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Get a 20% discount on BS EN ISO 20916

By June 11, 2024No Comments


BSI has recently launched BS EN ISO 20916. The standard defines good practice for clinical performance studies of IVD medical devices.

BIVDA members can get a 20% discount on this standard by entering SHOBVIDA20 at the checkout.

BS EN ISO 20916

It’s critical that clinical performance studies consistently produce data of the highest quality so that safe healthcare decisions can be made.

To that end, BS EN ISO 20916:2024 is the latest international standard defining what global good practice looks like in the planning, design, conduction and reporting of clinical performance studies.

The document:

  • Identifies the principles that underpin performance studies
  • Defines the responsibilities of principal investigators and sponsors
  • Assists you with ethical considerations and clinical performance study planning
  • Gives guidance on the proper collection and evaluation of specimens, including recording of specimen information, specimen accountability and specimen integrity
  • Details close-out for clinical performance studies using specimens from human subjects
  • Covers requirements for various situations where IVD medical devices may be used

The standard is for:

  • Manufacturers of In vitro diagnostic medical devices
  • In vitro diagnostic clinics
  • Test centers for In vitro diagnostic medical devices
  • Regulatory authorities and others.
  • Clinical research organizations
  • Investigators
  • Sponsors



Ben Kemp