We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices. Check out!
We offer pre-clinical testing and consulting services of medical devices. We have our own laboratories that are among some of the most modern in all of Europe and we are proud to say we have a very broad field of tests we are able to conduct. We are not exaggerating by saying that to us nothing is impossible! We always advise our customers good and cost-effective solutions.
Biocompatibility of medical devices has to be evaluated in the view of the ISO 10993 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. The biological test methods applicable for respective medical devices are classified in regard to their nature and duration of contact.
The list of medical device tests that we conduct on site:
Biocompatibility
Cytotoxicity ISO 10993-5
MEM Elution
Direct contact
Agar diffusion
Filter diffusion
MTT/XTT
Neutral Red Uptake
Sensitization ISO 10993-10
Guinea pig maximization test (GPMT, Magnus-Kligman Maximization)
Closed-patch (Buehler)
Murine Local Lymph Node Assay (LLNA)
Irritation or Intracutaneous reactivity ISO 10993-10, ISO 10993-23 additionally:
Ocular irritation
Oral mucosa irritation
Penile irritation
Rectal irritation
Vaginal irritation
In vitro irritation
Material mediated pyrogenicity ISO 10993-11
Endotoxin LAL
Rabbit pyrogen test
Acute systemic toxicity ISO 10993-11
Subacute toxicity ISO 10993-11
Subchronic toxicity ISO 10993-11
Chronic toxicity ISO 10993-11
Implantation ISO 10993-6
Subcutaneous
muscle
bone
brain
relevant clinical site
Hemocompatibility ISO 10993-4
Hemolysis
Coagulation
Platelet activation
Complement
Hematology
Genotoxicity ISO 10993-3, ISO 10993-33
Bacterial reverse mutation assay (AMES)
Mouse Lymphoma Assay (MLA)
Carcinogenicity ISO 10993-3
Reproductive/developmental toxicity ISO 10993-3
Degradation ISO 10993-13, ISO 10993-14, ISO 10993-15, ISO 10993-16
Immunotoxicology ISO 10993-20
Nanomaterials ISO 10993-22
Chemistry (Extractables and leachables)
Physical and/or chemical information ISO 10993-18
Headspace GC-MS
GC-MS
LC-MS
ICP-MS
FTIR
UV/VIS SpectroscopyUSP <197>
Toxicological risk assessment ISO 10993-17
Microbiology and sterility testing (ISO 11737-1, ISO 11737-2)
Automated cleaning ISO 17664, ISO 15883-1, ISO 15883-5, ASTM 2314, ISO 7864, ISO 10993-5
Manual cleaning ISO 17664, ASTM 2314, ISO 7864, ISO 10993-5
Disinfection ISO 17664, ASTM 1837, ISO 10993-5
Steam sterilization ISO 14937, ISO 17665-1
Consulting services of medical devices
Biological Evaluation Plan (BEP)
Biological Evaluation Report (BER)
Risk analysis
Clinical evaluation
Instruction for Use
Certification strategy
We have our own animal facility and in vitro laboratories that are GLP-certified for testing mentioned above.
If you need any test for you medical device, just let us know – we will help you on your way!
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