BS ISO 20916:2019
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
- Standard No.
- BS ISO 20916:2019
- Release Date
- 2019
- Published By
- British Standards Institution (BSI)
- Latest
- BS ISO 20916:2019
- Scope
- What is ISO 20916 - Clinical performance studies of In vitro diagnostic (IVD) medical devices about? ISO 20916 discusses In vitro diagnostic (IVD) medical devices. ISO 20916 is an international standard on clinical performance studies of In vitro diagnostic medical devices. ISO 20916 outlines 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. ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to: Ensure the conduct of the clinical performance study that led to reliable and robust study results Define the responsibilities of the sponsor and principal investigator Assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of In-vitro medical devices Protect the rights, safety, dignity, and well-being of...
BS ISO 20916:2019 history
- 2019 BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
