Device Categorization

Categorizing the medical device is the first step in the biological evaluation of medical devices. Toxicity endpoints to be considered in the biocompatibility test battery are based on the category to which the medical device is categorized.

 

Medical devices are categorized based on the:  

• Nature of body contact and

• Duration of body contact

​

Categorization based on Nature of body contact

​

​

​

​

​

​

​

​

​

​

​

​

​

Categorization based on Duration of body contact