IN VITRO and IN VIVO biocompatibility studies of medical devices

The evaluation of the biocompatibility of a medical device is carried out in accordance with ISO 10993-1.
Table I of ISO 10993-1 classifies medical devices according to the type of contact and its duration, and lists the tests applicable to each type of biomaterial, medical device or dental device. Under the FDA (American Food and Drug Administration) additional testing may be required.

·    Cytotoxicity according to ISO 10993-5

·    Acute toxicity in Mice according to ISO 10993-11(*)             

·    Irritation in Rabbits according to ISO 10993-10(*)

·    Sensitization in Guinea Pigs according to ISO 10993-10(*)

·    Biological reactivity tests for Plastics according to  USP (United States Pharmacopoeia) classe I to classe VI)(*)  

·    Hemocompatibility in vitro (Human blood) according to ISO 10993-4

¡   Hemolysis

¡   Thrombus weight analysis

¡   Determination of PTT

¡   Activation of the complement system (CH50 and SC5b9)

·    Mutagenicity and genotoxicity according to ISO 10993-3  

¡   Reverse mutation assay on «Salmonella typhimurium his-» and «Escherichia coli»
or Ames test (OECD 471)

¡   In vitro mammalian chromosome aberration test (Human lymphocytes, CHO, V79)
(OECD 473)

¡   In vitro mammalian cell gene mutation test (L5178Y, V79, TK6)  (OECD 476, OECD 490)

¡   In vitro mammalian micronucleus test (CHO, TK6) (OECD 487)

¡   Mammalian erythrocyte micronucleus test in Rats (OECD 474)(*)

·    Implantation test in Rats according to ISO 10993-6(*)

¡   Subcutaneously or intramuscularly, (4 weeks)

¡   Subcutaneously or intramuscularly (12 weeks)

¡   Endosseus (12 weeks or 12 months or 18 months)

·    Sub-acute toxicity in Rats (4 weeks) according to ISO 10993-11 (OECD 408)(*)
possibly combined with implantation test, according to  ISO 10993-6
(according to 3R principles : Replacement - Reduction - Refinement

·    Sub-chronic toxicity in Rats (12 weeks) according to ISO 10993-11 (OECD 408)(*)
possibly combined with implantation test, according to  ISO 10993-6
(according to 3R principles : Replacement - Reduction - Refinement

·    Chronic toxicity in Rats(26 weeks, 1 year) according to ISO 10993-11 (OECD 408)(*)
possibly combined with implantation test, according to  ISO 10993-6
(according to 3R principles : Replacement - Reduction - Refinement

·    Pyrogenicity in Rabbits according to ISO 10993-11(*)

·    Micro-biological load test (Bioburden)  according to NF EN 11737-1(*)

·    Cleaning validation studies of medical devices (bacterial endotoxins, COT, hydrocarbons) according to  NF S94-091(*)

·    Sterility testing of medical device according to applicable standards

·    Biodegradation : in vitro and in vivo studies according to  ISO 10993-9 et
ISO 10993-13,-14,-15

·    Carcinogenesis in Rats according to  ISO 10993-3 (OECD 451)(*)

·    Reproductive and developmental toxicity (OECD 415, OECD 416, OECD 414, OECD 421)(*)

IN VITRO R & D on human cell cultures belonging to the implantation site of the medical device

Models

·   Osteoblasts and bone marrow osteogenic stem cells

·   Adipocytes (and stem cells)

·   Normal chondrocytes (and chondrogenic stem cells) and osteoarthritic chondrocytes

·   Endothelial cells (and stem cells)

·   Ligament fibroblasts

·   Human lens epithelial cells

·   Keratinocytes and skin fibroblasts

·   Dental pulp fibroblasts, gingival fibroblasts, gingival epithelial cells, periodontal     ligament fibroblasts, alveolar bone osteoblasts

·   Monocytes / Macrophages

·   Lymphocytes

·   Co-cultures

·   Three-dimensional cultures

·   Etc.

Studies in contact with the biomaterial

·   From adhesion to colonization (integrins, cytoskeleton, MEB)

·   Cellular proliferation

·   Cellular differentiation (extracellular matrix synthesis and specific proteins synthesis)

·   Pro-inflammatory cytokines

Screenings and adapted protocols on request

(*)Tests performed in partnership in compliance with Good Laboratory Practice

 

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