Pump Performance Test
The pump performance will be evaluated against design specifications.
Test Procedure
The pump flow rate and inlet and outlet pressure will be measured across the range of conditions listed in the IFU. A temperature controlled flow loop with a blood analogue will be used as a test fluid.
Service Levels
Applicable Standards
-
ISO 14708-5:2020
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Related Tests
OLE/QV
ViVitro Labs Advantages
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
ISO 17025 Accredited
For studies used for regulatory approval this is a must.
Victoria and
Marseille labs accredited by A2LA.
Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation.
ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited.
We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.
Timeliness
We understand how critical your timelines are.
Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.
中国地区询价
1 (250) 388-3531
+33 4 86 68 68 10