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Certification of Transport Medical Equipment. Ensuring Patient Safety and Wellbeing While in the Air. Chris Raynes Senior Design and Certification Engineer. Introduction.

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certification of transport medical equipment

Certification of Transport Medical Equipment

Ensuring Patient Safety and Wellbeing While in the Air

Chris Raynes

Senior Design and Certification Engineer

introduction
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

medi vac operation
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
medical transport equipment certification
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.

medical equipment
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
transport incubator
Transport Incubator

The transport incubator makes an ideal case study to cover the certification issues common to medical equipment fits

slide7

Ventilator

Monitor

Batteries

Incubator

Oxygen Cylinder

Air Cylinder

Trolley Base for Aircraft Interface

Syringe Driver

Humidifier

Vacuum

certification points
Certification Points
  • Patient restraint
  • Restraint of items of mass
  • Component fire resistance
  • Electrical system safety and function
  • Electromagnetic compatibility
certification guidance
CERTIFICATION GUIDANCE
  • FAA AC135-14A EMS HELICOPTERS
  • FAA AC135-15 EMS AIRCRAFT
  • CAANZ AC43-14 AVIONIC SYSTEMS
  • CAA ACU STAFF
patient restraint
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
items of mass restraint
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.
fire resistance
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
system safety
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.
electromagnetic compatibility
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
emc compliance
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.
emc compliance18
EMC Compliance
  • A large proportion of the medical components comply with ISO 60601-1-2 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 AC43.13-2B to ensure that there is no radiated or conducted interference with the aircraft navigation and communication systems.
summary
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.
electrical equipment
Batteries – Deep Cycle Sealed Lead Acid (SLA)

Voltage converters – 12/24 VDC  18 VDC - 12 VDC  24 VDC - 24 VDC  12 VDC

Power converters – 12/24 VDC  240 VAC

Battery charging from 12VDC, 24VDC, 115VAC, or 240VAC aircraft power supply.

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: