Vacuum Cleaner as a Class IIa Medical Device?

D

DangerousDave

#1
Hi All

We recently sent a new product to the notified body for approval and has failed in a couple of things.

One I am stuck on is this product uses a vacuum cleaner as part of the product, and this (according to the NB) is going to need to be classed as a medical device (or accessory) as it is used with a Class IIa medical device.

The vacuum cleaner itself is CE marked, and is tested to IEC 60335-1, -2-2 and -2-6 and EN 55014-1 and -2 and EN 50336 according to the manufacturer but is clearly not a medical device.

60335 is safety related, and 55014 and 50336 are EMC.

Is anyone aware of a comparison chart between these standards and 60601? Or does someone have a copy of these standards?

I know it is cheeky to ask for the second one, but at this stage the new product is in the balance, and the company are unlikely to fork out to purchase these standards unless they proved usefull, and so I am in a catch 22 as I cannot make that assessment without having them.

D
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: Vacuum Cleaner As A Medical Device?

Sorry, Dave. We have a policy here in the Cove against supplying copyrighted material. Perhaps a kind soul who is familiar with these Standards can give you an overview of whether they are pertinent BEFORE you buy them. Sad to say, a big part of compliance is being familiar with and having up-to-date access to regulations and Standards which apply to your product and business. That means, like it or not, if these Standards ARE applicable to your organization, it will have to bite the bullet and buy them.

Some other folks MAY be able to steer you to an authorized organization which sells these documents at a rock bottom price. I'm aware some government-associated Quality organizations often do this, eschewing the profit Standards organizations build in for distributors to entice them to market the Standards.
 
D

DangerousDave

#3
Re: Vacuum Cleaner As A Medical Device?

I did think that might be the case!

I guess we'll have to bite the bullet and buy them unless anyone can help in a different way?

Thanks

Dave
 

Wes Bucey

Quite Involved in Discussions
#4
Re: Vacuum Cleaner As A Medical Device?

Hang in there - it's early days. Most responses in public forums are not instantaneous.
 
A

Asherlee

#5
The official website of the IEC often publishes a preview of standards. The preview usually includes the TOC (Table of Contents) of the standard. By looking at the TOC, you can get an idea of the areas covered by the standard and its relevance to your needs.

Good luck.

Asherlee
 
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