Is a hydraulic pressure test required every 10 years?
Is a hydraulic pressure test required?
When the hydraulic pressure test is mandatory — and why it does not apply to most practice devices.
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Short answer
A hydraulic pressure test every 10 years is only required under the Pressure Equipment Directive for autoclaves over 23 litres. Steri24 autoclaves up to 23 litres do not need one.
Pressure test: when is it mandatory?
According to the Pressure Equipment Directive, a hydraulic pressure test is required every 10 years for autoclaves over 23 litres. Below that, the pressure test does not have to be carried out, unless the manufacturer specifies other guidelines.
For Steri24 autoclaves up to 23 litres, it is not necessary to have a hydraulic pressure test carried out.
For Steri24 autoclaves up to 23 litres, it is not necessary to have a hydraulic pressure test carried out.
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Frequently Asked Questions
Hydraulic Pressure Test – key questions answered clearly.
What is a hydraulic pressure test for an autoclave?
In a hydraulic pressure test, the pressure vessel of the autoclave is tested with liquid (water) at elevated pressure to verify the strength and tightness of the chamber. It serves to ensure safety during operation under steam pressure.
Does my autoclave need a hydraulic pressure test?
A hydraulic pressure test every 10 years is only required under the Pressure Equipment Directive for autoclaves over 23 litres. Steri24 autoclaves up to 23 litres do not need one, provided the manufacturer does not specify otherwise.
From what size is the hydraulic pressure test mandatory?
Under the Pressure Equipment Directive, the hydraulic pressure test is required every 10 years for autoclaves over 23 litres. Devices up to and including 23 litres are exempt.
At what interval must the hydraulic pressure test be carried out?
For autoclaves over 23 litres, the hydraulic pressure test is scheduled every 10 years under the Pressure Equipment Directive. For smaller devices it does not apply.
Does a Class B autoclave up to 23 litres need a pressure test?
No. Steri24 autoclaves up to 23 litres do not need a hydraulic pressure test, unless the manufacturer specifies other guidelines.
Why does the pressure test not apply to most practice devices?
Most practice autoclaves have a chamber up to 23 litres and therefore fall under the exemption of the Pressure Equipment Directive. Only above 23 litres does the recurring hydraulic pressure test every 10 years become required.
Which regulation governs the hydraulic pressure test?
The obligation for a recurring hydraulic pressure test arises from the Pressure Equipment Directive. Accordingly, it is only necessary every 10 years for autoclaves over 23 litres.
My autoclave has 45 litres - do I need a pressure test?
Yes, for autoclaves over 23 litres a hydraulic pressure test is scheduled every 10 years under the Pressure Equipment Directive. We will be happy to advise you on the specific procedure for your device.
What is checked during the hydraulic pressure test?
The strength and tightness of the pressure vessel are tested under elevated water pressure. This ensures that the chamber permanently withstands the operating pressure safely.
Is the hydraulic pressure test the same as validation?
No. The hydraulic pressure test checks the pressure resistance of the vessel, while validation verifies the reliable sterilisation performance of the entire process. These are two separate inspections with different purposes.
Is the hydraulic pressure test the same as maintenance?
No. Maintenance covers the scheduled replacement of critical parts and the functional check, whereas the hydraulic pressure test specifically checks the pressure resistance of the vessel and is only required every 10 years for devices over 23 litres.
Does the autoclave additionally need the annual electrical test (DGUV V3)?
The electrical test according to DGUV V3 is an inspection to be organised by the operator and is independent of device maintenance and validation. Please arrange this with a qualified electrician authorised for the task.
Do you offer inspections according to BetrSichV (internal, external, strength)?
Inspections according to BetrSichV (pressure vessel inspection) are not part of the standard maintenance scope. Please let us know your device, and we will check whether and how we can support you with it.
Do you offer devices for insulation testing of HF-capable surgical instruments?
No, we do not carry such insulation testers for HF instruments in our range. We offer sterilisation tests such as Helix tests and Class 5 steam indicators, which are however not suitable for insulation testing.
