Validation
Validation of all devices
Steri24 validates your entire instrument reprocessing — autoclave, sealing device and thermal disinfector — standards-compliant, manufacturer-independent and directly at your practice. You receive seamless documentation that withstands any hygiene audit.
Germany
Austria
Switzerland
Standards-compliant documentation
Manufacturer-independent
Fast on-site service
The right validation for every device
Choose your device type — we validate on site and deliver audit-proof evidence.
We validate devices from all manufacturers.
No matter which manufacturer your devices come from — our certified technicians validate them to standard. One point of contact for your entire reprocessing, without the detour via the device manufacturer.
How your validation works
Three qualification stages — fully documented and audit-proof.
1
Installation Qualification (IQ)
Inspection of setup and connections — is the device correctly installed and ready for use?
2
Operational Qualification (OQ)
Verification of the process parameters with calibrated measuring equipment — temperatures, times, pressures.
3
Performance Qualification (PQ)
Proof of the safe result with real-world loads — incl. validation report and inspection sticker.
No shipping. No downtime.
Our technicians come to you directly with calibrated measuring equipment. Your reprocessing stays ready for use — and you receive documentation that withstands every inspection.
- Schedulable during ongoing practice operations
- Complete, audit-proof validation report
- Reminder service for the next revalidation
- Personal contact in your region
There where you need us.
A dense service network with our own service vehicles and trained technicians.
39
Service locations
Each with its own service vehicle.
150+
Certified partners
Dense service area across the DACH region.
4.9★
Google rating
From verified reviews.
1957
Since
60+ years of experience.
What our customers say
4.9 out of 5 stars on Google — from verified reviews.
MK
Maud Kolb · Google review
„Fast delivery, good advice, great price. Maintenance and validation nearby. I'm happy. Thank you!“
SG
Stephanie Grebe · Google review
„I am very positively impressed by the very good, honest, patient advice. You felt well taken care of.“
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Frequently Asked Questions
Validation – key questions answered clearly.
What does validation of a reprocessing device mean?
Validation is a formal, documented inspection that demonstrates your device and the entire reprocessing process meet the applicable standards and reliably deliver reproducible results. It considers not only the device but the complete process under your real on-site conditions.
Is validation mandatory?
Anyone who reprocesses medical instruments used on humans is required to validate in Germany; the legal basis includes the MPBetreibV. As soon as critical instruments that come into contact with blood are reprocessed, validation is required. We are happy to assess individually whether it applies in your case.
Does Steri24 also validate devices from other manufacturers?
Yes. We validate devices from all manufacturers, independent of the manufacturer. Our certified technicians inspect your reprocessing to standard on site, regardless of who made the device, so you have a single point of contact for your entire reprocessing.
Which devices can Steri24 validate?
We validate your entire instrument reprocessing: autoclave, thermal disinfector and validatable sealing device. Use the device-type selector to simply choose the right validation; alternatively, we advise you personally.
What is Installation Qualification (IQ)?
The IQ checks setup and connections: whether the device is correctly installed, connected to the utility supply and ready for use. This includes, among other things, the match between order and delivery scope, the inspection of safety devices, as well as handover and instruction.
What is Operational Qualification (OQ)?
The OQ verifies the process parameters with calibrated measuring equipment, namely temperatures, times and pressures. Among other things, the correctness and reproducibility of the process sequence, the door and locking mechanism, as well as the fault indication are checked.
What is Performance Qualification (PQ)?
The PQ demonstrates the safe result with real-world loads. It is verified that the process also works reliably with your typical instruments and loading patterns. You receive the validation report and the inspection sticker for this.
How does validation work at Steri24?
Validation is carried out in three documented qualification stages: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Our technicians come directly to you with calibrated measuring equipment and carry out the inspection completely and in an audit-proof manner.
Must validation be carried out on site?
Yes, validation must be carried out at the place of use with your instruments as the load, because it tests the actual on-site conditions. Sending the device to the factory is not possible for this; our technicians come directly to you.
Does my device stay ready for use during validation?
Yes. There is no shipping and no downtime: our technicians validate directly at your location, so your reprocessing stays ready for use and you receive documentation that withstands every inspection.
