Frequently Asked Questions
Dentist – key questions answered clearly.
Which autoclave is suitable for a dental practice?
For dental practices we usually recommend an 18 or 23 L Klasse B autoclave, depending on the number of practitioners and the instrument volume. For several practitioners, a device with digital documentation and practice-software connectivity is ideal. The quickest way to find out which size and equipment fits your workflow is to use the configurator.
Why do I need a Klasse B autoclave in a dental practice?
Klasse B offers full steam sterilization with a fractionated vacuum process and is also suitable for wrapped, hollow and porous instruments. In Germany, a Klasse B device is required for reprocessing critical instruments in dental practices.
What is the difference between Klasse B, Klasse N and Klasse A?
Klasse B uses a vacuum process to sterilize wrapped and unwrapped, hollow and porous instruments. Klasse N may only sterilize unwrapped, solid instruments and is not permitted in human medicine; Klasse A is not a European standard. For a dental practice you need a Klasse B device.
Do your devices meet the RKI requirements?
Yes. All devices are Klasse B in accordance with EN 13060. With SteriTrace® you document every batch in an audit-proof and paperless way; we carry out validation and maintenance on site.
What exactly does Klasse B mean?
Klasse B refers to full steam sterilizers with a fractionated vacuum process that reliably sterilize even wrapped, hollow and porous instruments. In medical facilities in Germany, a Klasse B device is mandatory.
What is the difference between the Pro and Premium models?
The autoclave and operation are essentially the same. The Premium models additionally offer a fixed water connection, WLAN/LAN connectivity to the practice software, as well as paperless batch release and documentation on the touchscreen (SteriTrace®). With the Pro, documentation is handled via an integrated printer or USB.
Which size do I need for my practice?
The right size depends on the number of practitioners and the instrument volume; for many practices 18 to 23 L makes sense. With very high throughput, some practices also install several devices. You receive a specific recommendation including accessories via the configurator.
How many instruments or trays fit into the device?
This depends on the model and the load. Larger devices (18 to 23 L) hold several trays and therefore a larger quantity of instruments per cycle. For a precise assessment, it is best to tell us your typical volume or use the configurator.
Can the autoclave sterilize handpieces, turbines and hollow bodies?
Yes, our Klasse B autoclaves are suitable for hollow bodies such as handpieces, turbines and tips, as well as for flexible and critical A/B instruments. Only instruments that the manufacturer expressly marks as non-autoclavable are excluded.
Which instruments have to be sterilized wrapped?
Critical instruments are sterilized wrapped (sealed); semi-critical instruments may also be autoclaved unwrapped. The decisive factor is the risk classification according to KRINKO. When in doubt, instruments are considered critical and must be wrapped.
How are dental instruments classified according to KRINKO?
Instruments are divided into non-critical, semi-critical and critical; critical instruments are further differentiated (e.g. with cavities or joints). Scalpels are considered critical, hinged instruments such as scissors and needle holders are considered critical B. A classification list from the dental chamber helps with the assignment.
Do PA/perio probes have to be reprocessed wrapped and sterile?
Yes, PA/periodontal probes are critical instruments: cleaning and disinfection in a washer-disinfector or ultrasonic cleaner, then sterilize wrapped in the autoclave and store wrapped.
Do impression posts and gingiva formers have to be sterile and wrapped?
That depends on the risk assessment. Critical instruments must be sterilized wrapped; gingiva formers, which penetrate the gum and come into contact with blood, are to be classified accordingly higher.
Is a washer-disinfector enough or do I also need an autoclave?
A washer-disinfector is responsible for cleaning and disinfection, but it does not replace the sterilization of critical instruments. For instruments that enter sterile areas, sterilization in a Klasse B autoclave is mandatory.
Do I need a sealing device for reprocessing?
Yes, critical instruments are packed in sterilization pouches and sealed before sterilization. With a CertoSeal sealing device you close pouches reliably and with a consecutive batch number. Matching sealing devices and sterilization packaging are available from a single source.
Are the sterilization pouches manufactured to standard?
Yes, our sterilization pouches are manufactured in accordance with DIN EN 868. We offer them as self-sealing pouches and as rolls (by the meter) for sealing devices.
How long does a sterilization cycle take?
The cycle time depends on the program, the load and the model. Full Klasse B cycles with pre-vacuum and drying take longer than pure quick programs. You will find the exact times in the operating manual of the respective model.
Which temperature and holding time apply during sterilization?
In accordance with EN 13060 and KRINKO, sterilization is usually carried out at 134 °C for at least 4 minutes (universal program) or 121 °C for 20 minutes. These standardized values are binding, even if higher temperatures would mathematically allow shorter times.
What is the Helix test needed for?
The Helix test verifies steam penetration for wrapped or hollow instruments. It is standardized in EN 13060; many practices routinely place it in every batch. It is approved for daily routine monitoring of Klasse B autoclaves.
How often does the vacuum test have to be carried out?
You carry out the vacuum test yourself, usually once a week in the morning with a cold chamber. It is standardized in EN 13060 and takes about 15 to 20 minutes. With a warm chamber the program will not start.
Which test strips do I need for daily routine monitoring?
For daily routine monitoring you need steam indicators: the Helix test is for wrapped or critical-B instruments, a Klasse 5 steam indicator for unwrapped or critical-A instruments. The test strip goes into the first cycle of the day.
Do the Helix and vacuum tests replace validation?
