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IEVref:871-06-06ID:
Language:enStatus: Standard
Term: medical device
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Definition: 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 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 that 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 reproduction technologies.



Publication date:2018-05-09
Source:ISO 13485:2016, 3.11, modified – "may" corrected to "can", and the source reference omitted.
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