Q
Qara5
Hello! This is my first post so I hope someone can help me.
At my company we sell a medical device into many markets including the EU and US. We are CE marked in the EU and FDA approved in the US. We tested to 60601 on the recommendation of our NB (As an aside I'm not 100% convinced this was correct as whilst we are definitely medical equipment we are never in the vicinity of the patient so maybe 61010 would have been more appropriate).
We are now looking to sell the same device into the life sciences market. Outside a medical setting our device would appear to be laboratory equipment. So my question is this - does our 60601 testing cover our medical device for non-medical research purposes or do we need to retest it against 61010?
At my company we sell a medical device into many markets including the EU and US. We are CE marked in the EU and FDA approved in the US. We tested to 60601 on the recommendation of our NB (As an aside I'm not 100% convinced this was correct as whilst we are definitely medical equipment we are never in the vicinity of the patient so maybe 61010 would have been more appropriate).
We are now looking to sell the same device into the life sciences market. Outside a medical setting our device would appear to be laboratory equipment. So my question is this - does our 60601 testing cover our medical device for non-medical research purposes or do we need to retest it against 61010?