Medical Device Accessories vs. Detachable Parts

R

Rgpaula

According to the version 3.1, some new markings are defined for accessories and I was wondering if every detachable part (or component) is considered an accessory or not? If not, then subclause 7.2.4 is not appliable, right?
 
M

Marcelo

Inactive Registered Visitor
There's a definition of accessory in 3.3:

ACCESSORY
additional part for use with equipment in order to:
– achieve the INTENDED USE,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
Click to expand...

If the detachable part is under this definition, 7.2.4 does apply.
 
R

Rgpaula

Hi Marcelo, is there any definiton for detachable parts as well? I'm wondering if that "additional" term wouldn't mean something different. Example: in a dental driller composed by a driver unit, a "detachable" motor hand-piece and a footswitch (also detachable), is the hand piece an accessory? Even if they're sold together, shipped in the same box/package? Why would that be so important to have a SN and a date in the hand-piece?
 
rob73

rob73

looking for answers
Does the motor hand piece or foot switch have any identifying markings linking it to the original assembly? What if the hand piece had been transferred to another driver unit and you need to recall the hand unit, could it be traced? If the answer is no then it may be a good idea to consider marking the "detachable" part with some identifying mark.
 
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