Frequently Asked Questions
Class B Autoclave Premium – key questions answered clearly.
What does "Klasse B" mean for an autoclave?
Klasse B is the highest sterilisation class under EN 13060. Thanks to a fractionated pre-vacuum, even wrapped, hollow and porous instruments are reliably sterilised. A Klasse B device is mandatory for reprocessing critical instruments in medical facilities.
How does the Premium series differ from the Pro series?
Both series sterilise in full Klasse B per EN 13060. Premium adds paperless batch release on the touchscreen, SteriTrace® documentation, LAN/WLAN integration with practice software, label printing and an AI assistant directly on the device. The Pro series documents via USB and printer and is especially price-competitive.
Who benefits most from the Premium series?
The Premium series is aimed at practices and clinics with higher documentation requirements that want paperless RKI documentation, practice software integration and digital batch release – such as dental practices, orthodontics or facilities with several practitioners. Our configurator determines which model suits your workflow in just a few minutes.
What is SteriTrace® and what advantage does it offer?
SteriTrace® is the paperless documentation solution of the Premium series. The sterilisation protocols and batch release are captured directly on the touchscreen and archived digitally – this significantly reduces the documentation effort compared to manual recording with pen and paper.
How does digital batch release on the touchscreen work?
You review the relevant data directly on the screen – visual inspection, load/tray lists, steam indicator, date, protocol per EN 13060, staff number and cycle number – and release the batch with a signature on the touchscreen. This takes just a few seconds instead of several minutes per batch.
Can the Premium autoclave be connected to our practice software?
Yes. The Premium series offers LAN/WLAN connectivity and can be linked to your practice software, so that protocols and releases are transferred digitally into your practice workflow. With the Pro, documentation is handled via the integrated printer and USB.
Is the Premium series CE-certified?
Yes, the devices are CE-certified via TÜV SÜD and operate in full Klasse B per EN 13060. They therefore meet the normative requirements for reprocessing critical instruments.
What size do I need for my practice?
Rule of thumb: 3 L for beauty/podiatry and mobile use, 12–18 L for the typical practice, 23 L for larger practices or several practitioners, 45 L for clinics. The decisive factors are the quantity and length of instruments per cycle. Our configurator recommends the right size in about 2 minutes.
Which size do you recommend for a dental practice?
For dental practices we usually recommend 18 L or 23 L depending on the number of practitioners and the volume of instruments, and ideally a Premium device with documentation and practice software integration when there are several practitioners. For around 15 individually wrapped instruments the 12 L is often sufficient. The configurator gives a specific recommendation.
Which size suits a gynaecological practice?
For gynaecological practices we usually recommend the 23 L, as instruments such as specula are relatively large and need plenty of room; for lower demand an 18 L is sufficient. It is best to use the configurator for a targeted recommendation.
How many instruments or trays fit in the devices?
The 12 L has 3 trays (approx. 18 wrapped instruments), the 18 L and 23 L have 5 trays each. In the 23 L, up to about 20 unwrapped instruments fit per tray. The exact recommendation depends on the quantity and length of your instruments – the configurator can help.
How long may the instruments to be sterilised be at most?
The maximum length depends on the chamber: in the 12 L, instruments should not be longer than about 31 cm; in the 23 L (chamber depth approx. 45 cm), instruments up to about 32 cm fit, and very long instruments up to about 45 cm if placed at an angle. For long instruments we recommend the 23 L.
Can the Premium autoclave sterilise hollow bodies such as handpieces and turbines?
Yes. Klasse B autoclaves are suitable for hollow bodies such as handpieces, turbines and tips, as well as for flexible and critical A/B instruments. The only exceptions are instruments that the manufacturer explicitly marks as not autoclavable.
Which materials may I sterilise in the autoclave?
Suitable materials are stainless steel instruments and heat-resistant plastics that the manufacturer states are autoclavable and can withstand at least 121 °C. With the 18 L and 23 L, the temperature can be set between 105 and 134 °C, so that more sensitive plastics can also be gently sterilised. Single-use products are not intended for reprocessing.
Which sterilisation programmes do the devices offer?