Who is allowed to carry out the hydraulic pressure test?
The recurring pressure test under the Pressure Equipment Directive is a technical inspection and is not part of the standard maintenance scope. Let us know your device, and we will check how we can support you with it.
What happens if I miss the pressure test on a device over 23 litres?
For devices over 23 litres, the hydraulic pressure test every 10 years is an operator obligation. Omissions can affect operational safety and insurance cover. Please clarify the interval in good time with a competent inspection body.
Does the hydraulic pressure test also apply in Austria and Switzerland?
The obligation for a recurring pressure test depends on the respective applicable national pressure equipment or operational safety requirements. As these can differ in DE, AT and CH, we will be happy to advise you regarding your location and device.
My manufacturer prescribes a pressure test even below 23 litres - what applies?
If manufacturer guidelines prescribe a pressure test even below 23 litres, these must be followed. In general, however, the pressure test is not required below 23 litres. For Steri24 devices up to 23 litres it is not necessary.
Which mandatory inspections are there for my autoclave besides the pressure test?
In addition to the hydraulic pressure test (only over 23 litres), maintenance, validation or revalidation and the electrical test according to DGUV V3 are relevant depending on use. We will be happy to clarify which inspections apply to your device and your use.
Will I forget a mandatory inspection?
With our maintenance package, we keep track of all due inspections for your device, so you do not have to remember anything. We remind you in good time and arrange the appointment.
How often must my autoclave be serviced?
Maintenance is generally required every 24 months, but earlier as soon as 1,000 sterilisation cycles are reached. This applies regardless of actual usage.
What is the difference between pressure test, maintenance and validation?
The pressure test checks the pressure resistance of the vessel (only over 23 litres, every 10 years), maintenance ensures technical function through parts replacement (every 24 months or 1,000 cycles), and validation verifies the sterilisation performance (generally every 2 years). These are three separate inspections.
Is the pressure test dangerous for my device?
No. The hydraulic pressure test is carried out with water and controlled test pressure and is an established, gentle safety procedure. It is specifically intended to verify long-term operational safety.
Why is there a pressure test for autoclaves at all?
An autoclave works with steam under pressure. For larger pressure vessels, the hydraulic pressure test ensures that the chamber permanently withstands the operating pressure safely, thereby protecting users and patients.
Do you carry out the pressure vessel inspection for my existing device?
Inspections according to BetrSichV or the Pressure Equipment Directive are not part of the standard maintenance scope. Let us know the model and manufacturer of your device, and we will assess the individual case and support you where possible.
How does the safety mechanism differ in Steri24 autoclaves?
Our Class B autoclaves are built as medical devices, designed according to EN 13060 and CE-certified via TÜV SÜD. The pressure vessel, safety valve and controls are designed for safe continuous operation.
Water or steam is escaping from the safety valve - what should I do?
A slight leak at the safety valve can have various causes. Please describe the fault via the service form at steri24.de/help (a photo is welcome), and a technician will contact you with a solution.
Do I have to organise the pressure test myself?
For devices over 23 litres, the recurring pressure test is an operator obligation. As it is not part of the standard maintenance scope, we will be happy to support you with the arrangements after consultation - just let us know your device.
Can I combine maintenance, validation and pressure test?
Maintenance and revalidation can sensibly be bundled into one appointment. The pressure test has its own interval (every 10 years, only over 23 litres); whether a combination makes sense in an individual case is something we will be happy to clarify with you.
Which autoclave suits my practice without a pressure test obligation?
Devices up to 23 litres are exempt from the hydraulic pressure test obligation and cover most practice requirements. You can quickly find out which chamber size suits your instrument volume in the autoclave configurator.
Is a larger device worthwhile despite the pressure test obligation?
Devices over 23 litres offer more capacity but are subject to the recurring pressure test every 10 years. We will be happy to assess together whether a larger model makes sense for your volume, via the configurator or a consultation.
What is the operating pressure of a Class B autoclave?
