The complete guide CE 1639 · MDR Class IIb

Medical vacuum plants for hospitals: the complete guide.

How oil-free medical vacuum plants and AGSS systems serve hospital pipelines under EN ISO 7396-1, why every operating theatre needs both, and how to specify the right plant for your facility. Engineered in Lisbon since 1981, deployed in 80+ countries.

ULTRAVAC medical vacuum plant by Ultra Controlo
Pipeline standard
EN ISO7396-1
Hospital medical gas pipelines
Vacuum level
400mmHg
Minimum required at terminal units
Pump technology
Oilfree
Rotary vane, claw, or screw pumps
Redundancy
N+1
Duplex configurations standard
Countries deployed
80+
Hospitals, ministries of health, NGOs
What is a medical vacuum plant

Negative pressure, delivered to every clinical area.

Medical vacuum is the fourth core medical gas pipeline service in any modern hospital, alongside oxygen, medical air, and AGSS. It powers surgical suction, bedside aspiration, fluid drainage, and clinical waste handling 24 hours a day. Without reliable medical vacuum, no operating theatre, ICU bed, or emergency department can function.

Medical vacuum explained

From bedside outlet to safe exhaust.

A complete medical vacuum plant uses oil-free or oil-sealed vacuum pumps to maintain continuous negative pressure throughout the hospital pipeline. Aspirated fluids are collected in jars at the point of use; the gas component flows through bacterial filters before being exhausted safely outside the building.

A medical vacuum plant is a complete medical-device system that generates and maintains negative pressure throughout a hospital's vacuum pipeline. ULTRAVAC by Ultra Controlo is certified as a Class IIb medical device under MDR (EU) 2017/745.

The four hospital vacuum services

Hospitals use vacuum for distinctly different clinical purposes. The pipeline must be sized to handle peak simultaneous demand across all four:

Vacuum applications · hospital pipeline
4 services
Surgical suctionOperating theatres · high-flow continuous
Bedside aspirationICU, general wards · intermittent low-flow
DrainageWound drainage, chest tubes · sustained
Dental aspirationULTRAVAC DENTAL · with amalgam separation
How a medical vacuum plant works

Four functional stages, one continuous pipeline service.

Medical vacuum plants are integrated systems. Four functional stages must work together continuously to maintain pipeline vacuum and handle aspirated material safely.

EN ISO 7396-1 compliant
01

Vacuum generation

Oil-free or oil-sealed vacuum pumps create and maintain negative pressure in the pipeline. ULTRAVAC plants use proven rotary vane, claw, or screw vacuum pump technologies sized to actual hospital demand. Pumps cycle on demand based on pipeline pressure feedback.

Oil-free options
02

Vacuum reservoir

A vacuum reservoir buffers consumption peaks and maintains stable pipeline pressure during rapid demand changes. Reservoir sizing is critical: too small causes pressure swings, too large wastes energy. ULTRAVAC reservoirs are sized specifically for each facility's profile.

500–700 mmHg pipeline
03

Bacterial filtration of exhaust

Vacuum pump exhaust contains aerosolised body fluids and gases that must be filtered before venting. ULTRAVAC plants include bacterial filtration on the exhaust line plus a safe vent path outside the building. AGSS exhaust is always vented separately.

Bacterial · external vent
04

Continuous monitoring & auto-failover

Onboard sensors continuously track pipeline vacuum level, pump status, and reservoir pressure. EN ISO 7396-1 mandates auto-failover to a backup pump on any out-of-spec parameter. Remote telemetry sends alarms to biomedical engineering staff and Ultra Controlo's UltraCare service centre.

24/7 remote diagnostics
Why on-site vacuum

Four reasons every hospital needs its own vacuum plant.

Unlike oxygen and medical air, no real alternative exists for medical vacuum. Every hospital with surgical theatres, ICU beds, or inpatient wards must operate a dedicated vacuum plant. The question is not whether to install one, but how to specify it for reliability and lifecycle cost.

Reason 01

Continuous demand across all critical areas

Every operating theatre, ICU bed, emergency room bay, and recovery position requires reliable vacuum. A medium hospital can have 50 to 200 active vacuum outlets, with peak simultaneous demand during morning surgical and admission rounds.

100–250 m³/h
typical mid-size hospital demand
Reason 02

Loss of vacuum is a Class A clinical event

Surgical procedures cannot proceed without working suction. EN ISO 7396-1 mandates N+1 redundancy for hospital vacuum plants. Most installations use duplex or triplex pump configurations with auto-failover, allowing maintenance without service interruption.

