Inside Medical Technology

11 - 12 April 2018 // Nuremberg, Germany

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Exhibitors & Products MT-CONNECT 2017
Zoom product LOGO_Biological evaluation of medical devices

Biological evaluation of medical devices

LOGO_Biological evaluation of medical devices

Biological evaluation of medical devices

Testing of materials, surfaces and functional biomaterials

Tests with mammalian cells

In vitro cytotoxicity
Incubation of cultured cells in contact with a device and/or extracts of a device.

Evaluation: According to DIN EN ISO 10993-5, Cell death, Inhibition of cell growth, Cell proliferation
Additional Methods: Cell adhesion, Inflammatory effects, Drug release / delivery / function, Further client specific functional assays
are available on request

Tests with blood

In vitro hemocompatibility
Accreditation based on DIN EN ISO/IEC 17025

Testing of medical devices for interactions with blood

Test performance: Static or dynamic blood incubation
Evaluation: According to DIN EN ISO 10993-4, Coagulation, Platelets, Hematology, Complement, Thrombogenicity

Tests for microorganisms

Antibacterial activity
Antibacterial activity on plastics and other non-porous surfaces. According to DIN EN ISO 22196
Antibacterial activity on textile products. According to DIN EN ISO 20743

Pyrogenicity
Accreditation based on DIN EN ISO/IEC 17025
Pyrogenicity of parenterally applied drugs and medical devices.
Evaluation:
Monocyte Activation Test (MAT) for pyrogens, Limulus Amoebocyte Lysate (LAL) assay for endotoxins

Design and development services

LOGO_Design and development services

Biological evaluation of medical devices is assigned to following product groups:

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