The autoclaves have several programmes, including Universal/Solid, Hollow, Porous/Textile and Prion, as well as a short/quick programme and a vacuum test. The exact list of programmes is given in the operating manual of the respective model.
Which programme do I choose for wrapped instruments?
For wrapped instruments and hollow bodies, use the Hollow programme (e.g. 134 °C Hollow). Solid is for unwrapped instruments without cavities, Porous for textiles. The "134 Solid" programme is not suitable for wrapped instruments.
How long does a sterilisation cycle take?
The duration depends on the model, programme and load. Guide values at full load with wrapped instruments: 12 L approx. 30–35 minutes, 23 L approx. 45–50 minutes, 45 L approx. 90 minutes. The smaller the device, the shorter the running time.
Which sterilisation time and temperature are preset?
By default, 4 minutes at 134 °C are set in accordance with RKI. The sterilisation time can be set between 1 and 60 minutes, but changes are only possible with a password and are not recommended, as the programme would otherwise no longer be EN 13060 compliant.
Do I have to wrap instruments or can I sterilise them unwrapped?
You can autoclave wrapped, unwrapped or in a mixed load. Critical instruments that come into contact with blood or penetrate skin/mucous membranes must be wrapped; non-critical and semi-critical instruments may be sterilised unwrapped.
How long do sealed instruments remain sterile?
In a non-dust-protected environment (a normal drawer) about 6 months, with dust protection (sealing lip) up to 5 years – regardless of whether single or double sealed. The sterile storage period to be stated depends on the packaging and storage.
How do I load the trays correctly?
Ensure sufficient air and steam penetration: do not place instruments too close together, ideally wrap them individually so they do not touch or slide together. Distribute the load evenly and avoid overloading.
Do instruments have to be cleaned before sterilisation?
Yes. Instruments must be cleaned and, depending on their classification, disinfected before sterilisation. Manual pre-cleaning of coarse soiling under running water or with a plastic brush is often sufficient; an ultrasonic cleaner or washer-disinfector simplifies and standardises this step.
Which water do I need for the autoclave?
Use distilled or demineralised/fully desalinated water, with conductivity ideally below 15–20 µS/cm. Commercially available distilled water from a chemist's, supermarket or DIY store is suitable. Tap water and technical battery water are not suitable and can damage the device.
Does the Premium series have a fixed water connection?
All devices have an integrated fresh and waste water tank and can be operated by manual filling. From 12 L upwards, a fixed water connection with drain can be optionally ordered, which is useful for frequent use and can also be retrofitted later.
Do I need a three-phase power connection?
No. A normal household socket is sufficient; three-phase power is not required. Apart from the power connection, no other connection is needed for the model without a fixed water connection.
Does the autoclave have to be in a separate room?
What matters is proper installation with separate areas for unclean and clean in accordance with hygiene requirements. The specific requirements depend on the area of use and the risk class of the instruments; we are happy to advise you on a suitable setup.
Does the autoclave create the sterilisation protocols automatically?
Yes, every autoclave generates and stores the sterilisation protocols with date, programme and other data automatically. With the Premium series they can be archived digitally and transmitted via LAN/WLAN; USB export and printout are also possible.
How do I back up the protocols via USB?
The protocols can be backed up to a USB stick; the USB port is located on the door or at the bottom right of the device. Use a stick that is as empty as possible with a maximum of 16 GB in FAT format. The protocols are saved as txt files.
How is the batch release documented?
Batch release must be documented in accordance with RKI – with the Premium series paperlessly and digitally directly on the touchscreen using SteriTrace®. Alternatively, handwritten documentation is permitted. For critical instruments there is an additional batch tracking and labelling obligation.
How long must sterilisation and release protocols be kept?
The retention periods vary depending on the legal basis: at least 5 years according to RKI, sometimes longer under other legal provisions. We recommend keeping the entire documentation long-term and ideally digitally – the paperless Premium documentation makes this considerably easier.
Does the Premium series help with health authority audits?
Yes. Risk assessment, illustrated tray lists, SOP, manual, digital signature as well as maintenance and validation protocols are available digitally on the touchscreen. Steri24 sets everything up, and the data is updated at every revalidation – this saves research and QM effort.
