S
sonic85
Hi Everyone,
Can some please advise on whether the temperature/time datalogger device
(intended to validate the performance of autoclaves and has software that can make pass/fail determinations on sterilization cycles according to user defined parameters) would be regulated in the EU as medical device??
I took a look at the MDD Annex IX classification rules and was wondering if autoclaves (steam sterilizers) are Class IIa per Rule 15? If so, would an autoclave validation system as described above be considered an accessory?
Your help is really appreciated.
Can some please advise on whether the temperature/time datalogger device
(intended to validate the performance of autoclaves and has software that can make pass/fail determinations on sterilization cycles according to user defined parameters) would be regulated in the EU as medical device??
I took a look at the MDD Annex IX classification rules and was wondering if autoclaves (steam sterilizers) are Class IIa per Rule 15? If so, would an autoclave validation system as described above be considered an accessory?
Your help is really appreciated.