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B
FAA Compliance
To whom it may concern:
In line with the FAA Advisory Circular AC 91.21-1D October 27, 2017, this kind of respiratory 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 rec-
ommends 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 respiratory 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 rec-
ommends that customers check with their airline.
134
Appendix: B FAA Compliance
Doc. 007229 D-3
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