What can the AI assistant on the Premium autoclave do?
Via the chatbot directly on the device you can schedule appointments for maintenance, validation and repair and ask any kind of question – with an immediate answer on the touchscreen. Steri24 already offers this function today in the Premium series.
Do I have to have the autoclave validated?
For legally compliant operation, when reprocessing critical instruments used on humans, an initial validation is usually required, followed by regular routine checks. Steri24 handles validation and maintenance on site.
Is validation mandatory?
In Germany, validation is mandatory for everyone who reprocesses medical instruments used on humans – the basis includes the MPBetreibV, among others. Those who do not reprocess critical instruments that come into contact with blood are usually not obliged to. If in doubt, we advise you on your area of use.
How does validation work?
During validation, the autoclave and the reprocessing process are assessed on site: using sensors, among other things a vacuum test, an empty chamber profile and several sterilisation runs with your instruments as the load are carried out. You then receive a validation report.
Can I already use the device before validation?
Yes. The initial validation is a process validation and can also be carried out after commissioning; the autoclave is ready to use immediately after delivery and setup. The validation can be commissioned at any later time.
At what interval must the autoclave be serviced?
Maintenance is legally required every 24 months, but earlier as soon as 1,000 sterilisation cycles are reached – regardless of actual usage. This applies in Germany, Austria and Switzerland.
Does Steri24 handle service and maintenance itself?
Yes. Maintenance, validation and repair are carried out by our own trained service technicians or authorised service partners – either on site at your premises or at the factory. This gives you a dense service network as you would otherwise know from established expensive providers, at fairer prices.
Is there on-site service in DE, AT and CH?
Yes. Steri24 operates on site in Germany, Austria and Switzerland with trained technicians and service partners – for installation, validation, maintenance and repair, with a dense network of locations and a 24h emergency line.
Where do I find the nearest service location?
You can find the nearest location in your region on the service map at steri24.de/de/info/servicemap.html. We are also happy to give you the right contact person by phone.
What warranty applies to the Premium series?
A two-year warranty applies as standard, extendable to up to three years with the conclusion of a service contract. Within the warranty period, call-out and repair are free of charge.
How long do the devices last and how long are spare parts available?
With regular maintenance, the autoclaves last many years. We keep spare parts available throughout the entire expected service life, so that long-term operational reliability is ensured.
Can I pay in instalments or lease?
Yes. Instalment payment is possible via Klarna or PayPal; for commercial customers we additionally offer leasing. This allows the purchase to be spread conveniently over the period of use.
How quickly is the device delivered and installed?
The devices are usually available at short notice. On request, we handle delivery, installation and commissioning in accordance with the applicable requirements, as well as the initial validation on site. You can see current availability in the online shop.
Is installation included in the scope of delivery?
On-site installation is not included as standard – you unpack the device and set it up yourself, for which a socket and distilled water are enough. There are instructions and videos; an on-site setup by a technician can be booked optionally.
May I set up and commission the device myself?
Yes. According to the manual, setup and commissioning may be carried out by the user themselves; this is not complicated. On request, our technicians take care of it on site. Validation, on the other hand, must be carried out by an approved validator.
Do I receive instruction on the device?
Yes. Instruction is integrated into commissioning or the initial validation on site. On request we additionally offer training of your staff in instrument reprocessing and sterilisation.
I am replacing an older premium device – does a Steri24 autoclave fit?
Yes. Many practices switch to us when their ageing device fails, and want the same Klasse B performance, better service and a fairer price. Together we find the right replacement model, take back the old device and dispose of it properly.
I don't know Steri24 – why should I buy here?
Steri24 is a brand of CertoClav Sterilizer GmbH from Austria, on the market since 1957. We sell direct – without the detour via depots or middlemen – and handle service ourselves. This gives you a dense on-site service network as with established expensive providers, but at fairer prices.
What does the Premium series cost?
The Premium series offers full Klasse B sterilisation with digital documentation at fair prices; the specific price depends on size and features. You will find current prices and availability in the online shop, or you can use the configurator for a precise recommendation.