ASTM standard on ventilators for emergency and transport??

[MHultermans]

Hey you all!

I hope you can help me with the following..

We want to market an emergency and transport ventilator in the USA and therefore we need to submit a premarket notification with the FDA. There are a couple of guidance documents available that we intend to use:
-The draft reviewer guidance for ventilators (1995)
-The draft reviewer guidance for premarket notification submissions (1993)

These guidance documents refer to several standards, e.g. ASTMF1100-90 (1997) (withdrawn and replaced by ANS/IEC60601-2-12) and ASTMF1246-91(1999), none of which apply for emergency and transport ventilators..

I am wondering what to do here...

Should we refer to a standard that does appy (e.g. ISO10651-3 (CAN/CSA) or EN794-3) or is there another standard??

Any help would be appreciated, thanx!

 

[Goahead]

Hi,
the Underwriters Laboratories, Inc., at

http://www.ul.com/

could probably help you out in finding the documents you are requested to comply to.
Regards.

http://www.welding-advisers.com/

 

[CoryPad]

I think you should work with the ISO 10651-3 document.

Regards,

Cory

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