A standard that gives requirements for medical device transportation studies?

[lilybef]

Hi all! Does anyone out there know of a standard that gives requirements for transportation studies? I need to have it cover shock, vibration, temperature and humidity for a medical device. I thought it was included in IEC 60601, but I can't find it.

[harry]

Any takers??

[Stijloor]

In Reply to Parent Post by lilybef

Hi all! Does anyone out there know of a standard that gives requirements for transportation studies? I need to have it cover shock, vibration, temperature and humidity for a medical device. I thought it was included in IEC 60601, but I can't find it.

I could not find a standard, but could this be of any help?

I tried.....

Stijloor.

[yodon]

You might also give ASTM a look:

http://www.astm.org/cgi-bin/SoftCart....htm?E+mystore

That's the standards we've used for medical device transport.

[Biobry]

Try ASTM D4169. This deals with transportation distribution testing. This is the method that we have used several times. It covers a broad range of scenarios so you would have to choose which is most appropriate.

[lilybef]

Thanks! I'll give ASTM D4169 a try!

[MIREGMGR]

Are you working to implement ISO 11607?

I don't have resources here at home, but if I have time Monday I'll try to post info on what we've agreed with our third party packaging test lab will be done in those regards.

That program is run by our Engineering Department, or I'd be more familiar with it.