I have been looking to do some checks if there have been any newer editions released for the applicable standards followed by our company.
I need some guidance in understanding which adaptation of standards needs to be affirmed.
For example: As per ISO website the current edition of ISO 14971 is ISO14971:2007.
But the current CEN adaptation of the same has gone till EN ISO 14971:2012?
My company has CE marked products as well, so does it mean that we have to demonstrate compliance only with "EN" standards?
Please consider if I have made any errors as I am still a novice in understanding these details.
Thanks.
I need some guidance in understanding which adaptation of standards needs to be affirmed.
For example: As per ISO website the current edition of ISO 14971 is ISO14971:2007.
But the current CEN adaptation of the same has gone till EN ISO 14971:2012?
My company has CE marked products as well, so does it mean that we have to demonstrate compliance only with "EN" standards?
Please consider if I have made any errors as I am still a novice in understanding these details.
Thanks.