Frequently Asked Questions
Plastic Surgery – key questions answered clearly.
Which autoclave is suitable for plastic surgery?
For plastic surgery facilities we recommend a Class B autoclave with an 18–45 L chamber volume, since a high instrument throughput occurs here on full surgery days. Both lines – Pro and Premium – are Class B according to EN 13060 and validatable. You will receive the precise recommendation including accessories within a few minutes via our autoclave configurator.
What does Class B mean for an autoclave?
Class B refers to full-fledged steam sterilizers with a fractionated vacuum process that also reliably sterilize wrapped, hollow and porous instruments. For the reprocessing of critical instruments in plastic surgery, a Class B device is mandatory in Germany.
Why is a Class N device not sufficient in surgery?
Class N may only sterilize unwrapped, solid instruments and is not permitted in human medicine. In plastic surgery, wrapped as well as hollow instruments are used, which is why a Class B autoclave with a vacuum process is required.
Which chamber size do I need for full surgery days?
For high instrument throughput we recommend 23 L or 45 L, since more trays and containers can be reprocessed per cycle here. For very high demand, many facilities set up several devices in parallel. Which size suits your volume is something we determine together in the configurator.
How many instruments fit into the autoclave per cycle?
The capacity depends on the size and length of the instruments: larger chambers (18/23 L) generally have five trays, and in the 23 L up to around 20 unwrapped instruments fit per tray. The 45 L accordingly offers more volume for high throughput. For a precise loading recommendation, please use the configurator.
What is the difference between Premium and Pro?
Both lines are Class B and validatable. Premium additionally offers digital batch release on the touchscreen, LAN/WLAN, connection to common practice software and the SteriTrace® assistant for paperless documentation. Pro is robust and great value with documentation via USB and thermal printer.
Which line is right for a fully digital, networked practice?
For networked, paperless reprocessing we recommend the Premium line with digital batch release on the touchscreen, LAN/WLAN and connection to your practice software. This allows every batch to be documented audit-proof and without paper.
Do I meet the RKI requirements with your devices?
Yes. All devices are Class B according to EN 13060. With SteriTrace® you document every batch audit-proof and paperlessly; validation and maintenance we carry out on site on request. This way you meet the requirements reliably.
What does the validation of an autoclave mean?
Validation is a formal inspection that demonstrates that your autoclave and the entire reprocessing process meet the applicable standards and sterilize reliably. It is carried out at regular intervals on site with your instruments as the load.
Is validation mandatory in plastic surgery?
Yes. Anyone who reprocesses critical instruments that come into contact with blood or mucous membranes on humans is obliged to validate; the basis is, among other things, the MPBetreibV. This applies to plastic surgery. We handle the complete process on site.
How does the initial validation on site work?
An approved validator uses measuring sensors to check whether your autoclave meets all requirements at the place of use – including a vacuum test, empty-chamber profile and several sterilization runs with your instruments. You then receive a validation report.
Does validation always have to take place on site?
Yes, validation must be carried out on site with your instruments as the load, since it checks the actual conditions at the place of use. Sending a device to the factory for this is not possible; a device sent in can be maintained, but not validated.
Can I carry out the validation myself?
No, validation must be carried out by an approved validator with special measuring equipment and cannot be done by yourself. According to the manual, you may set up and commission the device yourself; the validation is carried out by us or another approved provider.
At what interval must revalidation be carried out?
Revalidation is generally due every 2 years; for larger devices such as the 45 L or with a high number of cycles, an earlier or annual requalification may be required. We coordinate the exact intervals with your device and your volume.
Does Steri24 offer a complete solution from a single source?
Yes. Autoclave, washer-disinfector, sealing device, water treatment and validation are available completely from a single source – installed, instructed and maintained. This way you bundle the entire reprocessing with one point of contact.
What is the purpose of a washer-disinfector in reprocessing?
A washer-disinfector (WD) handles the automated cleaning and thermal disinfection of the instruments and is preferred according to KRINKO for semicritical and critical medical devices. However, it does not replace the subsequent sterilization of critical instruments in the Class B autoclave.
Why do I need a sealing device?
With a sealing device you package critical instruments in transparent sterile pouches before sterilization. Our CertoSeal sealing devices are validatable; the validation of the sealing process is indirectly required by standards and the MPBetreibV.
What is the purpose of water treatment on the autoclave?
Class B autoclaves require demineralized water. Water treatment ensures automatic refilling with the appropriate water quality and protects the device from limescale and poor water quality. This keeps operation trouble-free.
What documentation options are available?
Depending on the line, you document via USB/SD, printout or automatic transfer to your practice PC. The Premium line additionally offers paperless, digital batch release with SteriTrace® and connection to common practice software – RKI-compliant and audit-proof.
What is SteriTrace®?
SteriTrace® is our assistant for paperless, RKI-compliant batch documentation. Every batch is recorded with seamless traceability and can be released digitally – ideal for inspections, audits and QM.
How does digital batch release work?
With the Premium line you release every batch paperlessly on the touchscreen or via your practice software. This creates seamless, digital traceability that is immediately available during inspections and in QM.
Can the autoclave be connected to our practice software?
Yes, the Premium line has LAN/WLAN and can be connected to common practice software. This way the batch documentation flows directly into your patient or QM management.
Can the autoclave sterilize hollow bodies and flexible instruments?
Yes, our Class B autoclaves are suitable for hollow bodies, flexible instruments and critical A/B instruments. Excluded are only instruments that the manufacturer expressly marks as not autoclavable.
What is the difference between critical and semicritical instruments?
