Hello All, I am seeking opinions concerning the Class A or Class B emissions for an in-vitro diagnostic system to be CE marked. The system is used for the calculation of human blood volume from a small sample of plasma collected into a counting vial. The system will be installed in medical laboratories that may be in a hospital, medical clinic, etc.
It is definitely not for use in households. If the product is labeled Class A, is there any disclaimers appropriate in the labeling? Class A Equipment: Equipment suitable for use in establishments other than domestic, and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. Class B Equipment: Equipment for use in domestic establishments, and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. It depends upon where such labs are typically located in Europe. Your opinions would be most appreciated. Best Regards, Pryor McGinnis [email protected] www.ctl-lab.com
