Table 10.

FDA and ISO medical device categorization, summarized from [73].

	Category	Contact Location	The Duration of Contact
Meaning	Nature of body contact	It refers to whether it directly has contact with the body in terms of blood, tissues, or skin.	Refers to the duration of contact between the material and the patient.
Categories	Surface device External Communicating device Implants	It is different based on the category.	Limited (less than 24 h) Prolonged (over 24 h but less than 30 days) Permanent (over 30 days)