The aim of this document is to establish a standardized approach for Human Subject Testing considering varying performance requirements of different user groups on aircraft as Flight Crew, Cabin Crew and Passengers.
The document will provide guidance for definition of significant topics relevant to equipment and system certification. The document will include information regarding ethical aspects, criteria to select human subjects for testing, safety of test subjects, requirements to medical personnel to attend tests and in particular if humans are exposed to elevated altitudes. Recommendation will be provided regarding test result monitoring and data validity
Rationale: Purpose of this Aerospace Information Report is to provide guidance for Human Subject Testing. Current Airworthiness Requirements define performance of oxygen equipment in terms of mechanical parameters (Volume, Flow, Partial Pressure) at specified altitudes. New technologies do not fit into these categories. Therefore Arterial Oxygen Saturation (SaO2) as direct biological indicator will be used to determine equipment performance based on Human Subject Testing.