1. Certification of Transport Medical Equipment
Flight Structures Ltd
Hamilton
Certification of Transport Medical Equipment
Ensuring Patient Safety and Wellbeing While in the Air
Chris Raynes
Senior Design and Certification Engineer

2. Flight Structures Ltd
Hamilton
Introduction
Taken individually each component of a medical fit-out is not complex but when combined into a medical system the certification complexity increases
There is often confusion from the customer as why equipment suitable for use in an intensive care medical environment requires such attention when used on an aircraft
There is a balancing act between patient well-being and airworthiness during medi-vac operations
What we are looking at is the certification of equipment used solely for the purpose of transferring critically ill patients to a medical facility.
With the customers always left wondering why they need to jump through so many hoops to gain aircraft installation approval.

3. MEDI-VAC OPERATION Evacuation or patient transfer
Flight Structures Ltd
Hamilton
MEDI-VAC OPERATION
Evacuation or patient transfer
Occupant is often critically ill
Medical staff are in constant attendance
Flight is at all times and all weather conditions
Role equipment is removable
Equipment is certified to medical standards

4. Medical Transport Equipment Certification
Flight Structures Ltd
Hamilton
Medical Transport Equipment Certification
Medical Transport Systems are designed to provide self contained life support and monitoring of a patient while in transit between medical facilities.

5. Flight Structures Ltd
Hamilton
Medical Equipment
A typical medical fit out will contain a wide range of medical equipment including but not limited to:
Monitor
Ventilator
Syringe pumps
Air / oxygen blender
Suction pump
Infant incubator
Heated mattress
Oxygen supply – portable bottle
Air supply – portable bottle
Patient Stretcher

6. Flight Structures Ltd
Hamilton
Transport Incubator
The transport incubator makes an ideal case study to cover the certification issues common to medical equipment fits

7. Trolley Base for Aircraft Interface
Flight Structures Ltd
Hamilton
Ventilator
Monitor
Batteries
Incubator
Oxygen Cylinder
Air Cylinder
Trolley Base for Aircraft Interface
Syringe Driver
Humidifier
Vacuum

8. Certification Points Patient restraint Restraint of items of mass
Flight Structures Ltd
Hamilton
Certification Points
Patient restraint
Restraint of items of mass
Component fire resistance
Electrical system safety and function
Electromagnetic compatibility

9. CERTIFICATION GUIDANCE
Flight Structures Ltd
Hamilton
CERTIFICATION GUIDANCE
FAA AC135-14A EMS HELICOPTERS
FAA AC EMS AIRCRAFT
CAANZ AC43-14 AVIONIC SYSTEMS
CAA ACU STAFF

10. Flight Structures Ltd
Hamilton
Patient Restraint
Require full restraint harness with additional straps to support the lower body
Applicable Design Standards are:
TSO-C114 - Torso Restraint Systems
TSO-C22G - Safety Belts

11. Items of Mass Restraint
Flight Structures Ltd
Hamilton
Items of Mass Restraint
Restraint of mass is not insignificant
A typical incubator assembly has a certified weight in the order of 140 kgs.
Combined with an operational requirement for a simple stretcher latching system.
Most aircraft make use of a locating frame for the stretcher which may be supplemented through the use of tie-down straps.

12. Flight Structures Ltd
Hamilton

13. Flight Structures Ltd
Hamilton

14. Flight Structures Ltd
Hamilton
Fire Resistance
The certification basis for the medical transport aircraft typically requires all materials to be “Flame-Resistant” or “Flash-Resistant”.
This requirement is common to the medical certification requirements
All other non-metallic components are either aircraft specification or tested to demonstrate compliance

15. Flight Structures Ltd
Hamilton
System Safety
Power is distributed from the medical batteries to the medical equipment through inverters and converters as required.
All electrical wiring, circuit breakers, switches, etc must comply with the appropriate aircraft standards.
A functional check of the electrical system is carried out to ensure that all the components operate correctly and remain within manufacturers recommended temperatures.

16. Electromagnetic Compatibility
Flight Structures Ltd
Hamilton
Electromagnetic Compatibility
Electromagnetic Compatibility can be the most challenging certification requirement to meet, due in part to final checks that are required to be accomplished with the medical system installed into the aircraft.
Several common medical components are known to produce electromagnetic interference:
Incubator heating controllers
Switch-mode power supplies commonly used in AC to DC voltage converters
DC to AC power inverters

17. EMC Compliance The paths available to demonstrate compliance.
Flight Structures Ltd
Hamilton
EMC Compliance
The paths available to demonstrate compliance.
Obtain DO160 Section 21 Category M Certification.
For IFR approval flight testing may be required.
For VFR approval ground testing for NAV/COM radio interference is required.

18. Flight Structures Ltd
Hamilton
EMC Compliance
A large proportion of the medical components comply with ISO EMC standard which is less stringent than the DO160 requirements, with compliance making the equipment acceptable for use during the cruise flight phases on an IFR rated aircraft without the need for flight testing.
All equipment installations undergo ground EMC checks following the guidance from CAA AC43-14 and FAA AC B to ensure that there is no radiated or conducted interference with the aircraft navigation and communication systems.

19. Flight Structures Ltd
Hamilton
Summary
Equipment fits designed and approved for use in intensive care units and ambulances require attention to be approved for use on aircraft.
In some cases medical equipment do not meet the aircraft standards and require upgrades to show compliance with the aircraft standards.

20. Flight Structures Ltd
Hamilton
QUESTIONS

21. Electrical Equipment Batteries – Deep Cycle Sealed Lead Acid (SLA)
Flight Structures Ltd
Hamilton
Electrical Equipment
The majority of the electrical medical equipment is powered by individual internal rechargeable batteries.
In support of longer duration patient transport missions supplemental power supplies to the medical equipment internal batteries is required.
The additional power may be supplied from a combination of aircraft power and the following components:
Batteries – Deep Cycle Sealed Lead Acid (SLA)
Voltage converters – 12/24 VDC  18 VDC VDC  24 VDC VDC  12 VDC
Power converters – 12/24 VDC  240 VAC
Battery charging from 12VDC, 24VDC, 115VAC, or 240VAC aircraft power supply.

22. Flight Structures Ltd
Hamilton

23. Flight Structures Ltd
Hamilton