Does anyone have a good understanding of the application of ANSI/AAMI AT6?

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ElizabethAnne

Does anyone have a good understanding of the application of this?
In particular, 4.2.1 System Integrity makes demands of the integrity of the system. Is this asking for one-off design testing or on-going In-Process inspection?

In 4.2.1 b) it asks that the sytem shall withstand "a negative gauge pressure that is twice the recommended gauge pressure or one atmosphere of negative gauge pressure, whichever is smaller in absolute value". Is the latter not an absulute vacuum?

Any input appreciated.

Elizabeth Anne
 
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drewsky1

Has anyone done a gap analysis on the 2013 version from the 2005 version? Would like some input if possible on what some of the major changes are.
Thanks
 
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