Your Partner for Preclinical Medical Devices Testing
Medical devices are assessed for biocompatibility as detailed in ISO10993. This is the accepted international standard which is used in conjunction with national requirements such as the United States Pharmacopeia (paragraphs 87 and 88). Citoxlab and AccelLAB have extensive experience of the biological testing necessary to comply with these standards.
The range of medical devices is very diverse, and we have successfully tested devices made from polymer, metal, ceramic and biodegradable materials. The forms of devices we have tested include solids and porous scaffolds, creams, gels, liquids, fabrics, cements, coatings and surface treatments.
Part 6 of the ISO10993 standard describe the intramuscular implantation of the device. In some cases, the native device can also be implanted in its intended location in an adapted version of ISO10993 Part 6. AccelLAB has developed an world expertise in the preclinical evaluation of cardiovascular (stent, scaffold, valves, occluders) and orthopedic devices (screws, plates, cement and cages). In support to medical device evaluation is top of the line imaging technologies for both in vivo (fluoroscopy, CT-Scan, ultrasound, MRI, x-ray, IVUS and OCT) and ex vivo (micro-CT & faxitron). Also available is specialized grinding histopathology to cut through metallic, polymeric and ceramic implants and bone
Specific testing is recommended in the standards for each particular type of device and we offer the full range of required in vitro and in vivo biological tests. Whether you require testing of a finished device or assessment of raw plastic materials (USP Class I to VI) we can offer you the necessary packages.
The main current studies are listed below and we are always happy to discuss new projects.
In vitro cytotoxicity
- Qualitative version with L929 cells that complies with both ISO10993-5 and USP (paragraph 87)
- Local lymph node assay (LLNA)
- Guinea pig maximization test (GPMT)
- Topical irritation (skin, buccal cavity, vagina, urethra, rectum)
- Intracutaneous reactivity
- Single or cumulative exposure in accordance with the intended clinical use
- Ames test (OECD 471)
- Gene mutation test in mouse lymphoma cells (OECD 476)
- Mouse micronucleus test (OECD 474) – for submissions to the US FDA
- Acute and repeated exposure, available with a wide range of dose routes in appropriate species
- Muscular or subcutaneous implantation in rabbits
- Cardiovascular stents, scaffolds and drug-coated balloons in swines
- Structural heart devices: cardiac valves, occluders in pigs
- Electrophysiology: Pacemakers and leads in dogs
- Orthopedic implants
- Long bone defects & osseointegration in sheep
- Spinal fusion models
- Joint & cartilage repair models
- Dental implants and craniomaxillofacial defects models
- Subcutaneous implantation in rats
- In vitro hemolysis
- In vitro coagulation
Carcinogenicity and reproductive toxicity
- It is extremely rare that these test types are performed for medical devices. Our experience with these study types, when testing pharmaceuticals, enables us to perform them with medical devices if necessary.
- The efficacy of certain types of medical devices can be assessed, for example in cardiovascular, orthopaedics and wound healing studies. Please contact us to discuss your requirements.