11 FAA Compliance
To whom it may concern:
In line with the FAA Advisory Circular AC 91.21-1D October 27, 2017, this kind of respira-
tory assistive device may be used onboard an aircraft, without further testing by the carrier,
provided they have been tested for Electromagnetic Compatibility (EMC) in accordance
with the current version of RTCA/DO-160, Section 21, Category M.
Breas Medical has successfully completed testing for the ventilator System. The ventilator
System complies with RTCA/DO-160, Section 21, Category M and can be considered FAA
compliant.
Some airlines may require advance notification before travel, and devices may need to be
operated by battery. Breas Medical recommends that customers check with their airline.
FAA Compliance (English text)
To whom it may concern:
In line with the FAA Advisory Circular AC 91.21-1D October 27, 2017, this kind of respi-
ratory assistive device may be used onboard an aircraft, without further testing by the car-
rier, provided they have been tested for Electromagnetic Compatibility (EMC) in
accordance with the current version of RTCA/DO-160, Section 21, Category M.
Breas Medical has successfully completed testing for the ventilator System. The ventilator
System complies with RTCA/DO-160, Section 21, Category M and can be considered
FAA compliant.
Some airlines may require advance notification before travel, and devices may need to be
operated by battery. Breas Medical recommends that customers check with their airline.
FAA Compliance
145
Doc. 006553 M-6 User Manual
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