Creamedix GmbH

Königsberger Strasse 2 | 76356 Weingarten - Germany

Tel:  +49 7244 60 82 65 | Fax: +49 7244 60 82 69

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Akkreditiertes Prüflabor für Biokompatibilitätstests

Biological Testing Services

Tests accrording to ISO 10993

 
 
 
 
 
 

genotoxicity, carcinogenicity and reproductive toxicity

DIN EN ISO

10993-3

These tests are performed to evaluate the mutagenic potential (genotoxicity) of your medical devices/materials, the potential of your products to cause cancer (carcinogenicity) and/or to act teratogenic.

 

  • Genotoxicity

    • In vitro-test (Ames-test)

      Test duration: 2 weeks

 

  • Carcinogenicity

    • In vivo-tests with adequate animal models according to the OECD test guideline 451

      Test duration: 6-12 months

 

  • Reproductive toxicity

    • In vivo-tests with adequate animal models

      Test duration: 2-3 months

Selection of tests for interaction with blood

DIN EN ISO

10993 - 4

These tests are performed to evaluate the potential of your product to activate the clotting system, the complement system and to induce adverse effects on blood cells. In order to assess these multifold possibilities of blood-medical device-interaction different test categories are defined by the respective DIN EN ISO norm (thrombosis, coagulation, thrombocytes, hematology, and complement system). In vitro-tests in dynamic systems and in vivo-tests with adequate animal models.

 

  • Effects of medical devices on blood cells (in vitro):

    • Test parameter:
      Number of leucocytes
      Number of platelets
      Hemolysis

 

  • Effects of medical devices onblood coagulation:

    • in vitro-test parameter: Prothrombin time, Thrombine time, Fibrinogen Plateletfactor PF-4

    • in vivo-test parameter:Thrombus formation

 

  • Effects of medical devices on the complement system (in vitro):

    • Test parameter:  Complement factor C5a

 

 

Test duration: 1 week (in vitro-tests) up to 4 months (in vivo-tests)

In vitro-cytotoxicity

DIN EN ISO

10993-5

In vitro-tests with extracts of your medical devices.To evaluate possible toxic effects of your medical devices onto mammal cells test are performed to analyze cell viability, cell membraneintegrity, cell proliferation and cell activity.

 

  • Influence on cellviability:

    • Test parameter: cell viability, Cell/ cell-layer phenotyp

 

  • Influence on cell membrane integrity:

    • Test parameter: Lactate dehydrogenase (LDH)-release

 

  • Influence on cell proliferation:

    • Test parameter: Changes of the cell number

 

  • Influence on cell activity:

    • Test parameter: Activity of cellular dehydrogenases

 

Test duration: 1 week

Local effects after implantation

DIN EN ISO

10993-6

This test is performed to evaluate the tissuereaction to your medical device after implantation and also to assess the degradation behavior of your product.

 

This test (in vivo-test with adequate animal models) is however not intended or able to evaluate mechanical and functional characteristics of your product.

 

Test duration: 3-4 months

Irritation and sensitization

DIN EN ISO

10993-10

These tests are performed to assess potential skin irritation and allergic sensitization after contact of your medical device with the skin.

 

  • Skin irritation:

    • In vitro-test with recultivated human skin (epidermis) according to OECD test guideline 439

      Test duration: 2 weeks

  • Skin sensitisation

    • In-vitro skin sensitisation KeratinoSensTM according to OECD 442D

 

  • Allergic sensitization:

    • In vivo-test with guinea pigs (guinea pig maximisation test, GPMT-Test) according to OECD test guideline 442B

      Test duration: 1-2 months

Systemic toxicity

DIN EN ISO

10993-11

These tests are performed to assess possible toxic effects of your medical devices in the organism.Depending on the characteristics of your medical devices different test durations are necessary:

 

  • Acute systemic toxicity (toxie influence within 24 hrs)

    • 4 - 5 months

 

  • Subacute systemic toxicity (toxie influence within 24 hrs to max. 28 days)

    • 5 - 6 months

 

  • Subchronic systemic toxicity (toxie influence within max. 90 days)

    • 7 - 8 months

 

  • Chronic systemic toxicity (toxie influence within 6 - 12 month)

    • 11 - 17 months

 

In vivo-Tests with adequate small animal models

Endotoxin-mediated pyrogenicity 

USP 40-NF35:2017

Endotoxins are part of the cell membrane from Gram-negative bacteria and are one of the most potent pyrogens. The endotoxin test (in vitro Limulus amoebocyte lysate-test) is performed to measure to endotoxin load of your medical devices, which has to be below a certain level.

 

Test duration: 1 week