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Medical Devices

  1. Medical Devices
  2. Medical Devices

Medical Devices

Medikal Cihazlar

ASSESSMENT OF BIOCOMPATIBILITY;

Medical device manufacturers use data from a variety of analytical, in vitro and In vivo (animal) testing procedures to demonstrate the safety and efficacy of their products. The ISO 10993 series of standards describes the basic biocompatibility testing requirements of medical devices.

BIOCOMPATIBILITY TEST METHODS;

There are some special procedures recommended for biocompatibility testing. The following tests do not imply that all procedures are required for any particular device or indicate that they are stand-alone tests available.

Cytotoxicity (Cell Culture)
Sensitization Tests (Sensitization)
Irritation Tests (Irritation)
Acute Systemic Toxicity
Subchronic Toxicity
Genotoxicity (Mutagenicity)
Implantation Tests
Hemocompatibility (Hemolytic Effect % HO)
Carcinogenicity
Reproductive and Developmental Toxicity
Pharmacokinetic (ADME)
Pre-Clinical Safety Test (Chemical Characterization)
Histopathology Services (Microscopy, Clinical Chemistry)

“ITS YOUR MEDICAL DEVICES TEST"

 

 

 

Cytotoxicity

Sensitization

Irritation

Systemic Toxicity

Subchronic Toxicity

Genotoxicity

Implantation

Blood Compatibility

Chronic Toxicity

Carcinogenicity

Surface Devices

Skin

< 24 Hours

X

X

X

 

 

 

 

 

 

 

24 Hours – 30 Days

X

X

X

 

 

 

 

 

 

 

> 30 Days

X

X

X

 

 

 

 

 

 

 

Mucosal Membrane

< 24 Hours

X

X

X

 

 

 

 

 

 

 

24 Hours – 30 Days

X

X

X

O

O

 

O

 

 

 

> 30 Days

X

X

X

O

X

X

O

 

O

 

Deteriorated or Damaged Surface

< 24 Hours

X

X

X

O

 

 

 

 

 

 

24 Hours – 30 Days

X

X

X

O

O

 

O

 

 

 

> 30 Days

X

X

X

O

X

X

O

 

O

 

Devices with External Contact

blood, non-direct

< 24 Hours

X

X

X

X

 

 

 

X

 

 

24 Hours – 30 Days

X

X

X

X

O

 

 

X

 

 

> 30 Days

X

X

O

X

X

X

O

X

X

X

Tissue/Bone/Tooth Contact

< 24 Hours

X

X

X

O

 

 

 

 

 

 

24 Hours – 30 Days

X

X

X

X

X

X

X

 

 

 

> 30 Days

X

X

X

X

X

X

X

 

X

X

Blood circulation

< 24 Hours

X

X

X

X

 

O

 

X

 

 

24 Hours – 30 Days

X

X

X

X

X

X

X

X

 

 

> 30 Days

X

X

X

X

X

X

X

X

X

X

Implant Devices

Tissue/Bone

< 24 Hours

X

X

X

O

 

 

 

 

 

 

24 Hours – 30 Days

X

X

X

X

X

X

X

 

 

 

> 30 Days

X

X

X

X

X

X

X

 

X

X

Able to

< 24 Hours

X

X

X

X

X

 

X

X

 

 

24 Hours – 30 Days

X

X

X

X

X

X

X

X

 

 

> 30 Days

X

X

X

X

X

X

X

X

X

X


X: Result of tests according to ISO 10993-1
O: Final tests according to FDA
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