Request for renewal: Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation (Annex IV n. 42)

This exemption relates to intravascular ultrasound imaging systems (IVUS), which is an imaging procedure that provides in vivo visualisation of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall. Mercurybased slip rings provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The previous evaluation concluded that elimination or substitution of mercury in IVUS devices using rotational transducers and operating at frequencies above 45 MHz is impractical. It was also understood that IVUS systems operating at 60 MHz have a number of significant advantages over other IVUS devices available on the market operating at lower frequencies, which do not require the use of the mercury containing rings.

 

Documents of Applicant

> Original exemption request (ACIST Medical Systems)

Results from previous evaluations

> Excerpt 1 (PDF)

Questionnaire

> Consult Questionnaire (PDF)

 

Contributions to the consultation 

Will be updated