medical device and pharmaceutical industries with comprehensive sterilization, validation, and laboratory services
medical device and pharmaceutical industries with comprehensive sterilization, validation, and laboratory services
Device Categories Biological Effect
Initial
Evaluation Tests		 Supplementary
Evaluation Tests

ISO 10993-1 Test Matrix

key
 = standard ISO evaluation tests
2  For all devices used in extracorporeal circuits.
 = additional tests which may be applicable

 

Body Contact

 Contact
Duration
Surface Devices Skin Limited                  
Prolonged                  
Permanent                  
Mucosal Membrane Limited                  
Prolonged            
Permanent        
Breached or
Compromised
Surfaces		 Limited                
Prolonged            
Permanent        
External Communicating Devices Blood Path, Indirect Limited              
Prolonged            
Permanent    
Tissue/Bone/Dentin
Communicating1		 Limited                
Prolonged          
Permanent      
Circulating blood Limited   2          
Prolonged        
Permanent    
Implant
Devices		 Tissue/Bone Limited                
Prolonged          
Permanent      
Blood Limited            
Prolonged        
Permanent