N+1
redundancy required by EN ISO 7396-1
Reason 03

Exhaust must be filtered and vented safely

Vacuum exhaust contains aerosolised body fluids and respiratory gases, which is a clinical and infection-control hazard if not managed correctly. Bacterial filtration on the exhaust line and external venting outside the building are mandatory under modern hospital design standards.

External vent
bacterial filtered exhaust
Reason 04

Compliance built in by design

ULTRAVAC plants are complete medical devices, not assembled from generic industrial components. Every plant is certified CE 1639 under MDR (EU) 2017/745, manufactured under ISO 13485:2016 quality system, and delivered with full EN ISO 7396-1 documentation and commissioning support.

CE 1639
MDR Class IIb · ISO 13485
Vacuum supply options compared

Central vacuum, portable units, and shared industrial pumps, compared.

Three approaches exist for hospital vacuum supply. Only one delivers compliant, continuous service at the scale modern hospitals require.

Method 1
Portable suction units
Bedside electric suction pumps
Method 2
Shared industrial vacuum
Repurposed industrial pump + filtration
Coverage
Single bedside only
Limited zones
EN ISO 7396-1 compliance
Backup only
Not compliant
Continuity risk
Per-unit failure point
Single point of failure
Exhaust handling
Internal release
Variable
Vacuum level at terminal
Variable per unit
Inconsistent at distance
Manufacturer accountability
Per-unit warranty
Distributed
Best for
Single-room emergency backup
Not recommended
ULTRAVAC medical vacuum plant configuration
ULTRAVAC® Complete medical device
The reference medical vacuum plant

ULTRAVAC. The complete medical vacuum solution.

ULTRAVAC is a complete medical vacuum plant certified as a Class IIb medical device under MDR (EU) 2017/745. Engineered and manufactured in Lisbon since 1981. Available in standard, claw, low-noise, and dental configurations to match any hospital application.

Vacuum level
500–700 mmHg
Stable pipeline pressure
Certification
CE 1639
MDR Class IIb · ISO 13485:2016
Pump technology
Multiple options
Rotary vane, claw, or screw
Exhaust
Bacterial filtered
External venting compliant
AGSS · ULTRASEG

Anaesthetic gas scavenging: a separate, dedicated system.

Every operating theatre using inhaled anaesthetic agents (sevoflurane, isoflurane, desflurane, nitrous oxide) needs a dedicated Anaesthetic Gas Scavenging System (AGSS). AGSS captures waste anaesthetic gases from the breathing circuit and exhausts them safely outside the building, protecting surgical staff from chronic occupational exposure.

ULTRASEG is Ultra Controlo's dedicated AGSS solution. It runs as a separate pipeline from medical vacuum and is governed by EN ISO 7396-2, the standard specifically covering anaesthetic gas scavenging systems.

Critical: AGSS exhaust must never combine with general medical vacuum exhaust. Mixing the two systems risks contamination and creates compliance violations under EN ISO 7396-2. ULTRASEG is supplied as an entirely separate plant with independent piping, pumps, and exhaust paths.
Request ULTRASEG specification
ULTRASEG anaesthetic gas scavenging system by Ultra Controlo
ULTRASEG® AGSS dedicated plant
Continuous occupational protectionCaptures waste anaesthetic gases at source. Required wherever inhaled agents are used.
EN ISO 7396-2 compliantThe dedicated standard for anaesthetic gas scavenging in healthcare facilities.
Separate pipeline + exhaustIndependent of medical vacuum. Direct external venting compliant with safety standards.
CE 1639 medical deviceSame regulatory framework as ULTRAVAC. MDR Class IIb, ISO 13485:2016.
Sized to theatre countCapacity matched to number of operating theatres and average anaesthesia hours per day.
Inside the system

Engineered to medical-device standards. Built to last.

Every ULTRAVAC plant is assembled in our Lisbon facility under ISO 13485:2016 quality control. Vacuum pumps, reservoirs, bacterial filtration, monitoring instrumentation, and EN ISO 7396-1 control panels all integrated into a single CE 1639 certified medical device.

  • Multiple pump technologiesRotary vane, claw, and screw vacuum pumps available. Selected for hospital duty cycle and acoustic profile.
  • Bacterial filtration of exhaustMedical-grade bacterial filters on exhaust line plus external venting outside the building.
  • Redundant monitoringContinuous vacuum level, pump cycle, and reservoir pressure monitoring. Auto-failover on out-of-spec parameters.
  • Remote diagnostics readyOptional remote telemetry for predictive maintenance and 24/7 oversight by Ultra Controlo engineers worldwide.
ULTRAVAC medical vacuum plant close-up detail
Real-world deployments

ULTRAVAC in service. Hospitals on five continents.

Real medical vacuum plants delivered, commissioned, and supported by Ultra Controlo. Ministries of health, UN agencies, and NGO partners across Africa, the Middle East, Latin America, and Southeast Asia.

