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UVC sterilizer CE Mark

#1
Hello everybody,

I want to ask you about UVC sterilizer CE Mark. Which directive is used for confirmation of sterilization feature of this device for CE marking? We found a device and it has a CE mark but according to The EMC Directive 2014/30/EU. I think this doesn't comprise sterilization feature.

Thanks and regards.

Gizem
 
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Benjamin Weber

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#2
What does the device sterilize? If it is used to sterilize medical devices it is medical device itself and should comply with the corresponding medical device directive (MDD). Otherwise it should at least comply with the low voltage directive (LVD). Do you have the declaration of conformity? This should state the underlying directive and maybe also the standards which were applied to show compliance. For such sterilizer I would expect at least IEC 61010-1 and IEC 61010-2-040.
 
#3
What does the device sterilize? If it is used to sterilize medical devices it is medical device itself and should comply with the corresponding medical device directive (MDD). Otherwise it should at least comply with the low voltage directive (LVD). Do you have the declaration of conformity? This should state the underlying directive and maybe also the standards which were applied to show compliance. For such sterilizer I would expect at least IEC 61010-1 and IEC 61010-2-040.
Actually we are thinking of buying and then selling it. But we are not sure of the LVD or EMC directives are enough or not. In this case, can we say that UV is an approved sterilization source so that CE mark is for just its physical features, there is no need to any confirmation for its sterilization feature? In addition, I think it is not for medical device sterilization, not sure of the goal. But yes IEC 61010-1 and IEC 61010-2-040 seem appropriate. Thank you for your reply.
 

Benjamin Weber

Trusted Information Resource
#4
Actually we are thinking of buying and then selling it. But we are not sure of the LVD or EMC directives are enough or not. In this case, can we say that UV is an approved sterilization source so that CE mark is for just its physical features, there is no need to any confirmation for its sterilization feature? In addition, I think it is not for medical device sterilization, not sure of the goal. But yes IEC 61010-1 and IEC 61010-2-040 seem appropriate. Thank you for your reply.
You are going to sell the UV sterilizer, but you don't know what it shall be used for?!? What is the intended use specified by the manufacturer?

I don't think you can say UV sterilization is an approved method and that's it. The manufacturer should somehow show, that the disinfection process is appropriate to achieve the desired result. That can be done by applying the right standard, e.g. 61010-2-040.

If you want to sell the device, you should be aware of your obligations, depending on the corresponding market (I assume EU) and the relevant directives. I am sure, any of the directives will require at least, that you know, what you are selling! Are you acitng as importer, EU representative, distributer?
 
#5
You are going to sell the UV sterilizer, but you don't know what it shall be used for?!? What is the intended use specified by the manufacturer?

I don't think you can say UV sterilization is an approved method and that's it. The manufacturer should somehow show, that the disinfection process is appropriate to achieve the desired result. That can be done by applying the right standard, e.g. 61010-2-040.

If you want to sell the device, you should be aware of your obligations, depending on the corresponding market (I assume EU) and the relevant directives. I am sure, any of the directives will require at least, that you know, what you are selling! Are you acitng as importer, EU representative, distributer?
Actually I don't think it is about our company. We are producing medical devices and we will get CE certification about our products soon. My manager sent me a CE certificate of a UVC sterilizer and asked about its sterilization compliance "Does the certificate include sterilization function, too". We are not going to produce it. Importing or distributing it I guess, I don't know why did they ask me about it, maybe they wanted to be sure of this product's safety. But I do not know about UVC sterilizers, because my field is on Class IIb and Class III medical devices. To be sure about the certificate content, I wanted to ask about the requirements.
 
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