rangani_rj
Involved In Discussions
Hi All,
Do we need to register steam generator as medical device?
Confusion is that some large sterilizers approved in EU have integrated small steam generator but in our case it is placed outside of premises and steam is then transported to sterilizer (small, large, stations). Steam is also used for other purposes, only small part of which is used for sterilizing medical device.
I also found that Pressurized Equipment Directive (PED) is applicable to this unit (as pressure is above 0.5 bar) and it also requires CE marking. Could we use this directive (if MDD is not applicable). Again second question arises here "can we include PED complied device (generator) while showing conformity for MDD device (steam sterilizer)".
I will be grateful who can assist and thanks in advance
Do we need to register steam generator as medical device?
Confusion is that some large sterilizers approved in EU have integrated small steam generator but in our case it is placed outside of premises and steam is then transported to sterilizer (small, large, stations). Steam is also used for other purposes, only small part of which is used for sterilizing medical device.
I also found that Pressurized Equipment Directive (PED) is applicable to this unit (as pressure is above 0.5 bar) and it also requires CE marking. Could we use this directive (if MDD is not applicable). Again second question arises here "can we include PED complied device (generator) while showing conformity for MDD device (steam sterilizer)".
I will be grateful who can assist and thanks in advance