Class B autoclaves work with saturated steam under positive pressure, usually at sterilisation temperatures of 121 °C or 134 °C. The pressure vessel is safely designed and tested for this operating pressure.
Does the pressure test affect the warranty?
The recurring pressure test for devices over 23 litres is a statutory operator obligation and concerns operational safety. For questions about warranty and maintenance contracts, we will be happy to advise you individually.
What is the difference between pressure test and vacuum test?
The vacuum test checks the tightness of the chamber under vacuum during operation and is carried out regularly. The hydraulic pressure test, by contrast, checks the pressure resistance of the vessel under positive pressure and is only scheduled every 10 years for devices over 23 litres.
How often do I carry out the vacuum test?
The vacuum test is part of the regular operational check and is usually carried out each working day before the first batch. It is not to be confused with the hydraulic pressure test.
Failure during the vacuum test - is this related to the pressure test?
No. A fault during the vacuum test (e.g. Fail 01/02) usually indicates air in the chamber, often due to the door seal. A short guide can be found on the inside of the door; if that does not help, please use the form at steri24.de/help.
Who comes on site for the inspections?
For maintenance and validation, our trained technicians and service partners come to you with free travel in DE, AT and CH. For the hydraulic pressure test over 23 litres, we clarify the appropriate solution after consultation with you.
Is there a service location in my region?
Yes, we are present on site with 39 locations and over 150 partners in DE, AT and CH. You can find the nearest location on the service map at steri24.de/de/info/servicemap.html.
Does Steri24 remind me of due inspections?
Yes. As part of the maintenance package, we keep track of all due inspections for your device and remind you in good time, so you do not miss a deadline.
Do I get a loaner device if my device has to go in for inspection?
Yes, in an emergency or during longer service operations we provide a loaner device subject to availability, so you do not face downtime. We will be happy to clarify the details with you.
Do I have to send in my device for the pressure test?
That depends on the device and the required inspection. As the pressure test is not part of the standard maintenance scope, please let us know your model, and we will assess the procedure and advise you on the appropriate process.
Is the pressure test mandatory for veterinary practices?
The hydraulic pressure test obligation depends on the device size (over 23 litres), not on the sector. For validation, different rules apply in the purely veterinary field. We will be happy to advise you on your specific case.
How much does the hydraulic pressure test cost?
As the pressure test is not part of the standard maintenance scope and depends on the device, we will quote the cost after consultation. Please tell us the model and location, and we will prepare a suitable offer for you.
How do I book maintenance or an inspection for my autoclave?
You can book maintenance directly online or send your contact details to support@certoclav.com. We will prepare a non-binding offer and arrange the appointment - either on site or at the factory.
Are Steri24 autoclaves approved as medical devices?
Yes, our Class B autoclaves are medical devices according to EN 13060 and CE-certified via TÜV SÜD. They thus meet the applicable safety and performance requirements.
How long do Steri24 autoclaves last?
With regular maintenance, our autoclaves last around 20-25 years. The prerequisite is the due maintenance every 2 years or after 1,000 cycles, including scheduled replacement of critical parts.
What does Class B mean for safety in an autoclave?
Class B according to EN 13060 stands for the most demanding process with fractionated vacuum, which also reliably sterilises hollow and wrapped instruments. It is the suitable standard for reprocessing critical instruments used on humans.
How does Steri24 differ from established expensive manufacturers?
We offer equivalent Class B performance according to EN 13060 at fairer prices, combined with a large on-site service network in DE, AT and CH as well as a 24h emergency line. Other providers are often more expensive and slower in service.
Who do I contact with questions about the pressure test of my device?
Let us know the model and location of your device, and we will assess whether and how a hydraulic pressure test is required, and advise you on the further procedure. You can reach us via the service channels or the 24h emergency line.
Which size should I choose to keep obligations to a minimum?
If you stay with a chamber up to 23 litres, the hydraulic pressure test does not apply. You can quickly and without obligation determine which size covers your instrument volume in the autoclave configurator.