What do I receive after validation?
You receive a complete, audit-proof validation report including an inspection sticker. This audit-proof documentation proves standards-compliant reprocessing and withstands any hygiene audit.
Does the documentation withstand a hygiene audit?
Yes. Our validation report is structured to be seamless and audit-proof, so it withstands every inspection and every hygiene audit. On request, we explain to you how to present the documents.
Which standards is validation carried out to?
Validation is carried out to the respectively relevant standards: for the autoclave to DIN EN ISO 17665, for the thermal disinfector to EN ISO 15883, and for the sealing device to ISO 11607-2. The inspection follows the recognized rules of technology and the RKI recommendations.
How often must revalidation be carried out?
Validation is a regularly recurring service; the interval depends on the device, usage and number of cycles. Larger devices or high utilization may require earlier revalidation. We agree the exact interval individually with you.
What is the difference between validation and maintenance?
Maintenance is the technical upkeep of the device, such as the replacement of wear parts. Validation is the formal inspection that the entire reprocessing process meets the standards. Both are separate, regularly recurring services.
Can I have maintenance and validation carried out at one appointment?
Yes, this makes sense and is usually more economical. We carry out maintenance and revalidation at one joint on-site appointment and combine both services so that your reprocessing is fully covered with only one visit.
What is an initial validation?
Initial validation is the first complete validation at the place of use after delivery and installation. An approved validator uses measuring sensors to check whether your device meets all requirements at the actual installation site and documents the result in the validation report.
When must initial validation be carried out after delivery?
Initial validation should be carried out promptly after commissioning in a separate on-site appointment. You can already use the device after delivery; we arrange the validation appointment individually with you.
Can I carry out the validation myself?
No. Validation must be carried out by an approved validator using elaborate, calibrated measuring equipment and cannot be performed by yourself. Steri24 handles the complete process on site.
Can I carry out the validation later?
Yes. Validation can be commissioned at a later point in time at any time. The device is already ready for use after delivery and commissioning; the validation can be carried out subsequently in a separate appointment.
Must a new device also be validated even though it has been factory-tested?
Yes. Even a factory-tested new device must be validated at the place of use, because validation tests the actual on-site conditions, namely setup, connections and load. These conditions cannot be reproduced at the factory.
Must a used or refurbished device be revalidated?
Yes, a used or reconditioned device should also be initially validated at the new place of use and then revalidated regularly, since validation assesses the conditions at the respective installation site.
Is validation mandatory in podiatry or foot care?
As soon as you reprocess instruments that come into contact with blood, validation is also mandatory in podiatry and foot care. In pure foot care without critical instruments it is often not required, but can be carried out at any time afterwards.
Must validation be carried out in the veterinary field?
In the purely veterinary field, validation is not legally prescribed, since the obligation applies to the reprocessing of instruments used on humans. Voluntary validation is, of course, possible and advisable.
Must validation be carried out if no critical instruments are reprocessed?
If no critical instruments that come into contact with blood are reprocessed, there is generally no validation obligation. However, as soon as critical instruments used on humans are reprocessed, validation is required. When in doubt, we are happy to advise you.
Can sealing devices be validated?
Yes, validatable sealing devices such as the CertoSeal must be initially validated. In Germany, the validation of the sealing process is indirectly mandatory via standards and the MPBetreibV. We validate your sealing device to standard on site.
Does Steri24 also validate thermal disinfectors?
Yes. We validate thermal disinfectors, or washer-disinfectors (WD), to the relevant requirements on site, independent of the manufacturer and with audit-proof documentation.
What is a process validation?
Process validation assesses not only the device but the entire reprocessing process under real conditions. Our validation is such a process validation and is offered for autoclaves, validatable sealing devices and thermal disinfectors.
Does someone come to my practice for the validation?
Yes. Our trained technicians and certified partners come to you on site with calibrated measuring equipment, throughout Germany, Austria and Switzerland. You have a personal contact in your region.
Does the validation service also apply in Austria and Switzerland?
