CE Mark & ISO Certificates


INTERCEPT Blood System CE Mark

The INTERCEPT Blood System is registered in Europe as a Class III medical device. The Platelet system received CE Mark in 2002, followed by CE Mark for the Plasma system in 2006.

Blood products treated with the INTERCEPT Blood System have also received regulatory approvals in France (AFSSAPS), Germany (PEI), and Switzerland (Swissmedic).

pdf Platelet CE Mark Certificate »
pdf Plasma CE Mark Certificate »

The INTERCEPT Illuminator is a Class I accessory to the INTERCEPT Blood System and is CE Marked according to Annex VII, EC Declaration of Conformity.

pdf Illuminator Declaration of Conformity »

Cerus ISO Certificates

The INTERCEPT Blood System for Platelets and Plasma are produced to the ISO 13485:2003 quality standard as certified by TÜV SÜD. At Cerus we are committed to continual improvement of our quality management system.

pdf ISO 13485 Quality Management System Certificate »