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Testing of Medical Devices according ISO 10993

The evaluation of possible interactions and potential secondary effects of medical devices in contact with the human body is required by the regulatory authorities.  Medical devices can be divided into different categories. Based on the contact and the contact time in the human body, the necessary tests can be determined for the biological evaluation of the medical product. Performing these analyses in a GLP accredited laboratory will ensure the complete conformity of the results with the requirements of the different parts of the ISO 10993.

Together with our partner laboratories, we offer you the necessary tests for a biological evaluation of your medical device in accordance with ISO 10993 under the principles of Good Laboratory Practice (GLP) as well as a risk assessment of your product:

  • ISO 10993-3:     Genotoxicity, carcinogenicity and  reproductive toxicity
  • ISO 10993-4:     Selection of tests for interaction with blood
  • ISO 10993-5:     Tests for in vitro cytotoxicity
  • ISO 10993-6:     Tests for local effects after implantation
  • ISO 10993-7:     Ethylene oxide sterilization residuals
  • ISO 10993-10:   Tests for irritation and skin sensitization
  • ISO 10993-11:   Tests for systemic toxicity

The following table demonstrates the different categories in which your medical device can be classified and the corresponding tests for biocompatibility that are necessary for admission.

Nature of body contact
Contact duration *
Cytotoxicity
Sensitization
Irritation or
Intracutaneous reactivity
Acute systemic toxicity
Subacute / subchronic toxicity
Genotoxicity
Implantation
Haemocompatibility
Surface device
Intact skin A x x x          
B x x x          
C x x x          
Mucosal membrane A x x x          
B x x x o o   o  
C x x x o x x o  
Breached or compromised surface A x x x o        
B x x x o o   o  
C x x x o x x o  
External communicating device
Blood path, indirected A x x x x       x
B x x x x o     x
C x x o x x x o x
Tissue/bone/dentin + A x x x o        
B x x x x x x x  
C x x x x x x x  
Circulating blood A x x x x   o*   x
B x x x x x x x x
C x x x x x x x x
Implant device
Tissue/bone A x x x o        
B x x x x x x x  
C x x x x x x x  
Blood A x x x x x   x x
B x x x x x x x x
C x x x x x x x x

Source: ISO 10993-1: Biological Evaluation of Medical Devices Part 1, Attachment A, 2013

*Contact duration:
A - limited (≤ 24 h)
B - prolonged (> 24 h to 30 d)
C - permanent (> 30 d)
X = ISO Evaluation Tests for Consideration
O = Additional Tests which may be applicable
Note * For all devices used in extracorporeal circuits