out to assess the clinical performance and safety of in vitro diagnostic medical devices (IVD) for regulatory purposes.
BS EN ISO 20916:2024 identifies the principles that underpin clinical performance studies and specifies general requirements.
Why should you use BS EN ISO 20916 – In vitro clinical performance studies ?
It helps produce robust results. The standard helps ensure that clinical perfo...
Open preview (PDF)In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice