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Status:Closed    Asked:Oct 19, 2012 - 05:45 AM

hi! how do I choose the environmental conditions (min. and max. temperature and humidity) for a medical device?Txs

 
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Hi,


It really depends on the purpose of the test. Is this reliability or packaging test?


From my experience with testing medical device packaging, profiles may vary slightly from test to test. However, you probably want to stress outter packaging for three environmental extremes before proceeding with distribution simulation testing: (cold, dry and wet)


Example of environmental conditioning profile for MDP:

-18 C (uncontrolled RH) @ 24hr

38 C (85% RH) @ 24hr

60 C (30% RH) @24hr

Source: http://www.testopac.com

 

Oct 23, 2012 - 05:01 PM

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