Class A medical device only. vulnerability) of the orifice to such invasion. - are in Class A if they are intended for Examples: examination gloves; enema devices. transient use; - are in Class B if they are intended for Examples: urinary catheters, tracheal tubes. short-term use; unless they are intended for short-term Examples: dressings for nose bleeds. use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class A, - are in Class C if they are intended for Example: urethral stent; contact lenses for long-term use; term continuous use (for this device, removal of the lens for cleaning is considered as part of the continuous use). unless they are intended for long-term Examples: orthodontic materials, removable use in the oral cavity as far as the dental prosthesis. pharynx, in an ear canal up to the or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class B. All invasive devices with respect to Examples: tracheal tubes connected to a body orifices (other than those which ventilator; suction catheters for stomach are surgically invasive) that are drainage; dental aspirator tips. intended to be connected to an active NOTE: Independent of the time for which they medical device in Class B or a higher are invasive. class, are in Class B. Rule 6. All surgically invasive devices A majority of such devices fall into several intended for transient use are in Class major groups: those that create a conduit through B, the skin (e.g. syringe needles; lancets), surgical instruments (e.g. single-use scalpels; surgical staplers; single-use aortic punch); surgical gloves; and various types of catheter/sucker etc. unless they are reusable surgical Examples: Manually operated surgical drill bits instruments, in which case they are in and saws. Class A; or NOTE: A surgical instrument connected to an active device is in a higher class than A. intended to supply energy in the Example: catheter containing sealed unless form of ionizing radiation, in which radioisotopes.
Class A medical device only. vulnerability) of the orifice to such invasion. - are in Class A if they are intended for transient use; Examples: examination gloves; enema devices. - are in Class B if they are intended for short-term use; Examples: urinary catheters, tracheal tubes. unless they are intended for short-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class A, Examples: dressings for nose bleeds. - are in Class C if they are intended for long-term use; Example: urethral stent; contact lenses for continuous use (for this device, removal of the lens for cleaning is considered as part of the continuous use). unless they are intended for long-term use in the oral cavity as far as the pharynx, in an ear canal up to the or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class B. Examples: orthodontic materials, removable dental prosthesis. All invasive devices with respect to body orifices (other than those which are surgically invasive) that are intended to be connected to an active medical device in Class B or a higher class, are in Class B. Examples: tracheal tubes connected to a ventilator; suction catheters for stomach drainage; dental aspirator tips. NOTE: Independent of the time for which they are invasive. Rule 6. All surgically invasive devices intended for transient use are in Class B, A majority of such devices fall into several major groups: those that create a conduit through the skin (e.g. syringe needles; lancets), surgical instruments (e.g. single-use scalpels; surgical staplers; single-use aortic punch); surgical gloves; and various types of catheter/sucker etc. unless they are reusable surgical instruments, in which case they are in Class A; or Examples: Manually operated surgical drill bits and saws. NOTE: A surgical instrument connected to an active device is in a higher class than A. unless intended to supply energy in the form of ionizing radiation, in which Example: catheter containing sealed radioisotopes. term
ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.docx