|
Home > Archive > Electrical code Compliance > April 2007 > 14971 and 60601-1-4
You are viewing an archived Text-only version of the thread.
To view this thread in it's original format and/or if you want to reply to
this thread please [click here]
| Author |
14971 and 60601-1-4
|
|
| doneirik 2007-03-27, 9:25 am |
| Dear Forum,
Can anyone tell me the relationship between 14971 and 60601-1-4?
They both outline procedures for Risk Management. I expected the
60601-1-4 to refer to the 14971 somehow and was surprised when I
found no reference to 14971 in 60601-1-4.
Is there any differences to the Procedures outlined in 14971 to the
ones in 60601-1-4?
regards
doneirik
| |
|
| doneirik wrote:
> Dear Forum,
>
> Can anyone tell me the relationship between 14971 and 60601-1-4?
> They both outline procedures for Risk Management. I expected the
> 60601-1-4 to refer to the 14971 somehow and was surprised when I
> found no reference to 14971 in 60601-1-4.
>
> Is there any differences to the Procedures outlined in 14971 to the
> ones in 60601-1-4?
>
> regards
> doneirik
>
For the 3d ed of IEC 60601-1, risk management and
essential performance required by IEC 60601-1-4 is
directly addressed.
Also note that ISO 14971 can be considered mostly
"informative", but ISO 13485 is "normative", so you may
be looking in the wrong place.
So the short answer is that your requirements that
drive "risk management" must indicate the
software-related risks are acceptable, thus IEC
60601-1-4 is not applicable.
|
|
|
|
|