Date : 10-11-08 11:11
MDD_Invasive devices
 Name : CE Manager
Hit : 428  
2. Invasive devices

2.1. Rule 5

 All invasive devices with respect to body orifices, other than
surgically invasive devices and which are not intended for connection to
an active medical device or which are intended for connection to an active
medical device in Class I:

— are in Class I if they are intended for transient use,

— are in Class IIa if they are intended for short-term use, except if they
are used 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 I,

— are in Class IIb if they are intended for long-term use, except if they are
used in the oral cavity as far as the pharynx, in an ear canal up to the
ear drum or in a nasal cavity and are not liable to be absorbed by the
mucous membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than surgically
invasive devices, intended for connection to an active medical device in
Class IIa or a higher class, are in Class IIa.