Cytotoxicity
ISO 10993-5
Cytotoxicity (ISO 10993-5) assesses the potential of a medical device material or extract to cause cell damage or death through in vitro cell culture testing.
GET A QUOTETEST SUBCONTRACTING
Groenakker offers a full suite of in vitro and in vivo services through qualified partners. We routinely assist clients by leveraging our global testing network to provide high-quality testing at industry-leading prices and turn around times. The most common studies which we support are available within the Shop, though through our partners we have access to the full compliment of biocompatibility tests associated with ISO 10993 and ISO 18562.
CREATE A QUOTEMedical Device Biocompatibility Testing Services
Groenakker’s biocompatibility test subcontracting gives medical device manufacturers a single point of contact for the entire ISO 10993 test battery— cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and more — executed through a vetted global network of accredited laboratories.
We select the right lab, write and manage the protocols, schedule the work, and review the data, so you get high-quality biocompatibility testing at industry-leading price and turnaround without managing multiple vendors. In vitro and in vivo studies are available under both ISO 10993 and ISO 18562 for respiratory devices.
HOW IT WORKS
Phase IPlanning & Review
01 - Initial Meeting — Understand Device(s) and agree to scope of project. Client issues Purchase Order.
02 - Submit samples to Groenakker for review.
Phase IITesting
Estimated TAT: Based on Test03 - Groenakker reviews samples & completes sample submission form for client review.
04 - Testing is performed at ISO 17025 accredited laboratory per Groenakker-approved protocols.
Phase IIIData Analysis & Review
Estimated TAT: 2 Days05 - Review of draft test reports for accuracy & conformity to test requirements.
06 - Report correction & finalization.
Phase IVReporting
Estimated TAT: 1 Week07 - Final approved reporting of results to Client.
TEST SOURCING
ISO 13485:2016 Quality Management System
We identify, qualify, and manage competent laboratory service providers so you don't have to.
Groenakker partners with ISO 17025 laboratory testing partners around the world to provide the best services at competitive prices and turnaround times. Along with chemistry and toxicology services provided through our ChemTox™ program, routinely subcontracted studies are listed below. If you do not see what you're looking for contact us today for a custom estimate.
Sensitization
ISO 10993-10
Sensitization (ISO 10993-10) evaluates the potential of a medical device or its materials to induce an allergic response following exposure.
GET A QUOTEIrritation
ISO 10993-23
Irritation (ISO 10993-23) assesses the potential of medical device materials to cause local inflammatory responses or irritation upon contact with the body.
GET A QUOTESystemic Toxicity
ISO 10993-11
Systemic Toxicity (ISO 10993-11) examines the potential for systemic adverse effects resulting from exposure to medical device materials or their extracts throughout the body.
GET A QUOTEHaemocompatibility
ISO 10993-4
Haemocompatibility (ISO 10993-4) evaluates the interactions between medical device materials and blood to identify risks such as thrombosis, hemolysis, or adverse effects on blood components.
GET A QUOTEImplantation
ISO 10993-6
Implantation (ISO 10993-6) evaluates the local biological response of living tissues to medical device materials following implantation.
GET A QUOTETEST SUBCONTRACTING FAQ
What is biocompatibility test subcontracting?
Biocompatibility test subcontracting is a managed service in which Groenakker coordinates a medical device's testing on your behalf — selecting accredited laboratories, writing and managing protocols, scheduling the work, and reviewing results — so you work with one partner instead of many labs.
Which biocompatibility tests can you coordinate?
The full ISO 10993 battery, including cytotoxicity, sensitization, irritation and intracutaneous reactivity, acute and subchronic systemic toxicity, genotoxicity, implantation, and hemocompatibility — plus ISO 18562 testing for gas-pathway (respiratory) devices.
Do you run the tests in your own laboratory?
We coordinate testing through a qualified global network of ISO 17025-accredited laboratories, matching each study to the best-suited lab. That gives you broad capability, competitive pricing, and managed turnaround without vendor sprawl.
How do you keep testing fast and cost-effective?
A biological evaluation and gap assessment come first so only necessary tests are run. We then leverage our laboratory network and manage protocols and scheduling end to end to compress timelines.
Which standards does the testing follow?
Testing is planned and executed to ISO 10993 (and ISO 18562 for respiratory devices), aligned with the FDA's biocompatibility guidance and EU MDR expectations.
GROENAKKER WORKS CLOSELY WITH OUR CLIENTS TO CREATE BESPOKE BIOLOGICAL SAFETY EVALUATIONS. WHATEVER BIOCOMPATIBILITY NEEDS YOU HAVE, WE HAVE THE SOLUTION AND EXPERTISE TO DRIVE SUCCESS.
CREATE A QUOTE TODAY