Validation of Autoclaves – What You as a Practice Owner Need to Know
Do I need to have my autoclave validated?
Validation requirements, intervals and standards for Germany, Austria and Switzerland — explained clearly and to the point.
Germany Austria Switzerland
In short
Yes — anyone who reprocesses instruments used on humans (practice, clinic, podiatry, beauty, tattoo) must have their autoclave validated. The legal basis is § 8 MPBetreibV; validation is carried out every 24 months on site.
Validation: obligation, standards & procedure
Do I need to have my autoclave validated?
I am in Austria / Germany. Do I need to have my autoclave validated?
All users who reprocess instruments in human medicine (podiatry, beauty, tattoo studios, doctors, clinics....) are obliged to have their autoclave validated. The legal basis for the obligation to validate during instrument reprocessing is § 8 of the Medical Devices Operator Ordinance (MPBetreibV): Validation is carried out on site every 24 months in accordance with the national standard DIN SPEC 58929.You can order the initial validation in our shop (all-inclusive package price).
Please note that the autoclave must be revalidated every 2 years.
Tip: Conclude a validation contract with us. We take care of ensuring that your autoclave is always revalidated and remains ready for use. When you conclude a validation contract, you also receive a price advantage of 40 EUR per revalidation thanks to better plannability for on-site validation.
Statement from AGES:
Healthcare facilities, which also include resident dentists, are obliged under § 62 of the Medical Devices Act 2021 to carry out the cleaning, disinfection and sterilization of medical devices using suitable validated procedures, so that the success of these procedures is verifiably ensured. A validated (reprocessing) procedure requires properly qualified/validated devices (such as: cleaning and disinfection devices, autoclaves). Without prior device qualification/validation, the aim of validated procedures — namely to consistently deliver products (in this specific case: sterile medical devices) that meet the specified requirements — cannot be verifiably ensured.
This requirement is also reflected in various national guidelines, such as under 6.6 „Small sterilizers“ of the ÖGSV (Austrian Society for Sterile Supply)-LL 06-FK-2 (https://oegsv.com/wp/wp-content/uploads/06-FK-2_-Pruefung-und-Validierung-von-Aufbereitungsverfahren_2016.pdf) or the KRINKO BfArM recommendation, Bundesgesundheitsbl 2012 · 55:1244–1310, on p. 1251, third column.
I am in Switzerland. Do I need to have my autoclave validated?
All users who reprocess instruments in human medicine (podiatry, beauty, tattoo studios, doctors, clinics....) are obliged to have their autoclave validated. The legal basis for the obligation to validate during instrument reprocessing is the Medical Devices Operator Ordinance (MPBetreibV). Validation is carried out on site every 24 months in accordance with the recommendations of Swissmedic and is not included in the maintenance offer.I am in Switzerland, how often does my autoclave need to be revalidated?
Revalidation and maintenance of medical devices in Switzerland – standards and recommendations
The Swiss standards SN EN ISO 17665-1 and CEN ISO/TS 17665-2 are identical to the German counterparts DIN EN ISO 17665-1 and DIN ISO/TS 17665-2. These standards form the basis for the validation and revalidation of sterilization processes and are an essential component for ensuring the operational safety of medical devices.
Significance of revalidation according to KIGAP D5
As explained in the KIGAP D5 guideline (chapter "Re-assessment (revalidation)" on page 28), regular revalidation contributes significantly to increasing the operational safety and reliability of sterilization devices. It ensures that the devices continue to achieve the required sterilization effect over the long term under actual operating conditions.
Recommendations for revalidation according to CEN ISO/TS 17665-2
The standard CEN ISO/TS 17665-2 (chap. 12.4) recommends that revalidation should be carried out annually or in accordance with the manufacturer's specifications. Such a review ensures that the sterilization process continues to meet the required standards and that no deviations occur that could compromise safety.
Adjustment of revalidation cycles in Switzerland
In Switzerland there is a special feature: if the initial validation was carried out on the basis of the German standards, the revalidation can – depending on the manufacturer's specifications – also be carried out on a two-year cycle. This flexibility can be particularly advantageous for facilities that have already validated their processes according to the German standards.