CV
2024
Cabo Verde · Praia

Hospital Agostinho Neto regional referral hospital

A complete medical gas pipeline system serving this 220-bed regional referral hospital, including ULTRAVAC central vacuum plant alongside ULTRAOX oxygen and ULTRAAR medical air. Full pipeline distribution to all critical care areas.

Beds
220
Pipeline
EN ISO 7396-1
Ministry of Health partnership
ML
2026
Mali · Bamako + Kayes

Two complete medical gas plants commissioned

Two complete medical gas pipelines including ULTRAVAC vacuum plants at Hôpital Dermatologie de Bamako and a Ministerial inauguration in Kayes. Vacuum coverage for surgical theatres, ICU, and inpatient wards.

Plants
2 duplex
Inauguration
Ministerial
Ministry of Health Mali
YE
2025
Yemen · Zabeed

Zabeed General Hospital medical gas pipeline

Complete medical vacuum plant integrated with the wider medical gas pipeline including ULTRAOX 180D ST oxygen generation. Designed for high-demand regional hospital operations under challenging conditions.

Configuration
Duplex
Coverage
All wards
Humanitarian deployment
AO
2026
Angola · Benguela

UNDP & Global Fund national programme

Complete medical gas systems including ULTRAVAC vacuum plants at Hospital de Benguela under a national UNDP and Global Fund programme covering up to 8 hospitals nationwide. Complete supply, installation, training, and lifecycle support.

Hospitals
Up to 8
Donor
UNDP + GF
UNDP · Global Fund
PE
Active
Peru · Andean clinic

High-altitude medical gas installation

A complete medical gas system including vacuum services operating at high altitude in the Peruvian Andes, supplying critical care and surgical capability to remote mountain populations. Demonstrates ULTRAVAC viability across extreme environments.

Environment
Andean
Altitude
High
Latin America deployment
BD
2024
Bangladesh · Hospital project

Complete pipeline including vacuum services

A flagship hospital project including ULTRAAR medical air duplex (2×52 Nm³/h) and full ULTRAVAC vacuum plant commissioned together. Demonstrates Ultra Controlo's capability as single source for full medical gas pipeline systems.

Vacuum
Duplex
Pressure
10 bar
Single-source pipeline
Sizing & specification

How to size a medical vacuum plant for your hospital.

Choosing the right plant requires understanding your facility's actual and projected vacuum demand. Five factors drive the right specification.

Ultra Controlo's engineering team provides free pre-project site assessments and system sizing consultations as part of every project enquiry.

Request free sizing assessment
01

Outlet count and diversity factor

Sum of all bedside outlets is misleading. Peak simultaneous use matters. Diversity factors of 25 to 40 percent for general wards, 50 to 70 percent for ICU, and 80 to 95 percent for operating theatres are typical.

02

Surgical activity drives total demand

A facility with 4 active operating theatres can generate more vacuum demand than a 100-bed general ward hospital. Surgical and ICU mix dominates total m³/hour calculations.

03

Pipeline vacuum standard

EN ISO 7396-3 requires minimum 400 mmHg at every terminal. Hospital pipelines typically maintain 500 to 700 mmHg at the plant to ensure adequate vacuum at the most distant outlets even at peak load.

04

N+1 redundancy required

EN ISO 7396-1 mandates a backup pump source. Duplex configurations with two independent vacuum pumps are standard, allowing one pump to undergo maintenance while the other maintains pipeline service uninterrupted.

05

AGSS as a separate parallel system

If your facility uses inhaled anaesthetic agents in any operating theatre, ULTRASEG (AGSS) must be specified as a separate parallel plant. AGSS exhaust never combines with general medical vacuum exhaust under EN ISO 7396-2.

Standards & certification

The compliance stack required for hospital medical vacuum.

A hospital medical vacuum plant must satisfy multiple international standards. ULTRAVAC and ULTRASEG hold the complete medical-device compliance stack.

CE 1639

MDR (EU) 2017/745 Class IIb

Medical device certification under the European Medical Device Regulation. Required for hospital medical vacuum and AGSS plants in the EU and aligned markets.

ISO 13485:2016

Manufacturer quality system

Quality management system certification for medical device manufacturers. Governs design, production, and post-market surveillance throughout the device lifecycle.

EN ISO 7396-1

Medical gas pipeline systems

European standard for medical gas pipeline systems, including vacuum. Specifies design, installation, performance, documentation, testing, and commissioning of compressed and vacuum medical gas pipelines.

EN ISO 7396-2

Anaesthetic gas scavenging

Dedicated standard for AGSS (Anaesthetic Gas Scavenging Systems) in healthcare facilities. Required wherever inhaled anaesthetic agents are used. ULTRASEG is fully compliant.

