Biological Evaluation of Medical Devices - ISO 10993

Biological Evaluation of Medical Devices According to ISO 10993
The general evaluation of the medical device covers its biological evaluations with the ISO 10993 series standards.
ISO 10993 standard series tests aim to protect people from possible risks arising from the use of medical devices.
In accordance with ISO 10093 standards, chemical characterization tests are carried out in our laboratory along with in vitro and in vivo tests.

Acute Systemic Toxicity

TS EN ISO 10993-11

Subacute Systemic Toxicity

TS EN ISO 10993-11

Intradermal Reaction

TS EN ISO 10993-10

TS EN ISO 10993-23

Eye Irritation

TS EN ISO 10993-10

Skin Sensitization

TS EN ISO 10993-10

Dermal Irritation

TS EN ISO 10993-10

TS EN ISO 10993-23

pyrogenicity

TS EN ISO 10993-11

TS EN ISO 10993-11:

European Pharmacopoeia 10.0 2.6.8

Hemolytic Effect

TS EN ISO 10993-4

carcinogenicity

TS EN ISO 10993-3

implantation

TS EN ISO 10993-6

Subchronic Systemic Toxicity

TS EN ISO 10993-11

Chronic Systemic Toxicity

TS EN ISO 10993-11

Mucosa Irritation

TS EN ISO 10993-10

MTT

TS EN ISO 10993-5

Agar Diffusion

TS EN ISO 10993-5

Filter Diffusion

TS EN ISO 10993-5

In Vitro Micronucleus Test

TS EN ISO 10993-3

Chromosomal Aberration Test

TS EN ISO 10993-3

AMES Test

TS EN ISO 10993-3