Conclusion
Regular revalidation of medical devices is a decisive factor for safety and quality in sterilization. Companies and facilities should always take into account the recommendations of the standards as well as the manufacturer's specifications.
Further information and detailed notes can be found in the article Re-validation and maintenance cycle as well as service contracts for the devices in the Swiss QSS.
Benefit from the validation contract now:
You can order the initial validation in our shop (all-inclusive package price).
Please note that the autoclave must be revalidated every 2 years.
Tip: Conclude a validation contract with us. We take care of ensuring that your autoclave is always revalidated and remains ready for use. When you conclude a validation contract, you also receive a price advantage of 40 EUR per revalidation thanks to better plannability for on-site validation.
You can find all details on the requirements for healthcare facilities regarding instrument reprocessing here: Reprocessing (swissmedic.ch) Or contact us.
In Switzerland, at least one employee in the practice or clinic must be trained in instrument reprocessing. The following training courses are approved and recognized in Switzerland:
- H+ Bildung training course
- Specialist training course 1, 2, 3
- DGSV specialist and expert training courses
You don't have to handle this on your own
The most common concerns of our customers — and how we resolve them.
„Am I covered when the authorities come?“
Audit-proof validation reports and a reminder service keep you permanently on the safe side.
„Downtime until the appointment?“
We schedule the validation around your ongoing operations — without any practice shutdown.
Legally secure through every inspection.
Initial and revalidation on site throughout the DACH region — audit-proof documentation. No one has ever failed with us.
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Frequently Asked Questions
Validation info – key questions answered clearly.
Do I need to have my autoclave validated?
Yes. Anyone who reprocesses instruments used on humans (podiatry, beauty, tattoo/piercing studios, medical and dental practices, clinics) is obliged to have the autoclave validated. In Germany the legal basis includes Section 8 of the Medical Devices Operator Ordinance (MPBetreibV).
What does validation of an autoclave mean?
Validation is a formal assessment that demonstrates that your autoclave and the entire reprocessing process meet the applicable standards and sterilize reliably. It is carried out on site using your instruments as the load and is documented.
Is validation mandatory in Germany?
In Germany, validation is mandatory for everyone who reprocesses medical instruments used on humans (e.g. podiatry, beauty, tattoo/piercing studios, doctors, clinics). The legal basis includes the MPBetreibV. Anyone who does not reprocess critical instruments that come into contact with blood is usually not obliged to do so.
When is the initial validation of the autoclave mandatory?
An initial validation is mandatory as soon as you sterilize critical instruments, i.e. instruments that penetrate skin or mucous membranes or come into contact with blood or sterile medicinal products. It must be carried out on site in your practice.
How often does the autoclave have to be validated?
Validation is generally due every 24 months (2 years). With smooth operation of a Class B autoclave, this interval can be used in full; larger devices or a high number of cycles may require earlier revalidation.
At what interval must revalidation take place?
Revalidation is generally due every 2 years or after around 1,000 cycles and is carried out on site. Larger devices or high utilization may mean shorter intervals.
How does the validation work or what is done during it?
During validation, the autoclave and reprocessing process are assessed on site: using sensors, a vacuum test, an empty-chamber profile and several sterilization runs with your instruments as the load are carried out, among other things. You then receive a validation report.
Why must validation be carried out on site?
Because validation tests the actual conditions at the place of use, i.e. the installation, the load with your instruments and the real process. Sending the device to the factory is not possible for this; a device that is sent in can be serviced, but not validated.
Who is allowed to carry out the validation, can I do it myself?
Validation must be carried out by an approved validator with the appropriate measuring equipment and is practically not possible to do yourself. Steri24 handles the entire process on site; in principle, another approved provider can also carry it out.
What is the difference between validation and maintenance?
Maintenance is the technical servicing of the device with the replacement of wearing parts. Validation is the formal assessment that the entire sterilization process meets the standards and functions reliably. Both are separate, regularly recurring services.
Is the maintenance contract independent of validation?
Yes, maintenance and validation are separate services and can be booked individually. It is sensible and usually cheaper to have both carried out as a package during a single appointment.
