IEC 62366-1 published - March 2015

[Marcelo]

Hey guys, just a general update, IEC 62366-1 was published some weeks ago.

IEC 62366-2 (which will be the guidance part) is still being discussed in the JWG.

 

[CBAL08]

But would still take some time until its harmonised in EU?

 

[Marcelo]

First it needs to get published but CENELEC, then it needs to go thru the harmonization process, so it may take some time.

 

[liuyy]

Hey guys, just a general update, IEC 62366-1 was published some weeks ago.

IEC 62366-2 (which will be the guidance part) is still being discussed in the JWG.

What is the main difference between IEC 62366-1：2015 and IEC 62366：2007？

 

[Marcelo]

What is the main difference between IEC 62366-1：2015 and IEC 62366：2007？

Hum, there´s no "main" difference (one specific topic), but there´s a lot of improvements.

 

[Sheemah]

Hi,

I have a question, does IEC 62366 apply only to the New Medical Device or it applies to the existing medical device as well?

Thanks,
Sheemah

 

[Marcelo]

I have a question, does IEC 62366 apply only to the New Medical Device or it applies to the existing medical device as well?

It does apply to new and existing devices. However, for legacy devices, there's an alternative process that can be used instead of using the whole process (which is simply impossible for legacy devices).

 

[Sheemah]

Thanks Marcelo!