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
Rule 13. All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, and which is liable to act on the human body with action ancillary to that of the devices, are in Class D. These medical devices incorporate medicinal substances in an ancillary role. Examples: antibiotic bone cements; catheters; wound dressings incorporating antimicrobial agents to provide ancillary action on the wound; blood bags incorporating an NOTE: In some jurisdictions such products: are considered to be outside the scope of the medical device definition; may be subject to different controls. Rule 14. All devices manufactured from or incorporating animal or human cells/tissues/derivatives thereof, whether viable or non-viable, are in Class D, Example: porcine heart valves. NOTE: In some jurisdictions such products: are considered to be outside the scope of the medical device definition; may be subject to different controls. unless such devices are manufactured from or incorporate non-viable animal tissues or their derivatives that come in contact with intact skin only in which case they are in Class A. Examples: leather components of orthopaedic appliances. Rule 15. All devices intended specifically to be used for sterilising or disinfecting medical devices are in Class B. Example: desk-top sterilisers for use with dental instruments. unless they are disinfectant solutions or washer-disinfectors intended specifically for invasive medical devices, as the end point of processing, in which case they are in Class C; or Examples: solutions intended to be used for the disinfection of medical devices without further processing (for example in a steriliser) including those where the infective agent is a prion; washer-disinfector equipment specifically for disinfecting an endoscope or another invasive device. unless they are intended to clean medical devices by means of physical action only, in which case they are in Class A.