M
medgar
I am having a little trouble navigating my way through the versions of standards that I need to comply with MDD 93/42/EEC.
En 60601-1 applies to my device. Amendment 1 of 60601-1 3rd edition quotes ISO 14971:2007 as a normative reference.
Which version, EN ISO 14971:2012 or ISO 14971:2007, am I required to comply with?
My thoughts are EN ISO 14971:2012 because risk assessment is applied to Essential Requirements (ER) beyond those ER covered by 60601-1.
Any advice would be greatly appreciated.
En 60601-1 applies to my device. Amendment 1 of 60601-1 3rd edition quotes ISO 14971:2007 as a normative reference.
Which version, EN ISO 14971:2012 or ISO 14971:2007, am I required to comply with?
My thoughts are EN ISO 14971:2012 because risk assessment is applied to Essential Requirements (ER) beyond those ER covered by 60601-1.
Any advice would be greatly appreciated.