M
Mawos78
Good morning,
My company is currently working to get all MEE devices compliant against 60601-1 3rd edition. Some products have to be slightly modified, to pass the test and/or the 3rd edition requierments.
Do we have to rework medical electric devices that have been already placed on the market before June 1st 2012 and are fullfilling 2nd edition requirements? Or are these modifications just needed for products placed on the market after June 1st 2012? And therefore the modifications do not have to be made on devices that have been sold (let's say) 1year ago?!?
What is your thought on this?
Thanks Martin
My company is currently working to get all MEE devices compliant against 60601-1 3rd edition. Some products have to be slightly modified, to pass the test and/or the 3rd edition requierments.
Do we have to rework medical electric devices that have been already placed on the market before June 1st 2012 and are fullfilling 2nd edition requirements? Or are these modifications just needed for products placed on the market after June 1st 2012? And therefore the modifications do not have to be made on devices that have been sold (let's say) 1year ago?!?
What is your thought on this?
Thanks Martin