medical device

Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF)

Note 2 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others include:

- disinfection substances,

- aids for persons with disabilities,

- devices incorporating animal and/or human tissues,

- devices for in-vitro fertilization or assisted reproductive technologies.

Note 3 to entry: In certain regulatory jurisdictions, devices for cosmetic/aesthetic purposes are also considered medical devices.

Note 4 to entry: In certain regulatory jurisdictions, the commerce of devices incorporating human tissues is not allowed

[SOURCE: ISO/IEC Guide 63:2019, 3.7]

Table 1. Associations of medical device
Specialization of Generalization of
care resource automatic medical device
medical deviceUML Representation
Figure 1. medical device (UML Representation)