Difference between revisions of "Medical device"

Revision as of 14:02, 23 February 2020

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

» 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;

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 --> classification
analyse risks within risk management processes
fullfill regulatory requirements

MitoPedia concepts: "MitoFit Quality Control System" is not in the list (MiP concept, Respiratory state, Respiratory control ratio, SUIT concept, SUIT protocol, SUIT A, SUIT B, SUIT C, SUIT state, Recommended, ...) of allowed values for the "MitoPedia concept" property. MitoFit Quality Control System"MitoFit Quality Control System" is not in the list (Enzyme, Medium, Inhibitor, Substrate and metabolite, Uncoupler, Sample preparation, Permeabilization agent, EAGLE, MitoGlobal Organizations, MitoGlobal Centres, ...) of allowed values for the "MitoPedia topic" property.

@@ Line 1: / Line 1: @@
 {{MitoPedia
-|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:
+|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.
-*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
-*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
 }}
+:::» [[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;
+:::* '''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]] --> [[classification]]
+::::* analyse risks within [[risk management]] processes
+::::* fullfill regulatory [[requirement]]s
 {{MitoPedia concepts
 |mitopedia concept=MitoFit Quality Control System
 }}
-{{MitoPedia methods}}
-{{MitoPedia O2k and high-resolution respirometry}}
-{{MitoPedia topics}}
-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;
- Author: [[User:Weber Benno|Weber Benno]] 17:45, 10 February 2016 (CET)