Questo sito fa uso di cookie per migliorare l’esperienza di navigazione degli utenti e per raccogliere informazioni sull’utilizzo del sito stesso. Proseguendo nella navigazione si accetta l’uso dei cookie; in caso contrario è possibile abbandonare il sito.

 

BIOCOMPATIBILITY

The tests required by ISO 10993 and USP for the evaluation of the safety of the materials used in the biomedical field are meant to highlight the potential and predictable risks associated with the human use.
The tests are chosen according to the type of medical device, its invasiveness, and the duration and type of contact with human tissue.
Biochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals.
Biochem, in addition to execution of the tests, provides a support service in the selection of tests to be performed, the method of operating specific for the device or the material to be examined, also through the drafting of Rational for choice of tests and operating protocols.
See complete list, if you do not find the test or service of your interest please contact our Sales Department.

- Cytotoxicity tests
- Mutagenicity and genotoxicity tests
- Skin Sensitization
- Skin irritation
- Mucosal irritation
- Intracutaneous reactivity
- Acute systemic toxicity
- Subacute/subchronic toxicity
- Implantation tests in different kind of tissue and sites
- Hemocompatibility: trombogenicity, coagulation tests, platelets count, hemolysis,  hematology, complement system
- Leachables investigationi as per ISO 10993-17 “Establishment of allowable limits for leachable substances”

Complete list of accredited tests: http://pa.sinal.it/PA303AR31

Here http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=dispositivi-medici  you can see the portal of the Italian Ministry of Health, where you can find information, updates, regulatory references and utility tools.

If you have not found the test or service of your interest please contact our This email address is being protected from spambots. You need JavaScript enabled to view it..