Yes. We operate on site throughout the DACH region with trained technicians and service partners and validate in Germany, Austria and Switzerland. We take country-specific requirements, for example in Austria or Switzerland, into account in doing so.
How dense is Steri24's service network?
Our service network comprises 39 service locations, each with its own service vehicle, as well as over 150 certified partners in the DACH region. This way we are there where you need us and can carry out the validation promptly on site.
Will I be reminded of the next revalidation?
Yes. We offer a reminder service for the next revalidation, so that you do not miss the appointment and your reprocessing remains standards-compliant and audit-proof throughout.
Does my third-party device need to be maintained before validation?
For devices from other manufacturers, the prescribed maintenance by the manufacturer or an authorized partner is a prerequisite for revalidation. After maintenance has been completed, we carry out the validation independent of the manufacturer on site.
Can a hot-air sterilizer be validated?
No, hot-air sterilizers generally cannot be validated and do not meet the RKI recommendations when reprocessing critical instruments. For standards-compliant reprocessing we recommend a Class B autoclave; we are happy to advise you.
Which documents are needed for a validation appointment?
Generally helpful are a current vacuum test protocol, a photo of the device including the type plate, and, where applicable, the initial validation report. Which documents are exactly needed for your case is something we clarify when arranging the appointment.
Is staff instruction included in the validation?
Yes, instruction is integrated on site during commissioning or initial validation. On request, we additionally offer training for your staff on safe reprocessing.
Can I order the initial validation directly together with the device?
Yes, you can order the initial validation directly with the device or commission it separately at any time afterwards. We arrange the appointment individually with you.
Why is validation not included in the device price?
Because validation must be carried out on site at the place of use with your instruments and cannot be part of the device shipment. It is therefore offered separately and can be ordered together or commissioned afterwards.
What does validation cost?
The costs depend on the device type, location and scope and are quoted individually on request. The combination of maintenance and revalidation at one appointment is usually more economical. We are happy to prepare a suitable offer for you.
What does a validation contract include?
A validation or maintenance contract bundles the regularly recurring services, organizes the appointments and ensures that your reprocessing remains permanently documented to standard and audit-proof. We discuss details and conditions individually.
Is the maintenance contract independent of the validation?
Yes, maintenance and validation are separate services and can be booked individually. However, it is sensible and usually more economical to have both carried out as a package at one appointment.
When should I conclude a validation or maintenance contract?
You can conclude the contract at any time after purchase; you do not have to do this immediately, but can wait until the maintenance is due. We are happy to advise you on the right time for your practice.
Can I present proof of validation for the authorities?
Yes. After validation you receive the validation report or confirmation that you can present to the public health office or during an inspection. If you have questions about presenting it, we will support you.
What does the validation check on my autoclave specifically?
During validation, calibrated sensors are used to check, among other things, the vacuum test, empty-chamber profile and several sterilization runs with your instruments. This proves that the process operates reproducibly and safely at the place of use.
How does Steri24 differ from established expensive providers in validation?
We validate independent of the manufacturer and offer a dense service network with our own service vehicles and fast on-site service in the DACH region, instead of a detour via the device manufacturer. This way you have a single point of contact for your entire reprocessing, often on fairer terms.
Do I need a separate validation for each device?
Yes, each device and each process is validated separately, since requirements and standards differ by device type. We offer the right validation for autoclave, thermal disinfector and sealing device respectively and bundle them into one appointment when needed.
Is only one program validated during initial validation?
Often one program is validated, which is sufficient for most practices. If you use several programs, we validate these additionally on request. We clarify in advance which scope is sensible for you.
How quickly do I get a validation appointment?
Availability depends on your region; thanks to our dense service network in the DACH region, appointments are generally possible promptly, often faster in larger cities. We agree the exact appointment individually with you.
Does Steri24 offer validation with its own technicians or via partners?
Both. We validate both with our own trained technicians and via certified service partners who operate on site in Germany, Austria and Switzerland. This way we are reachable for you across the board.
How do I book validation for my devices?
Select your device type in the selector, namely autoclave, thermal disinfector or sealing device, or request a callback. We advise you on the right scope, arrange the on-site appointment and handle the complete process including audit-proof documentation.