Medical Vacuum Station – Compliant with TS EN ISO 7396-1 Standard

TURKISH STANDARD TS EN ISO 7396-1

5.7 Vacuum Supply Systems

5.7.1 A vacuum supply system shall consist of at least three supply sources, one receiver (vacuum tank), two parallel bacterial filters, and one discharge trap. A supply source typically includes one or more vacuum pumps.

5.7.2 Where the three supply sources consist of three separate pumps, each pump shall be capable of supplying the system’s designed flow rate in order to ensure continuity of supply.

5.7.3 If the vacuum supply system consists of more than three pumps that can be switched between different supply sources to ensure sufficient capacity, then during maintenance of any pump or system component and under any single fault condition of the system (e.g., control system failure), the remaining pumps and components shall be capable of supplying the system’s designed flow rate to ensure continuous supply.

5.7.4 Each pump shall have a control circuit arranged so that shutting down or failure of one pump does not affect the operation of the others. The control system shall be arranged so that all pumps supply the system either sequentially or simultaneously. This requirement shall be met under both normal and single fault conditions.

5.7.5 All vacuum supply systems shall comply with Clause 5.2.2.1. All supply sources shall be connected to the emergency power supply. Receivers shall comply with applicable regional and national standards.

5.7.7 Each receiver shall be connected to isolation valve(s) for maintenance, a drain valve, and a vacuum gauge. If only one receiver and one discharge trap are installed, bypass arrangements shall be provided.

5.7.8 Gas exhaust outlets from vacuum pumps shall be discharged outdoors and provided with means to prevent the entry of insects, contamination, and water. Exhaust outlets shall be positioned away from air intakes, doors, windows, or other building openings. The potential effects of prevailing winds at the exhaust outlet(s) shall be considered.

5.7.9 The exhaust line shall be provided with a drainage facility at its lowest point.

5.7.10 Where necessary, means shall be provided to prevent transmission of vibration from vacuum pumps to the pipeline.

5.7.11 Each bacterial filter shall be capable of passing the system’s designed flow rate under normal operating conditions.

5.7.12 Vacuum supply systems compliant with this standard shall not be used as AGS power devices (ISO 7396-2 [5]).

5.2.2 Continuity of Supply

5.2.2.1 Supply systems for compressed medical gases and vacuum shall be designed to ensure that, under normal and single fault conditions, the system’s designed flow rate is maintained at the distribution pressure specified in Clause 7.2.

Note – Loss of electrical power supply or water supply constitutes a single fault condition. Failure of control equipment is also considered a single fault condition.

To achieve this:

a) Compressed medical gas and vacuum supply systems shall consist of at least three supply sources (e.g., primary, secondary, and reserve supply sources).
b) Pipeline installation and routing shall reduce the risk of mechanical damage to an acceptable level.
c) Complete pipeline failure is not considered a single fault condition but a catastrophic event and shall be managed according to emergency procedures (Annex G).

7.2 Distribution Pressure

Unless otherwise stated, pressures specified in this standard are expressed as gauge pressure (atmospheric pressure = 0).

7.2.4 (Vacuum Systems)
For vacuum systems, the pressure at any terminal unit shall not exceed an absolute pressure of 60 kPa when the system operates at its designed flow rate and with a flow of 25 L/min at the terminal unit.

7.2.5 & 7.2.6 (Overpressure Protection)
Appropriate means (e.g., pressure relief valves) shall be provided to ensure pressure limits are not exceeded in the event of a single fault condition in any pressure regulator installed within the system. Safety discs shall not be used for this purpose. If fitted, pressure relief valves shall comply with Clause 5.2.6.

Manufacturers shall provide appropriate documentation and declarations of compliance. Regional, national, or international standards (e.g., ISO 4126-1) regarding pressure relief devices shall be observed.