Medical Gas Supply Systems

Medical gas supply systems — in.AIR and in.VAC

Complete sources supplying the installation — medical compressed air (in.AIR) and medical vacuum (in.VAC). Class IIa medical devices compliant with MDR 2017/745, with CE marking.

Legal requirements

The medical gas supply system must be a medical device bearing the CE marking

Standard PN-EN ISO 7396-1:2016 (point K.2.2) indicates that if medical gases are produced on site, the equipment used for their production should hold certificates confirming that it is suitable for its intended use. In the European Union, the appropriate approval is CE marking notified body — originally within the scope of Directive 93/42/EWG, currently of the Regulation MDR 2017/745.

In practice, this means that medical gas supply systems — the medical air plant, the medical vacuum plant, the oxygen supply, the medical air mixing system or the source of air for driving surgical instruments — must have the appropriate conformity documentation and CE marking. Technical efficiency of the device alone is not enough — the source must be intended for medical use and documented as a medical device.

That is why sources in.AIR i in.VAC are supplied as separate medical devices — each with its own declaration of conformity and CE marking.

Based on: „Medical gases in practice. Volume 1", sect. 8.2. Order the guide

Regulatory status of in.AIR and in.VAC

  • Medical device class IIa
  • Regulation (EU) 2017/745 (MDR)
  • Separate declaration of conformity for each source
  • Production INMED S.A.
ManufacturerINMED S.A. — manufacturer
CE certificate number TNP/MDR/0038/4999/2025
Download the CE certificate (PDF) VAT rate 8%
Compressed medical air

in.AIR — medical air plant

A complete certified medical air plant: compressors, drying down to a dew point of −70°C, multi-stage filtration, 5 / 8 bar pressure regulators as well as continuous monitoring of the dew point and CO level. Available in configurations from 1 to 3 compressors (AMC 2 – AMC 132). In accordance with the ISO 7396-1 standard, each compressor independently provides the full design flow rate — the source's capacity corresponds to the capacity of a single compressor, while the remaining ones serve as redundancy.

Device construction diagram

Diagram of the construction of the in.AIR medical air plant — compressors, separator, air receiver, dryers, filters, regulators, monitoring

Diagram of the in.AIR system construction (Operating manual, sec. 6.1).

Description of diagram elements

1Air compressors — sized to the facility's demand, with a reserve for dryer regeneration.
2Cyclone condensate separator — separates liquid from compressed air.
3Pressure vessel — stabilises the pressure and buffers compressor operation.
4Dryer assembly — refrigerant (~3°C) and adsorption (~−70°C).
5Condensate drain (electronic) — automatic drainage.
6Filter assembly — preliminary, fine and with activated carbon.
7Pressure regulators (double set) — 5 bar (air), 8 bar (surgical tools).
8Dew point and CO monitor — continuous air quality control.
9Sampling point — for analyses in accordance with the pharmacopoeia.
10Connection of the third reserve source of supply — supply from an alternative zone.
11Outlet connection — for the pipeline installation in the hospital.
12Master controller (Master / Control) — balances compressor operation.
13Water/oil separator — safe condensate drainage.

Configuration selection

ISO 7396-1 Eur. Pharmacopoeia Class IIa · CE
Download the in.AIR catalogue (PDF)
Medical vacuum

in.VAC — medical vacuum plant

Complete medical vacuum plant in an integrated enclosure: redundant vacuum pumps, balancing tank, antibacterial filtration and a control cabinet with phase-failure protection and a 4.3″ LCD display.

Device construction diagram

Diagram of the construction of an in.VAC medical vacuum plant — frame, control cabinet, display, vacuum pumps, antibacterial filters, balancing tank

Diagram of the in.VAC plant construction (Operating manual, sec. 6.1).

Description of diagram elements

1Steel frame — supporting structure (powder-coated / galvanised profiles), vibration damping.
2Control cabinet — overload, short-circuit and phase-failure protection.
34.3″ LCD display — visualisation of pressure, pump states, alarms and history.
4Vacuum pumps — side channel, rotary vane, claw or screw type (depending on configuration).
5Antibacterial filters — biological protection of the installation.
6Buffer tank — vacuum stabilisation in the system.

Model selection

ISO 7396-1 Modbus / BMS Class IIa · CE
Download the in.VAC catalogue (PDF)

Frequently asked questions — medical gas supply systems

What is a medical air plant (compressed medical air unit)?

in.AIR is a complete medical air plant — a compressed medical air unit with compressors, drying to a −70°C dew point, multi-stage filtration and monitoring. A supply system compliant with ISO 7396-1, a Class IIa medical device.

What is a medical vacuum plant (medical vacuum pump)?

in.VAC is a medical vacuum plant with redundant vacuum pumps, a buffer tank and antibacterial filtration — a medical vacuum supply system compliant with ISO 7396-1, a Class IIa medical device.

How does in.AIR differ from in.VAC?

in.AIR produces compressed medical air using compressors, while in.VAC produces medical vacuum using vacuum pumps. Both are medical gas supply systems for the pipeline installation.

How do I size the capacity of a medical vacuum or compressed air installation?

In accordance with ISO 7396-1, the supply system is sized so that a single compressor or vacuum pump provides the full design flow, while the remaining units serve as redundancy. Use the online sizing tool above.

Are the medical vacuum plant and the medical air plant medical devices?

Yes. in.AIR and in.VAC are Class IIa medical devices under MDR 2017/745, have separate declarations of conformity and CE marking, and their sale is subject to the 8% VAT rate.

Who manufactures and deploys the in.AIR and in.VAC supply systems?

The supply systems are manufactured by INMED S.A. Medpipe designs, sizes and deploys medical gas installations — medical air plants and medical vacuum plants — throughout Poland.

Manufacturer

in.AIR and in.VAC supply systems — manufactured by INMED S.A.

INMED S.A., ul. Kwiatowa 32a, 55-330 Krępice. Class IIa medical devices, MDR 2017/745, CE marking (no. TNP/MDR/0038/4999/2025), EUDAMED registration. Medpipe selects, designs, installs, commissions and services sources as part of complete medical gas installations.