No. The Helix and vacuum tests only show partial aspects (steam penetration or tightness). Validation assesses the entire reprocessing process and is mandatory for users in human medicine.
What is the validation of an autoclave?
Validation is a formal test that proves that your autoclave and the entire reprocessing process meet the applicable standards and reliably sterilize. It is carried out on site with your instruments as the load.
Is validation mandatory for a dental practice?
Yes. Anyone who reprocesses critical instruments that come into contact with blood on humans is obliged to validate; the basis is, among others, the MPBetreibV. This applies to dental practices.
How does the initial validation work?
During the initial validation, an accredited validator uses measuring sensors on site to check whether your autoclave meets all requirements at the place of use (including vacuum test, empty-chamber profile and several sterilization runs with your instruments). You then receive a validation report.
Does validation always have to be done on site?
Yes, validation is mandatorily carried out on site with your instruments as the load, because it checks the actual conditions at the place of use. Sending the device to the factory is not possible for this.
At what interval does revalidation have to take place?
Revalidation is usually due every 2 years (or after reaching a certain number of cycles) and is carried out on site. Large devices or very high usage may require a shorter interval.
Can I carry out the validation myself?
No, validation must be carried out by an accredited validator with special measuring equipment and is practically not feasible by yourself. Steri24 handles the complete process on site.
Can I already use the device before the initial validation?
Yes. The autoclave is ready for use after delivery and commissioning; the initial validation can be carried out in a separate appointment. It is a process validation and can also be performed after commissioning.
Do you handle installation and commissioning?
Yes. On request, we handle delivery, installation and commissioning in accordance with the Medical Devices Act, as well as the initial validation on site. According to the manual, you may also carry out the installation yourself.
Will my staff receive an introduction?
Yes, an introduction is integrated into the commissioning or initial validation on site. On request, we also offer training for your staff on sterilization.
How often does maintenance have to take place?
Maintenance is usually required every 24 months, earlier with heavy use (e.g. after reaching a certain number of cycles). It applies regardless of actual usage in Germany, Austria and Switzerland.
Who handles maintenance and repair?
Maintenance and repair are carried out by our own trained service technicians or authorized service partners — either on site at your premises or at the factory.
What does a maintenance contract include?
A maintenance contract secures the required maintenance work and can extend the warranty. We remind you in good time, arrange the appointment and take care of execution, spare parts and report. We are happy to tell you the exact scope and conditions.
What warranty and maintenance options are there?
Our devices are supplied with a warranty that can be extended with a maintenance contract. We offer maintenance and validation on site. You can find out the currently valid warranty and service conditions in the shop or in a no-obligation quote.
How quickly are you on site in a service case?
With 39 locations and over 150 partners in the DACH region, we are quickly on site. In addition, there is a 24h emergency service, even on weekends.
Does the service also come on site in Austria and Switzerland?
Yes, we also have trained technicians and service partners in Austria and Switzerland who come on site for installation, validation, maintenance and repair.
Is there a loaner or replacement device during maintenance or in case of a defect?
For factory maintenance, a limited number of loaner devices is usually available while your device is being serviced. Please contact us about availability in your case.
How does batch documentation work?
You can handle documentation flexibly: via USB/SD, printout or automatic transfer to your practice PC. With SteriTrace® batch release is paperless and RKI-compliant directly on the touchscreen.
What is SteriTrace® and what is it for?
SteriTrace® is the paperless solution for batch documentation and release. It enables digital release, seamless traceability and connection to common practice software — ideal for inspections and QM.
How does the batch number count?
The batch number is a consecutive number that increments by 1 with each program run (per pouch when sealing). With the washer-disinfector, too, the batches must be traceable.
How long do sterilization records have to be kept?
Sterilization, release and reprocessing records must be kept for the periods specified in the applicable regulations and must be traceable at all times. With digital documentation such as SteriTrace® they are available in an audit-proof manner.
Do I need distilled water for the autoclave?
Yes, distilled or demineralized water is required for operation in order to protect the chamber and the instruments. We also offer a suitable water treatment/distilling device.
Does the device need a fixed water connection?
No, a fixed water connection is not necessary. All devices have integrated fresh and waste water tanks and can be operated with manual filling. A fixed water connection is available optionally and can also be retrofitted later.
I don't know Steri24 — why should I switch?
Steri24 sells directly — without going through depots or middlemen — and handles the service itself. This gives you a dense on-site service network like established expensive providers, but at fairer prices. Manufacturer since 1957.
What happens to my old autoclave?
We advise you on the switch, take back your old device and dispose of it properly — regardless of manufacturer. Installation and instruction are included with the switch.
Can you also maintain or validate my existing third-party device?
We usually cannot maintain third-party devices, as we lack the matching spare parts; however, we can validate many third-party devices. Send us the model and manufacturer and we will check your individual case.
Why does Steri24 offer premium performance at fairer prices?
Because we sell exclusively direct and thus save the dealer margins that the end customer otherwise pays for as well. Despite the lower price, you receive full service, on-site support and warranty.
Are the devices approved and tested?
Yes. Our Klasse B autoclaves comply with EN 13060 and are CE-certified (approval via TÜV SÜD). They therefore meet the requirements for instrument reprocessing in human medicine.
What should I do if the Helix test strip does not change color?
A common cause is the wrong program: for the Helix test the hollow-body or Klasse B program must be selected, not the program for unwrapped instruments. If the strip stays brown with the correct program, the autoclave is probably defective — please contact service.
39 locations · 150+ partners
