Frequently Asked Questions
Hair Clinic – key questions answered clearly.
Which autoclave is suitable for a hair clinic?
For hair clinics we recommend a Class B autoclave with a 18–45 L chamber volume, since on surgery days many instruments and sets have to be reprocessed in a short time. Both the Pro and the Premium line are validatable; which model and which size fits best can be determined in just a few minutes via our configurator.
Why do I need a Class B autoclave in hair surgery?
Surgical instruments in hair surgery penetrate skin and tissue and are therefore considered critical medical devices that must be sterilized. Class B reliably sterilizes packaged, hollow and porous instruments as well using the fractionated vacuum process – for reprocessing in medical facilities, a Class B device is required in Germany.
What does Class B mean for an autoclave?
Class B refers to full-fledged steam sterilizers with a fractionated vacuum process that can also sterilize packaged, hollow and porous instruments. For instrument reprocessing in medical facilities such as hair clinics, a Class B device is required in Germany.
What is the difference between Class A, B and N?
Class B offers full sterilization with a vacuum process for packaged, unpackaged, hollow and porous instruments. Class N may only sterilize unpackaged, solid instruments and is not permitted in human medicine; Class A is not a European standard. For a hair clinic you need a Class B device.
What size should the autoclave for a hair clinic be?
For the high instrument throughput on surgery days we recommend 18–45 L. Larger chambers hold more sets and containers per batch, which reduces waiting times between procedures. We are happy to clarify which size fits your daily volume individually or via the configurator.
Can surgical sets and containers be reprocessed in the autoclave?
Yes. Our 18–45 L Class B autoclaves are designed for the throughput of complete surgical sets and hold matching sterilization containers. We are happy to check whether your existing containers and tray dimensions fit into the respective chamber.
Can hollow bodies and fine surgical instruments be sterilized?
Yes, our Class B autoclaves are suitable for hollow bodies, fine surgical and critical instruments. The only exceptions are instruments that the manufacturer expressly marks as not autoclavable.
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 paperless; on request, we carry out validation and maintenance on site.
What is the validation of an autoclave?
Validation is a formal test that proves your autoclave and the entire reprocessing process meet the applicable standards and sterilize reliably. It is usually carried out on site with your instruments as the load.
Is validation mandatory for a hair clinic?
In Germany, validation is mandatory for everyone who reprocesses medical instruments used on people, which also includes hair clinics performing surgical procedures. The legal basis includes the MPBetreibV. We handle initial validation and requalification on site.
How does the on-site initial validation work?
During the initial validation, a technician tests the device at the installation site with your typical loads and documents that the process sterilizes in accordance with the standards. It usually comprises IQ/OQ and provides audit-proof evidence for QM and inspections.
How often must revalidation be carried out?
Revalidation is usually carried out on site every two years, depending on the applicable requirements and your service contract. We remind you of due dates and come to you directly for maintenance and requalification.
Do you handle installation, commissioning and validation on site?
Yes. On request, we handle delivery, installation, commissioning in accordance with the Medical Devices Act, and the initial validation on site – from a single source and throughout DACH.
Who performs the validation – can I do it myself?
Validation is performed by qualified technicians and cannot be carried out by the practice staff themselves, as measurement technology and documented evidence are required. We offer initial validation and requalification as an on-site service.
Must validation always be carried out on site?
Yes, validation is carried out at the installation site, because the entire process including the real load and ambient conditions is tested. Our technicians come to your hair clinic for this.
How soon after purchase must the initial validation be carried out?
The initial validation should be carried out promptly after installation and commissioning, before the device is used routinely for patient care. We coordinate the appointment directly with you and ideally carry out commissioning and validation together.
Do you offer autoclave, washer-disinfector and validation from a single source?
Yes. We supply the complete reprocessing chain – Class B autoclave, washer-disinfector, sealing device and water treatment – install it, validate it on site and service everything centrally. This way you have one point of contact for the entire reprocessing.
Why do I additionally need a washer-disinfector?
The washer-disinfector (RDG) handles the mechanical, reproducible cleaning and disinfection of the instruments before sterilization. It does not replace the autoclave but is a separate, documentable step in the validatable reprocessing chain – particularly useful for surgical instruments.
Is a washer-disinfector enough, or do I also need an autoclave?
A washer-disinfector cleans and disinfects but does not replace the sterilization of critical instruments. For instruments that enter sterile body areas – as in hair-surgical procedures – sterilization in the Class B autoclave is mandatory.
What is the difference between the Pro and Premium autoclaves?
The Pro line is robust, easy to operate and great value, with documentation via USB and thermal printer. The Premium line additionally offers digital batch release on the touchscreen, LAN/WLAN, integration with practice software and the SteriTrace® Assistant for paperless documentation.
What is SteriTrace® and how does it help with documentation?
SteriTrace® is our solution for paperless, RKI-compliant batch documentation. Every batch is recorded seamlessly and traceably, and release is carried out digitally on the touchscreen – ideal for inspections and QM in the hair clinic.
Can the autoclave be connected to our practice software?
Yes, the Premium models can be connected via LAN/WLAN to common practice software, so that records are transferred automatically and assigned to the patient file. This way the batch documentation becomes part of your digital workflow.
How does batch release work?
Depending on the model, you release batches paperlessly on the touchscreen or in the classic way using a template. With the Premium devices, digital release is carried out with seamless traceability and optional integration with your practice software.
How are the sterilization records stored?
