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What is the classification for a medical device intended for transient use?
What is the classification for a medical device intended for transient use?
Which class of medical devices holds the highest risk according to the European framework?
Which class of medical devices holds the highest risk according to the European framework?
Which of the following is true for non-invasive medical devices?
Which of the following is true for non-invasive medical devices?
What duration of use qualifies a medical device for short-term classification?
What duration of use qualifies a medical device for short-term classification?
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Which of the following specialties is associated with medical devices classified under 'AN'?
Which of the following specialties is associated with medical devices classified under 'AN'?
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Which class of medical device is typically associated with long-term use?
Which class of medical device is typically associated with long-term use?
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How is a device defined as long-term use?
How is a device defined as long-term use?
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What classification is given to a transient invasive medical device that is not intended to be connected to an active medical device?
What classification is given to a transient invasive medical device that is not intended to be connected to an active medical device?
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Which of the following situations would classify a device as Class IIb?
Which of the following situations would classify a device as Class IIb?
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What is one criterion for classifying medical devices under the highest risk classification?
What is one criterion for classifying medical devices under the highest risk classification?
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In which situation would a non-invasive medical device be classified at a higher level than Class I?
In which situation would a non-invasive medical device be classified at a higher level than Class I?
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What classification is assigned to an active medical device for therapy designed to deliver energy to a patient?
What classification is assigned to an active medical device for therapy designed to deliver energy to a patient?
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What is the main purpose of product codes in medical device classification?
What is the main purpose of product codes in medical device classification?
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How is an active medical device classified if it has potentially hazardous energy administration?
How is an active medical device classified if it has potentially hazardous energy administration?
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In which scenario is an invasive device classified as Class I instead of Class IIa for short-term use?
In which scenario is an invasive device classified as Class I instead of Class IIa for short-term use?
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Which classification applies to invasive medical devices intended for short-term use in the ear canal up to the eardrum?
Which classification applies to invasive medical devices intended for short-term use in the ear canal up to the eardrum?
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What classification is given to invasive devices that are for long-term use and are intended to be absorbed by mucous membranes?
What classification is given to invasive devices that are for long-term use and are intended to be absorbed by mucous membranes?
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If an invasive medical device is connected to an active medical device classified as Class IIa or higher, what is the classification of the invasive device?
If an invasive medical device is connected to an active medical device classified as Class IIa or higher, what is the classification of the invasive device?
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What classification is assigned to a transient invasive medical device intended to be used in a nasal cavity?
What classification is assigned to a transient invasive medical device intended to be used in a nasal cavity?
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Which of the following correctly identifies an active medical device that is not for therapy?
Which of the following correctly identifies an active medical device that is not for therapy?
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What classification is given to an active medical device intended to control or monitor the performance of another active medical device for therapy?
What classification is given to an active medical device intended to control or monitor the performance of another active medical device for therapy?
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Under what condition is an active medical device classified as Class IIa?
Under what condition is an active medical device classified as Class IIa?
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Which type of active medical device is classified as Class IIb?
Which type of active medical device is classified as Class IIb?
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What is the classification for an active medical device intended to emit ionizing radiation for therapeutic purposes?
What is the classification for an active medical device intended to emit ionizing radiation for therapeutic purposes?
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Which of the following devices is classified as Class I?
Which of the following devices is classified as Class I?
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What determines that an active medical device is classified as Class I?
What determines that an active medical device is classified as Class I?
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An active medical device that monitors vital physiological parameters with potential for immediate danger is classified as what?
An active medical device that monitors vital physiological parameters with potential for immediate danger is classified as what?
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Which statement is true regarding Class IIa medical devices?
Which statement is true regarding Class IIa medical devices?
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What is a common characteristic of Class IIb medical devices?
What is a common characteristic of Class IIb medical devices?
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Which classification applies to an active medical device solely used for non-invasive assessments?
Which classification applies to an active medical device solely used for non-invasive assessments?
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Which classification applies to a non-invasive medical device designed to channel or store blood for infusion?
Which classification applies to a non-invasive medical device designed to channel or store blood for infusion?
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What classification is assigned to non-invasive medical devices that modify the biological or chemical composition of blood?
