Technical documentation

Design of medical gas installations

A medical gas installation is a class IIb medical device, so the design does not end with drawings. We model in BIM in accordance with PN-EN ISO 7396-1 and 7396-2, and the result is a complete set of documentation: the technical documentation of the device and the operational documentation for the hospital.

Scope of the design

A device design, not merely a pipeline design

A medical gas pipeline system falls under Regulation MDR 2017/745 and is classified as a class IIb device. The consequence is a very practical one: alongside the installation documentation, technical documentation of the device must be produced, because without it neither conformity assessment nor CE marking of the installation is possible.

That is why we run the design in two parallel layers. The first is the installation layer: routes, diameters, terminal units and medical supply units, backed by hydraulic calculations with diversity factors. The second is the device layer — the technical documentation required for class IIb, in which the regulation also requires risk management to be documented.

The Operational Management Documentation is prepared separately. It costs least when it is produced together with the design, while all the installation data is still to hand. For an installation that already exists, with no documentation retained, the starting point is an as-built survey — its results become the basis of the OMD.

When an installation carries CE marking and when it is merely an assembly of devices is explained in our article: does a medical gas installation have CE marking. What the operational documentation contains: Operational Management Documentation. For installations without documentation: as-built survey and audit.

What the client receives

  • concept design and detailed design to PN-EN ISO 7396-1
  • hydraulic calculations with diversity factors
  • functional schematics and BIM/Revit drawings
  • material and equipment specifications
  • technical documentation of the class IIb device
  • Operational Management Documentation
BIM

A clash is cheaper to find in the model than above the ceiling

We design in BIM in the Autodesk Revit environment. The space above the suspended ceiling in a procedure ward is one of the most densely occupied in the entire hospital: ventilation, cooling, cable routes, sprinklers and medical gas pipelines all compete for the same centimetres.

In a spatial model a clash is visible before anyone orders the pipe — at that point the drawing is corrected. The same clash found on site means rerouting, repeat leak tests and a delay to the date the ceiling is closed.

The model also gives something a flat drawing cannot: pipeline lengths and diameters follow from the geometry of the actual route. This is the basis for the hydraulic calculations with diversity factors that go into the design documentation.

Why acceptance testing of the installation must precede closing of the ceiling: acceptance tests before the ceiling is closed.

Normative basis

  • PN-EN ISO 7396-1 — pipeline systems for compressed medical gases and vacuum
  • PN-EN ISO 7396-2 — anaesthetic gas scavenging disposal systems
  • MDR 2017/745 — class IIb medical device
  • the British HTM 02-01 and the French FDS

Four decisions that are settled at the design stage

None of them can be changed later without intervening in the completed installation

Demand and diameters

Flow is calculated for simultaneous demand, not for the sum of the terminal units. An undersized pipeline only becomes apparent once the ward is working at full occupancy — that is, at the worst possible moment.

Supply systems and reserve

The selection of supply systems and routes belongs to the concept design. It settles how many sources run, how many stand in reserve, and how long the hospital will hold supply once one line is cut off.

Oxygen reserve and continuity of supply

Zoning and isolation

The division into zones determines how large a part of the hospital has to be shut down in order to carry out a repair or an extension. Badly positioned isolation valves can block an entire subsequent refurbishment.

Reserve supply for the ICU

Signalling and alarms

The standard specifies what is to be signalled and where. The design settles who will actually see an alarm at three in the morning — and that is a matter of organisation, not of wiring alone.

Medical gas installation alarms

Experience

Fifteen years of documentation for hospitals

For more than fifteen years we have been producing documentation and supervising medical gas installations, taking part in the largest hospital projects in Poland. Our design experience is confirmed by our involvement in standardisation as well: we have been appointed to Komitet Techniczny PKN nr 284 for mechanical medical equipment, instruments and devices.

Our specialists lecture at technical and medical universities, co-author industry publications and act as court experts and as experts on the security of critical infrastructure facilities. The same knowledge that goes into expert opinions and lectures goes into our designs.

The full list of completed projects is shown on the map: Medpipe projects.

Selected designs

  • Szpital Uniwersytecki Kraków-Prokocim
  • Wielkopolskie Centrum Zdrowia Dziecka w Poznaniu
  • SPWSZ w Szczecinie, Oddział Nefrologii

Frequently asked questions about design

What does the medical gas installation design process look like?

The process includes: (1) analysis of the facility's requirements — type of institution, number and types of supply points, zone requirements; (2) a concept design with the selection of sources and routes; (3) a detailed design in BIM technology (Autodesk Revit) in accordance with PN-EN ISO 7396-1; (4) preparation of operational management documentation (DZE); (5) technical acceptance and post-installation validation.

What documents does a medical gas installation design contain?

The complete design documentation includes: a concept and detailed design according to PN-EN ISO 7396-1, hydraulic calculations (including simultaneity factors), functional diagrams and BIM/Revit drawings, specifications of materials and equipment, operational management documentation (DZE) as well as — for class IIb medical devices according to MDR 2017/745 — the required technical documentation.

Is a medical gas installation design subject to the MDR 2017/745 regulation?

Yes. Pipeline medical gas systems are classified as class IIb medical devices in accordance with the MDR 2017/745 Regulation. The design and execution of the installation must meet the essential requirements of a medical device. Medpipe takes these requirements into account at every stage of the project and issues technical opinions regarding conformity.

How long does a medical gas installation project take?

The lead time depends on the scale of the facility. A project for a small establishment usually takes 2–4 weeks; a full design of a hospital medical gas system — 6–12 weeks. We set the exact schedule individually after analysing the requirements of the investment.

Why design in BIM when a floor plan and a schematic would do?

Because a medical gas installation shares the space above the ceiling with ventilation, cooling, cable routes and sprinklers. A spatial model in Autodesk Revit shows clashes at the design stage — at that point the drawing is corrected, rather than a finished ceiling being cut open. Pipeline lengths and diameters also follow from the model geometry, so the hydraulic calculations are based on the actual route.

Does the design cover the selection of supply systems?

Yes — the selection of supply systems and routes belongs to the concept design. It also settles how the reserve supply is arranged, because that determines whether the hospital keeps its oxygen supply during a failure or when one of the lines is cut off.

How to word the requirements in the specification so that tenders can be compared: tender requirements for medical gases.

Quotation

Tell us about the project and we will prepare the scope

To start the conversation we need the project stage, the number of wards and whether the installation is being built from scratch or extended in a hospital that remains in operation. We design throughout Poland.