IEC 62366-1 published - March 2015

M

Marcelo

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

liuyy

Involved In Discussions
Marcelo Antunes said:
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.
Click to expand...

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

Marcelo

Inactive Registered Visitor
What is the main difference between IEC 62366-1：2015 and IEC 62366：2007？
Click to expand...

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

Sheemah

Starting to get Involved
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
 
M

Marcelo

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

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).
 
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