Steam sterilizer medical device reclassification

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ECHO

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#4
I ran your question through google translate and I got the following:
"How can I classify a steam sterilizer that is class IIb under MDD according to rule 16?"

What is your steam sterilizer intended to sterilize?
 

chris1price

Trusted Information Resource
#6
I have the same question, we would like to sanitize a surgeon helmet. would be then class 2 b acc to rule 16?
Per MDR rule 16 the device would be Class IIa as the surgeon helmet would not be invasive. If the device is used for anything that is invasive, then it would be Class IIb.

(All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.)
 

Malomsoki Gabor

Starting to get Involved
#7
Per MDR rule 16 the device would be Class IIa as the surgeon helmet would not be invasive. If the device is used for anything that is invasive, then it would be Class IIb.

(All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.)
ok thanks
 
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