Difference between revisions of "Medical device"
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|description=A '''medical device''' is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. | |description=A '''medical device''' is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. | ||
|info=http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm | |info=http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm | ||
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:::» [[In vitro diagnostic medical device]] | :::» [[In vitro diagnostic medical device]] | ||
:::* Specifically, a | :::* Specifically, a medical device pursues one or more of the following purposes: | ||
::::* diagnosis, prevention, monitoring, treatment or alleviation of disease; | ::::* diagnosis, prevention, monitoring, treatment or alleviation of disease; | ||
::::* diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; | ::::* diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; | ||
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:::* '''Intended use''' or '''Intended purpose''' is the objective intend of a medical device manufacturer regarding the use of a product, process or service as it is documented by the manufacturer. The purpose of defining an '''intended use''' is to (https://www.johner-institut.de/blog/regulatory-affairs/zweckbestimmung/): | :::* '''Intended use''' or '''Intended purpose''' is the objective intend of a medical device manufacturer regarding the use of a product, process or service as it is documented by the manufacturer. The purpose of defining an '''intended use''' is to (https://www.johner-institut.de/blog/regulatory-affairs/zweckbestimmung/): | ||
::::* decide if a product is a | ::::* decide if a product is a medical device | ||
::::* classify the | ::::* classify the medical device | ||
::::* analyse risks within [[risk management]] processes | ::::* analyse risks within [[risk management]] processes | ||
::::* fullfill regulatory [[requirement]]s | ::::* fullfill regulatory [[requirement]]s | ||
Latest revision as of 05:15, 19 July 2022
- high-resolution terminology - matching measurements at high-resolution
Medical device
Description
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Reference: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
MitoPedia O2k and high-resolution respirometry:
Oroboros QM
- » In vitro diagnostic medical device
- Specifically, a medical device pursues one or more of the following purposes:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- 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 for medical purposes by means of in vitro examination of specimens derived from the human body;
- » In vitro diagnostic medical device
- Intended use or Intended purpose is the objective intend of a medical device manufacturer regarding the use of a product, process or service as it is documented by the manufacturer. The purpose of defining an intended use is to (https://www.johner-institut.de/blog/regulatory-affairs/zweckbestimmung/):
- decide if a product is a medical device
- classify the medical device
- analyse risks within risk management processes
- fullfill regulatory requirements
