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Hi Marcelo,
my company manufactures a medical device software used in radiology. we're ISO 13485 certified and the product is classified as a PACS even though is actually a stand alone software. Our list of applicable standard included IEC 60601-1-1, IEC 60601-1-4, and IEC 60601-1-6. Because of the IEC 60601 3rd edition I did a Gap Analysis but I think that our SW doesn't fall under the definition of Medical Electrical Equipment (or system) according to IEC 601; so I decided that the new standard shouldn't be part of the list and I took it out. We claim compliance with IEC 62304 though and now I'm thinking if I have to claim compliance also with IEC 60601 clause 14 (which refer to the old 60601-1-4) because of the SW validation. (please note that we are also 510k cleared and our SW life-cycle has also to meet SW verification and validation under FDA point of view which is slightly different from ISO's).
I hope this is the right place to post my question. (there are so many forums related!)
thanks if you can help.
Patrizia.
my company manufactures a medical device software used in radiology. we're ISO 13485 certified and the product is classified as a PACS even though is actually a stand alone software. Our list of applicable standard included IEC 60601-1-1, IEC 60601-1-4, and IEC 60601-1-6. Because of the IEC 60601 3rd edition I did a Gap Analysis but I think that our SW doesn't fall under the definition of Medical Electrical Equipment (or system) according to IEC 601; so I decided that the new standard shouldn't be part of the list and I took it out. We claim compliance with IEC 62304 though and now I'm thinking if I have to claim compliance also with IEC 60601 clause 14 (which refer to the old 60601-1-4) because of the SW validation. (please note that we are also 510k cleared and our SW life-cycle has also to meet SW verification and validation under FDA point of view which is slightly different from ISO's).
I hope this is the right place to post my question. (there are so many forums related!)
thanks if you can help.
Patrizia.