GE Healthcare

Venue 50 -Ethiopia

6.3.5.1 Biocompatibility
The materials used in the probes which are used together with Venue 50 have direct contact with
the patient. Appropriate biocompatibility testing is completed for these materials which are
patient contacting (direct). This is per the applicable ISO 10993 standard.
6.3.5.2 Medicinal substances
This is not applicable. Venue 50 system does not incorporate medicinal substances.
6.3.5.3 Biological safety
This is not applicable. Venue 50 system does not contain animal or human origin materials.
6.3.5.4 Sterilization
This is not applicable. Venue 50 system is not provided sterile.
6.3.5.5 Software verification and validation
Verification and validation testing was completed per Design Controls. The testing was traceable
to the corresponding product specification requirements and user requirements. See attached
software verification report:
Venue 50 Software Verification Report DOC1450901.
6.3.5.6 Animal studies
This is not applicable. Venue 50 program did not conduct any animal studies
for its development.