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Are you using the right Air Plant for medical purpose?

Air Compressors find a wide variety of applications in various sectors like Aerospace, Automotive, Chemical Manufacturing, Electronics, Food and Beverage, General Manufacturing, Glass Manufacturing, Hospitals, Laboratories, Medical, Mining, Pharmaceuticals, Plastics, Power Generation, and many more. In the medical industry air compressors are used to produce air for breathing purposes, in neo natal intensive care units, for gas generation, to run surgical tools and aspirators and much more. Uninterrupted supply of quality medical air is key to ensure patient safety. This is the basis of design, manufacturing, installation and maintenance of Medical Air Plants in a health care facility.

What makes air “medical”?

medical-air-plant
Medical Air Plants are classified as medical devices hence should be designed and manufactured as per ISO 13485- Quality Management Standard for Medical Devices. Since Medical air supply is critical for patient safety the air plants should comply with the following legislations and international standards: • Medical Devices Directive 93/42/EEC (CE Marking) • Pharmacopoeia requirements • EN ISO 7396-1 (Europe) • HTM 0201 or HTM 2022 (UK) • NFPA 99 (USA)

The Medical Air Plant, should, as a minimum, have the following features:

• A mandatory comprehensive risk analysis. • The software developed should comply with EN62304, which is the standard that describes the medical software development process. The software has to be thoroughly tested and a test report of the latest software version should always be available. • The compressor should be a part of the technical file (MDMF) for the air plant. • The compressors must have an Automatic-Restart-After-Voltage-Failure (ARAVF) feature. • When the risk analyses reveals there are high risks involved, then measures need to be taken to lower that risk. • Finally, there should also be a specific test procedure and the compressors should be tested as a complete air plant, to ensure all components can work well together without any flaws.

If the user is following the HTM 02-01 standard, which is the most predominantly used standard in this part of the world, there are additional stringent requirements for the medical air plant listed as below: 

  • A main switch and amp meter are necessary. 
  • The HTM units are to be fitted with a pressure switch for the Fail-To-Go-On-Load (FTGOL) alarm. The alarm will be triggered when the unit is not delivering pressure to the system after a start command has been given. 
  • A temperature sensor is necessary to track the outlet temperature of the after cooler. 
  • A LAN/local switch is required for intuitive and easy switching between local mode or ES control. 
  • Each compressor should have an individual control box, an isolator interlocked with the covers, an industrial grade amp meter and a “total hours” counter. 
  • In addition, the plant should have control functions, communicated to hospital via alarms, such as: Control circuit failure; Motor trip; After cooler temperature high;  Compressor temperature high; Compressor failed-to-go-on-load; Activation of other safety devices supplied by the manufacturers.
Features of medical air compressor

Check your system today whether you installed the right Medical Air Plant, or contact our Specialist for more information and support via email: medicalgas.acsme@beaconmedaes.com.

Medical air systems