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GLP Test Laboratuvarları

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Cell Culture Laboratory

Sia Analiz Laboratuvarları > Medical Device > Cell Culture Laboratory

Cell Culture Laboratory

Sia Analiz Laboratuvarları

Sia Analiz Laboratuvarları

Hücre Kültürü Laboratuvarı

Sia Analiz

Hücre Kültürü Laboratuvarı

According to the Medical Device Regulation published in the Official Gazette dated 07.06.2011 and numbered 27957, Medical devices, when used in humans, do not provide their main function with pharmacological, immunological, or metabolic effects, but can be supported by these effects while fulfilling their function and are manufactured for use on humans for;

1) Diagnosis, prevention, monitoring, treatment, or alleviation of disease

2) Monitoring, treatment, alleviation, or redress of injury or disability

3) Investigation, modification, or replacement of an anatomical or physiological function

4) Birth control

purposes, alone or together. It has been manufactured by the manufacturer specifically for diagnostic and/or therapeutic use. It is defined as any tool, instrument, equipment, software, accessory, or other material, including software, necessary for the medical device to perform its intended function.

In our laboratory, the biocompatibility tests required for the CE certificate or license of Medical Devices are carried out within the scope of OECD GLP.

The tests performed in our laboratory with GLP approval are as follows;

  • Chemical Characterization Tests
  • Detection and Determination of Degradation Products
  • Determination of Ethylene Oxide Residue
  • Product Stability
  • Particle Size
  • Raw Material Purity
  • Extractable & Leachable
  • Toxicological Risk Assessment
  • Cytotoxicity
  • Hemocompatibility
  • Systemic Toxicity
  • Genotoxicity
  • Sensitivity Tests
  • Irritation Tests
  • Subchronic Systemic Toxicity
  • Chronic Systemic Toxicity
  • Ames Test
  • Comet Test
  • Pyrogenicity Test
  • LD 50 Dose Determination Test
  • Irritation Test
  • Micronucleus Test

Please contact us for more information about the tests we do on Medical Devices.