Does the autoclave have to be validated even with low usage?
Yes. The validation or revalidation interval is time- and cycle-dependent (generally every 24 months or after around 1,000 cycles) and applies regardless of actual usage, as long as you reprocess critical instruments.
Is validation mandatory for a foot care or podiatry practice?
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 omitted, but it can be carried out at any time afterwards.
Does the autoclave have to be validated in the veterinary field?
In the purely veterinary field, validation is not legally required, since the obligation only applies to the reprocessing of instruments used on humans. A voluntary validation is of course possible.
Does the autoclave have to be validated 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.
What are critical instruments in terms of the validation obligation?
Critical instruments are those that penetrate skin or mucous membranes or come into contact with blood or sterile medicinal products. Validated procedures and therefore a validated autoclave are required for their reprocessing.
How long after purchase must the initial validation take place?
The initial validation should be carried out promptly after commissioning in a separate appointment on site. You can generally already use the device after delivery; we coordinate the exact deadline and appointment individually with you.
Is the device already usable before validation?
Yes. The initial validation is a process validation and can also be carried out after commissioning, so the autoclave is generally ready for use after delivery and setup. Validation can be commissioned at any later point in time.
Can I also carry out the validation later?
Yes, the initial validation can also be carried out after commissioning. However, please note that a validated procedure is required for the reprocessing of critical instruments; feel free to contact us for a prompt appointment.
Can I buy an autoclave without validation?
Yes, you can also order the autoclave without validation and commission it yourself in accordance with the manual. Whether validation is mandatory depends on your area of use; it can be added at any time later.
Why is the autoclave offered without validation, even though it may be mandatory?
Validation must be carried out on site at the place of use and is therefore not part of the device shipment. It is therefore offered separately and can be ordered directly with the device or commissioned afterwards.
Can I order the initial validation directly with the autoclave?
Yes, you can order the initial validation directly with the autoclave or commission it separately at any time afterwards. We arrange the appointment individually with you.
Why does a new device have to be validated, isn't it tested at the factory?
Even a device tested at the factory must be validated at the place of use, because validation tests the actual conditions on site (installation, load, process). This is not possible at the factory, which is why the initial validation must take place on site.
Does a used or refurbished device have to be revalidated?
Yes, a used or refurbished device should also be initially validated at the new place of use and then revalidated regularly, since validation tests the conditions on site.
Can I carry out the setup and commissioning myself, but not the validation?
You may carry out the setup and commissioning yourself according to the manual; on request, our technicians will also do this on site. However, validation must be carried out by an approved validator.
Can you also validate third-party devices from other manufacturers?
We generally cannot service third-party devices from other manufacturers, but we can validate them. The prerequisite is that the prescribed maintenance has previously been carried out by the manufacturer or an authorized partner. Send us the model and manufacturer, and we will prepare a quote.
Do you handle the maintenance and validation of the device purchased from you?
Yes, we handle the maintenance and validation of the devices purchased from us, including installation and initial validation on site and, on request, as part of a maintenance or validation contract.
What is a validation contract and what advantages does it offer?
With a validation contract, we take care of ensuring that your autoclave is always revalidated on time and remains ready for use. When you conclude one, you also receive a price advantage of 40 EUR per revalidation thanks to better plannability for the on-site appointment.
When and how do I conclude a maintenance or validation contract?
You can conclude the contract at any time after purchase; you do not have to do this immediately when buying. You can find the template on steri24.de; the combination of maintenance and revalidation on a single day is usually cheaper.
Does someone come to me on site for the revalidation?
Yes, the revalidation is carried out on site at your premises; in Germany, Austria and Switzerland the travel is free of charge. We arrange the appointment individually with you.
Will you remind me of the due revalidation?
Yes. With our reminder service or a validation contract, we keep track of the due date, contact you in good time and arrange the on-site appointment, so that you remain permanently on the safe side.
Does Steri24 offer maintenance and validation itself or through partners?
We offer maintenance and validation both with our own trained technicians and through service partners who work on site in Germany, Austria and Switzerland.
Do I have to expect a practice shutdown for the validation?
