D
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
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