Semicritical medical devices come into contact with mucous membranes or pathologically altered skin, while critical ones penetrate skin, mucous membranes or tissue or come into contact with blood. Critical instruments must be cleaned, disinfected, wrapped and sterilized in the Class B autoclave.
How are containers integrated into the reprocessing process?
For high instrument throughput, suitable containers and trays can be used that are placed into the chamber of the larger devices (18–45 L). Which loading solution suits your surgery volume is something we clarify in the consultation or in the configurator.
How quickly are the devices available and installed?
Devices are generally available at short notice. On request we handle delivery, installation and commissioning in accordance with the Medical Devices Act as well as the initial validation on site. We arrange the exact date individually with you.
Is on-site commissioning mandatory?
On-site commissioning is legally required in Germany, but according to the user manual it may also be carried out by the operator themselves. On request, our technicians handle set-up, commissioning and instruction.
Can the device already be used before the initial validation?
Yes. The autoclave is ready for use immediately after delivery and commissioning. The initial validation is a process validation and can be carried out at a separate appointment; the device can already be used until then.
How quickly do I get an appointment for installation or validation?
You generally receive an appointment within 1–2 weeks, often faster in larger cities. In cases of particular urgency, it can possibly be scheduled earlier with justification.
Is the initial validation included in the device price?
The initial validation is not automatically included in the device price, since it must be carried out on site. You can order it directly with the autoclave or add it separately afterwards.
Do you handle set-up, installation and instruction?
Yes. We carry out set-up, installation and initial validation on site on request, with instruction integrated. On request we also train your staff in sterilization.
What happens to my old autoclave?
We advise you on the switch, take back your old device and dispose of it properly – also independently of the manufacturer. Dismantling and disposal take place on request in the course of installing the new device.
I don't know Steri24 – why should I switch?
Steri24 sells directly – without the detour via depots or intermediaries – and handles the service itself. This gives you a dense on-site service network like that of established expensive providers, but at fairer prices. Manufacturer since 1957.
Why replace an older premium device with Steri24?
Most practices come to us because they are replacing an older premium device that has gotten on in years – and want to keep the performance while improving service and price. You receive the same premium performance, faster on-site service throughout DACH and a fairer price.
Do I get the same performance as with expensive providers when switching?
Yes. Our Class B devices according to EN 13060 offer full-fledged sterilization, digital documentation and practice software connection – the same premium performance as established expensive providers, but at a fairer price and with faster on-site service.
How is service organized in the DACH region?
We are present with 39 locations and over 150 partners in the DACH region and come on site for installation, validation, maintenance and repair – with free travel in Germany, Austria and Switzerland. In addition, there is a 24h emergency service.
Is there a service partner in my region?
Yes, we have trained service partners on site in Germany, Austria and Switzerland. You can find the nearest location in your region on our service map.
How quickly is a technician on site in the event of a fault?
Our autoclaves run very reliably. In the event of a fault, a technician can usually be reached within a few days, and a 24h emergency service is available – also on weekends. If needed, we can bridge your work with a replacement device.
Is there a replacement device during maintenance or in case of a defect?
Yes, we provide a limited number of loan devices, especially in the event of a repair, so that your surgery operations are not interrupted. The loan device is delivered with the necessary accessories.
What maintenance and warranty options are available?
As standard, you receive a warranty on your device, which can be extended with a maintenance contract.* We offer maintenance and validation at a fixed price including travel. We will gladly state the exact terms in the quote.
What does a maintenance contract include?
A maintenance contract secures the legally required maintenance and extends the warranty. We remind you in good time, arrange the appointment and take care of the execution, spare parts and report; the contract itself is free of charge.
How often must the autoclave be maintained?
Maintenance is legally required every 24 months, but earlier as soon as 1,000 sterilization cycles are reached. Larger devices such as the 45 L require annual maintenance due to the higher load.
How long do the devices last?
With regular maintenance, our autoclaves last around 20–25 years. We keep spare parts in stock accordingly. During maintenance, all critical wear parts are replaced as scheduled.
Do you also offer service after the warranty has expired?
Yes, we repair and maintain your device even after the warranty has expired – also without a maintenance contract. The usual service and spare part costs then apply.
How much does a complete package for plastic surgery cost?
The costs depend on the device selection, capacity and accessories. We put together a complete package of autoclave, washer-disinfector, sealing device, water treatment and validation individually. Via the configurator or a short consultation you receive a no-obligation quote.
What is the benefit of a set compared to buying individually?
Our sets bundle the autoclave and matching accessories at a discount and generally contain everything important for instrument reprocessing. This way you receive a coordinated complete package from a single source instead of individually procured components.
How is reprocessing divided into a clean and an unclean area?
The KRINKO recommendations provide for a clear separation of the unclean and clean area. As a rule, you need an unclean and a clean area for critical instruments as well as, depending on the risk class, a washer-disinfector. We advise you on the appropriate process chain.
Which standard do your autoclaves meet?
Our autoclaves are Class B according to EN 13060 and CE-certified via TÜV SÜD. This means they meet the requirements for the steam sterilization of critical instruments in human medicine.
How do your devices support inspections and QM?
With initial validation, requalification and SteriTrace® you document every batch traceably and audit-proof. The paperless, seamless traceability and the connection to common practice software make inspections and QM easier.
What should I do about residual moisture or standing water in the chamber?
Residual moisture or standing water can have several causes, such as loading, drying or the seal. Please fill out the service form at steri24.de/help, and a technician will then contact you to solve the problem.
39 locations · 150+ partners
