M
Hello,
I heard about a EU proposal about IVD reglementation :
proposal_2012_541_en.pdf
This project use a part of the GHTF recomandations about IVD classification criteria's (Annex VII). This classification is made of letters from A to D.
Do anybody know if this classification will have a direct link with IEC 62304 security classes ?
For Example :
Is IVD class C equivalent to IEC 62304 class C ?
I heard about a EU proposal about IVD reglementation :
proposal_2012_541_en.pdf
This project use a part of the GHTF recomandations about IVD classification criteria's (Annex VII). This classification is made of letters from A to D.
Do anybody know if this classification will have a direct link with IEC 62304 security classes ?
For Example :
Is IVD class C equivalent to IEC 62304 class C ?