Depending on the model, the records can be saved via USB/SD, printed out or transferred automatically to your practice PC. This way you meet the requirements for traceable, RKI-compliant documentation.
Does the autoclave create the documentation automatically?
Yes, our Class B autoclaves log every cycle automatically. With the Premium models, this creates paperless, audit-proof batch documentation that you can release and archive digitally.
Does the autoclave indicate whether sterilization was successful?
Yes. The autoclave monitors every cycle and reports at the end whether the process was passed. The result is recorded in the log and forms the basis for batch release.
How long does a sterilization cycle take?
The cycle duration depends on the program, load and model. There are faster programs for unpackaged instruments as well as longer programs for packaged, hollow and porous instruments including drying. For high surgery volumes, short cycles and large chambers are decisive.
What water must be used for the autoclave?
Class B autoclaves require demineralized or distilled water of the appropriate quality to avoid limescale deposits and corrosion. With our AQUAdem water treatment you conveniently produce or fill the appropriate feed water.
Does the autoclave need a fixed water connection?
The devices can be filled manually with an internal tank or supplied automatically via a fixed water connection. Especially with high throughput in a hair clinic, the automatic connection with water treatment is convenient; we advise you on the right configuration.
Is a normal power outlet enough or is three-phase power required?
That depends on the model and size. Smaller devices usually run on a normal earthed socket, larger ones may require a stronger connection. We check the electrical requirements in advance and clarify them during installation.
What spatial requirements do I need for the autoclave?
Important factors are a load-bearing setup surface, sufficient clearance from the wall for heat dissipation and a suitable power and, if necessary, water/wastewater connection. During installation we advise you on the location and connections in your clinic.
Must instruments be cleaned before sterilization?
Yes, cleaning and disinfection is a separate, upstream step – ideally mechanically in the washer-disinfector. Only properly reprocessed instruments can be sterilized safely; remaining residues compromise sterilization.
Must surgical instruments be sterilized packaged?
Instruments that are stored sterile and later used on the patient are sterilized packaged so that sterility is maintained until use. For this you need a Class B device and a suitable sealing device such as CertoSeal.
Do you offer a validatable sealing device?
Yes, with the CertoSeal sealing devices you package critical instruments reliably and documentably. The devices are validatable and integrate seamlessly into the rest of the reprocessing chain.
How long do sealed instruments remain sterile?
The storage period depends on the packaging, storage conditions and your internal specifications. Correctly sealed sterile goods stored dry and dust-protected remain sterile for a defined period; you set the exact deadline in your QM.
What is the maximum length the instruments may be?
The maximum instrument length depends on the chamber depth of the respective model. For longer surgical instruments we recommend larger chambers; we are happy to check which size fits based on your instruments.
I don't know Steri24 – why should I switch?
Steri24 sells directly – without the detour via depots or middlemen – and handles the service itself. This way you get a dense on-site service network like that of established expensive providers, but at fairer prices. Manufacturer since 1957.
How is your service organized in the DACH region?
We operate a dense service network with 39 locations and over 150 partners across DACH and are there for you directly from the manufacturer – without middlemen. This way we are quickly on site when needed.
Is there an emergency service if the device fails?
Yes, we offer a 24h emergency service, even on weekends. Especially in a hair clinic with scheduled surgery days, fast help is decisive so that operations do not come to a standstill.
Is there a loan or replacement device during maintenance or in case of a defect?
Depending on the situation and contract, we provide a replacement device for the duration of maintenance or repair so that your reprocessing continues. Talk to us about it and we will find a solution for your surgical operations.
What happens to my old autoclave?
We advise you on the switch, take back your old device and dispose of it properly – regardless of the manufacturer. This makes the changeover straightforward for you.
Can you also replace our current premium device?
Yes. Most clinics come to us because they want to replace an older premium device without compromising on performance, but improving service and price. We offer the same premium performance, faster on-site service in DACH, plus take-back and disposal of the old device.
Do you offer maintenance and warranty options?
By default there is a manufacturer's warranty that can be extended by taking out a service contract. We offer maintenance and validation at a fixed price including travel; we are happy to state the specific conditions in the quote.
What does a service contract include?
A service contract bundles regular maintenance, requalification and service at plannable fixed prices including travel and can extend the warranty. This way your device remains permanently compliant and ready for use – without unpredictable individual costs.
At what interval must the autoclave be serviced?
Maintenance is usually carried out at a defined interval – often every two years, depending on usage and manufacturer specifications – frequently together with the requalification. We remind you of due dates and carry out the maintenance on site.
Do you offer training of the staff on the device?
Yes, on request we train your team during installation and commissioning in operation, loading and documentation. This way your staff is confident in handling the device from the start.
How quickly are delivery and installation possible?
Devices are usually 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 coordinate specific dates individually with you.
Are your devices cheaper than the established expensive providers?
Yes. Because we sell directly from the manufacturer without middlemen and provide the service ourselves, we offer premium performance at fairer prices than established higher-priced providers. The comparative statements refer generally to the market, without naming specific brands.
Am I prepared for a QM inspection with your devices?
Yes. With initial validation, requalification and the paperless documentation via SteriTrace®, you meet the requirements reliably and audit-proof. Every batch is traceable – ideal for inspections and your QM.
How do I find out which device and which size fits my hair clinic?
The easiest way is via our autoclave configurator: in about two minutes you receive a suitable recommendation including accessories for your surgical operations. Alternatively, we advise you personally and prepare a no-obligation quote.