No. We schedule the validation around your ongoing operations, so that no practice shutdown is necessary. We coordinate the appointment so that it fits as smoothly as possible into your workflow.
Which documents are needed for a validation appointment?
As a rule, we need a current vacuum test protocol, a photo of the autoclave including the type plate and, if applicable, the report of the initial validation. Please send these to support@certoclav.com; we will then arrange the appointment with you.
What proof do I receive after the validation?
After the validation you receive an audit-proof validation report. You can present this during an inspection by the health authority, as it documents the conformity of your reprocessing process.
Am I covered with the validation during an inspection by the authorities?
Yes. Audit-proof validation reports and a reminder service keep you permanently on the safe side. We carry out initial and revalidation throughout the DACH region with audit-proof documentation.
Can sealing devices also be validated?
Yes, validatable sealing devices such as the CertoSeal range can be validated in accordance with the applicable requirements. In Germany, the validation of the sealing process is indirectly mandatory via standards and the MPBetreibV.
Can thermal disinfectors or washer-disinfectors be validated?
Yes, our validation is a process validation of the entire reprocessing process and is offered for autoclaves, validatable sealing devices and thermal disinfectors or washer-disinfectors.
Can a hot-air sterilizer be validated?
No, hot-air sterilizers generally cannot be validated. In addition, they do not meet the relevant recommendations for the reprocessing of critical instruments that come into contact with blood.
With the package 'Initial validation on site - 1 program', is only one program validated?
Yes, with this package one program is validated. This is sufficient for the vast majority of our customers; if several programs are needed, we will advise you on the appropriate variant.
Do I need to have my autoclave validated in Austria?
Yes. Healthcare facilities, including resident dentists, are obliged under Section 62 of the Medical Devices Act 2021 to carry out cleaning, disinfection and sterilization using suitable validated procedures. A validated procedure requires a validated device.
On what basis is the validation obligation in Austria founded?
In addition to Section 62 of the Medical Devices Act 2021, corresponding requirements can be found in national guidelines, for example under point 6.6 'Small sterilizers' of the OEGSV guideline as well as in the KRINKO BfArM recommendation. These require properly qualified and validated devices.
Do I need to have my autoclave validated in Switzerland?
Yes. All users who reprocess instruments in human medicine are obliged to have their autoclave validated. Validation is carried out on site in accordance with the recommendations of Swissmedic.
How often does my autoclave have to be revalidated in Switzerland?
The relevant standard recommends annual revalidation or in accordance with the manufacturer's specifications. However, if the initial validation was carried out on the basis of the German standards, the revalidation can also be carried out on a two-year cycle, depending on the manufacturer's specifications.
Which standards apply to validation in Switzerland?
The Swiss standards SN EN ISO 17665-1 and CEN ISO/TS 17665-2 are identical to the German counterparts DIN EN ISO 17665-1 and DIN ISO/TS 17665-2. They form the basis for the validation and revalidation of sterilization processes.
Does personnel for instrument reprocessing have to be trained in Switzerland?
Yes, in Switzerland at least one employee in the practice or clinic must be trained in instrument reprocessing. Approved specialist training courses are recognized; we will be happy to advise you on the appropriate training.
Why is the initial validation not sufficient and a revalidation necessary?
Regular revalidation ensures that the sterilization process continues to achieve the required sterilization effect over the long term under real operating conditions and that no safety-relevant deviations occur. It thus permanently increases operational safety.
What steps make up a complete validation?
A validation typically comprises installation qualification, operational qualification and performance qualification, supplemented by periodic and batch-related routine tests. In this way, the entire reprocessing process is verifiably secured.
Which routine tests do I have to carry out myself between validations?
Between validations, periodic and batch-related routine tests are provided, such as the daily vacuum test and the monitoring of the process parameters of each batch. These supplement the validation and are part of ongoing quality assurance. The details are set out in your validation protocol.
How much does the validation of my autoclave cost?
The costs depend on the location, device and selected package. The initial validation is offered as an all-inclusive package price, and with a validation contract you also receive a 40 EUR price advantage per revalidation. We will be happy to prepare an individual quote for you; request the validation via the shop or the advisory service.