Frequently asked questions

Common questions about medical vacuum for hospitals.

Answers from our engineering team to the questions hospital procurement, biomedical engineers, and ministries of health most often ask.

What is a medical vacuum plant?

A medical vacuum plant is a complete medical-device system that generates and maintains negative pressure throughout a hospital's vacuum pipeline. It is used for surgical and bedside suction, fluid removal, drainage, and clinical aspiration.

ULTRAVAC by Ultra Controlo is a complete medical vacuum plant certified as a Class IIb medical device.

What clinical applications use medical vacuum?

Medical vacuum is used in surgical suction during operations, bedside aspiration in ICU and general wards, fluid drainage from wounds and chest tubes, dental procedures, gastric suction, and laboratory specimen handling.

It is one of the four core medical gas pipeline services alongside oxygen, medical air, and AGSS.

What is the difference between medical vacuum and AGSS?

Medical vacuum (ULTRAVAC) provides general clinical suction across the hospital.

AGSS (Anaesthetic Gas Scavenging System, ULTRASEG) is a separate dedicated system that captures waste anaesthetic gases from operating theatre breathing circuits and exhausts them safely outside the building. Both are required by EN ISO 7396-1 in any hospital with surgical theatres.

What vacuum level is required for hospital pipelines?

EN ISO 7396-3 specifies a minimum vacuum level of 400 mmHg (53 kPa) at every terminal unit.

Hospital vacuum plants typically maintain pipeline vacuum between 500 and 700 mmHg to ensure adequate vacuum at the most distant outlets even at peak simultaneous use.

What pump technology is used for medical vacuum?

Modern medical vacuum plants use oil-free or oil-sealed rotary vane pumps, claw pumps, or screw pumps. Oil-free designs are preferred for low-maintenance operation.

ULTRAVAC plants use proven oil-sealed and oil-free vacuum pump technologies sized to hospital demand profiles, with full filtration of exhaust gases.

What standards apply to hospital medical vacuum?

Medical vacuum plants must comply with EN ISO 7396-1 (medical gas pipeline systems), EN ISO 7396-2 (anaesthetic gas scavenging), MDR (EU) 2017/745 as Class IIb medical devices, and ISO 13485:2016 for manufacturer quality systems.

ULTRAVAC and ULTRASEG hold CE 1639 certification.

Is duplex redundancy required for medical vacuum?

Yes. EN ISO 7396-1 requires N+1 redundancy for medical vacuum plants serving hospital surgical and intensive care areas.

Most installations use duplex configurations with two independent vacuum pumps, allowing one pump to undergo maintenance while the other maintains pipeline vacuum.

How is the exhaust from medical vacuum handled?

Vacuum pump exhaust contains aerosolised body fluids and gases that must be filtered and vented safely. Modern medical vacuum plants include bacterial filtration of exhaust gases and external venting outside the building.

AGSS exhaust is vented separately and should never combine with general vacuum exhaust.

What flow capacities are typical for hospital vacuum?

Hospital vacuum demand depends on bed count and surgical activity:

Small clinics: 30 to 60 m³/hour. Mid-size general hospitals: 100 to 250 m³/hour. Large referral hospitals with multiple ICUs and theatres: 400+ m³/hour.

ULTRAVAC plants span the full range with single, duplex, and triplex configurations.

How long does a medical vacuum plant last?

A well-maintained medical vacuum plant has an operational lifespan of 12 to 18 years. Vacuum pumps require periodic preventive maintenance every 4000 to 8000 hours, depending on duty cycle and pump technology.

Ultra Controlo's UltraCare programme provides full lifecycle support, including spare parts and remote diagnostics.

What dental vacuum is available?

ULTRAVAC DENTAL is a dedicated dental vacuum system designed for dental practices and dental wings of general hospitals. It includes amalgam separation, wet/dry operation modes, and noise levels suitable for clinical environments.

Available in single chair to multi-chair configurations.

Where is ULTRAVAC manufactured and supported?

ULTRAVAC is engineered and manufactured in Lisbon, Portugal by Ultra Controlo since 1981.

The systems are deployed in hospitals, ministries of health, UN agencies, and NGO programmes across more than 80 countries. UltraCare provides 24/7 international technical support, spare parts, and preventive maintenance.

Request a project assessment

Ready to discuss medical vacuum for your hospital?

Ultra Controlo provides free project assessments, system sizing consultations, and technical support throughout the procurement and installation process. Our engineering team in Lisbon is available to discuss your facility, your timeline, and your compliance requirements, including AGSS planning.

CE 1639
MDR Class IIb
EN ISO 7396-1/2
80+ countries
Since 1981