Functions of a medical device and the definition of a medical device

[linikujp]

1. It has been discussed between Asiyah and Sivaram regarding to the function of a medical device, and Sivaram provided a talk by Barry Smith on Ontology for Systems Engineering (Short Version) where the function, capacity, operator, maintainer, designer of a system are mentioned. Those are good points for modeling a device which is a complicated system, such as a ventilator.

-- however, some simple device, such as a breast implant or tongue presser is not a system.

2. Other related work would be the functional ontology developed by Richio Mizuguchi and Dr. Kitamura, where a lot of general terms for "functioning process" have been developed and they are quite useful.

Kitamura:
http://www.ritsumei.ac.jp/~y-kita/index-en.html

Functional ontology related sites:

https://www.researchgate.net/publication/222684399_Ontology-based_description_of_functional_design_knowledge_and_its_use_in_a_functional_way_server

3. FDA's definition of a medical device is quite complex:
   https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
   -- opinions including not binding to the definitions by law to determine what is a medical device, or looking into other regulatory authorities definitions on medical devices.