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Actors, roles and participants
The people and organisations involved in the managing and delivery of care, the roles they hold, their participation in care and the resources they use.
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury, — investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — disinfection of medical devices, — providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which can be assisted in its intended function by such means

Actors, roles and participants
The people and organisations involved in the managing and delivery of care, the roles they hold, their participation in care and the resources they use.
- care actor
  organization or person participating in care
- subject of care
  person seeking to receive, receiving, or having received care
- care provider
  care actor that is able to be assigned one or more care period mandates
- care organization
  organization being a care provider
- care employment
  contractual framework between a care personnel and a care organization describing the roles and responsibilities assigned to that care personnel
- care personnel
  person holding a care employment from a care organization
- care professional entitlement
  professional mandate held by a person concerning specific roles in care
- care professional
  person holding a care professional entitlement
- other carer
  person being a care third party
- care supporting organization
  organization that is a care third party
- subject of care proxy
  care actor exercising a proxy mandate
- care performer
  role adopted by care personnel when performing care
- self-care performer
  role played by a subject of care when performing self-care
- third party care performer
  role performed by a care third party
- prescriber
  role performed by a care professional when recommending or authorising a care activity
- care resource
  resource needed to perform care activities
- point of care
  location where direct care activities are performed
- medical device
  instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury, — investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — disinfection of medical devices, — providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which can be assisted in its intended function by such means
- automatic medical device
  medical device capable of performing care activities by itself or under human supervision
- medicinal product
  pharmaceutical product or combination of pharmaceutical products that may be administered to human beings for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions
- care funds
  resource provided for funding care delivery

medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury, — investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — disinfection of medical devices, — providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which can be assisted in its intended function by such means

Note 1 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.

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

Table 1. Specializations / Generalizations of **medical device**
Specialization of			Generalization of
physical object			automatic medical device
care resource

medical deviceUML Representation — Figure 1. medical device (UML Representation)