What classification is assigned to non-invasive medical devices that modify the biological or chemical composition of blood?
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Which classification is used for a device that is intended to be used in contact with injured skin?
Which classification is used for a device that is intended to be used in contact with injured skin?
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What classification applies to non-invasive devices primarily meant for wounds that have breached the dermis?
What classification applies to non-invasive devices primarily meant for wounds that have breached the dermis?
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Which type of device is classified as Class IIa when it involves filtration, centrifugation, or gas exchanges?
Which type of device is classified as Class IIa when it involves filtration, centrifugation, or gas exchanges?
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What best describes the classification of a device intended for storage of body tissue before reintroduction?
What best describes the classification of a device intended for storage of body tissue before reintroduction?
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Which classification is NOT correct for non-invasive medical devices used in contact with injured skin?
Which classification is NOT correct for non-invasive medical devices used in contact with injured skin?
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What classification applies to a device intended to store an organ before introduction into a patient?
What classification applies to a device intended to store an organ before introduction into a patient?
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In which scenario would a non-invasive medical device be classified as Class I?
In which scenario would a non-invasive medical device be classified as Class I?
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Study Notes
Medical Device Classification
- Medical devices are classified differently in various countries.
- The European framework classifies devices into four classes: Class I, IIa, IIb, and III.
- Class III devices, similar to FDA Class III, pose the highest risk.
Duration of Use
- A device is considered for transient use if continuous use is less than 60 minutes.
- Short-term use is for continuous use at least 60 minutes but not exceeding 30 days.
- Long-term use implies continuous use exceeding 30 days.
Non-Invasive Medical Devices
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A non-invasive device is typically classified as Class I, unless another clause dictates a higher classification.
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Non-invasive devices channeling or storing blood or other fluids intended for infusion/administration are categorized as Class IIa.
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Non-invasive devices for storing organs or tissues awaiting transplantation are classified as Class IIa
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Devices intended for channeling or storing fluids (infusions, administer) are classified as Class Ila
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Non-invasive devices connected to active medical devices, classified as Class Ila or higher, are also Class Ila.
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Devices intended to modify blood or bodily fluid composition are classified as Class IIb.
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If the treatment involves filtration, centrifugation, or gas/heat exchange, it's classified as Class Ila.
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Non-invasive devices intending contact with injured skin are Class Ila, unless intended as a mechanical barrier, for compression, or for removing exudates.
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If the wound treatment needs secondary intent healing, it's classified as Class IIb.
Invasive/Implantable Medical Devices
- Invasive devices penetrating body orifices are Class I for transient use.
- Class IIa if for short-term use, unless specific body parts: oral cavity (to pharynx), ear canal, nasal cavity are involved, then it's Class I.
- Class IIb if for long-term use, unless involving specific body areas like oral cavity to pharynx, ear canal, and nasal cavity, which are classified as Class Ila.
- If connected to a Class IIa or higher active device, it's Class IIa.
Active Medical Devices
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Active medical devices are generally classified as Class I, unless another rule dictates otherwise.
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Devices for administering energy are Class Ila.
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If the energy method poses a hazardous risk of administering/removing energy, it's classified as Class IIb.
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Devices for energy control and influence are Class IIb.
Active Medical Devices for Diagnosis
- Active diagnosis devices are typically Class Ila, unless using energy absorption (by patient's body—not visible spectrum-only illumination).
- Class Ila for imaging of radiopharmaceuticals in vivo.
- Class Ila for direct diagnosis or monitoring processes.
- Class IIb if monitoring vital signs that can pose immediate danger to a patient (e.g., cardiac, respiratory function, CNS activity).
- Diagnostic devices for ionising radiation or therapeutic interventional radiology are Class IIb.
Active Medical Devices for Administering/Removing substances,
- Devices administering/removing medicines or bodily fluids from/to a patient are classified as Class Ila.
- If the administration or removal is potentially hazardous, it's Class IIb.
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Description
This quiz covers the classification of medical devices according to different frameworks, focusing on the European system. It explains the criteria for transient, short-term, and long-term use, as well as the distinctions between various classes of non-invasive devices. Test your knowledge on the essentials of medical device classification.
