Request for revocation: Lead in single crystal piezoelectric materials for ultrasonic transducers (Annex IV n. 14)

This exemption covers transducers used in medical ultrasound imaging. Medical ultrasound imaging is used to produce images of the interior of the human body. It is also used in minor surgery, for example to guide hypodermic needles to the required sites. The previous evaluation concluded that substitution or elimination of lead for this application is not yet scientifically and technically practical. However, it was also found that there were promising new technologies based on cMUT ( capacitative micromachined ultrasonic transducers) and pMUT (piezoelectric micromachined ultrasonic transducers). Therefore, the latest evaluation also recommended to prolong the exemption for only four years, instead of seven years as requested by the applicant.

 

Documents of Applicant

> Original exemption request (Butterfly Network, Inc.)


Results from previous evaluations

> Excerpt 1 (PDF)

Questionnaire

> Consult Questionnaire (PDF)

> Millicent Questionnaire (PDF)

 

Contributions to the consultation 

> Contribution of Bandelin: PDF

> Contribution of Butterfly: Additional information to the revocation request; study on the Butterfly iQ3: PDF

> Contribution of COCIR: PDF

   >> Additional information: Analysis of the Butterfly information

> Contribution of Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM) in English: PDF

   >> in German: PDF

   >> Annex 1: PDF

   >> Annex 3: PDF

   >> Annex 5: PDF

   >> Annex 6: PDF

   >> Annex 7: PDF

> Contribution of EFSUMB/ESR: PDF

> Contribution of GE HealthCare: PDF

> Contribution of JBC: PDF

> Contribution of MedTech Europe: PDF

> Contribution of Millicent: PDF 

   >> Additional information: PDF

> Contribution of Okmetic: PDF

> Contribution of PI-Ceramic: PDF

> Contribution of RomeTreUniversity: PDF

> Contribution of Stanford: PDF

> Contribution of TU Dresden: PDF

> Contribution of ZVEI: PDF

  >> Annex 2: PDF

  >> Annex 3: PDF