Law and Obligations
Law & obligations in instrument reprocessing
Validation, documentation, RKI: here you will find a clear explanation of what you really have to do — and how to pass every inspection with confidence.
Germany Austria Switzerland
In short
Anyone who reprocesses instruments used on humans is subject to the MPBetreibV. In practice this means: validate, document correctly and reprocess according to RKI. The following pages guide you safely through every point.
Your obligations — clearly explained
Choose your topic. Each page answers the most common questions from real practices.
Information on validation
Who must validate, how often, and to which standard — DE / AT / CH.
Learn moreInstrument reprocessing according to RKI
The complete reprocessing cycle according to RKI — step by step.
Learn moreDocumentation of instrument reprocessing
Batch control, release and audit-proof documentation done right.
Learn moreTests & indicators
Helix, indicator, spore test — which test for which instruments.
Learn moreInformation on the warranty
2 or 3 years of warranty? What is covered — and what is not.
Learn moreYou do not have to manage this alone
The most common concerns of our customers — and how we solve them.
„Am I even required to validate?“
We will tell you honestly whether and what you need — and get you through every inspection with legal certainty.
„Is my documentation enough for the authorities?“
With audit-proof, paperless documentation you can prove every batch without any gaps.
Legally compliant through every inspection.
Initial and revalidation on site throughout the DACH region — documented in an audit-proof way. With us, no one has ever failed.
What our customers say
4.9 out of 5 stars on Google — from verified reviews.
MK
Maud Kolb · Google
„Fast delivery, good advice, great price. Maintenance and validation nearby. I am happy. Thank you!“
SG
Stephanie Grebe · Google
„I am very positively impressed by the very good, honest, patient advice. You feel well looked after.“
4.9 out of 5 on Google Class B medical device · EN 13060 · TÜV SÜD 39 locations + 150 partners DACH Family business since 1957
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Frequently Asked Questions
Frequently asked questions – key questions answered clearly.
When is validation of the autoclave mandatory?
Validation is mandatory as soon as you reprocess critical instruments used on humans, i.e. instruments that penetrate skin or mucous membranes or come into contact with blood. The legal basis includes the MPBetreibV. Anyone who does not reprocess critical instruments is usually not required to validate.
What does validation of an autoclave mean?
Validation is a formal test that proves your autoclave and the entire reprocessing process meet the applicable standards and sterilise reliably. It is carried out on site using your instruments as the load.
How often must the autoclave be validated?
Revalidation is generally due every 2 years; with the smooth operation of a Class B autoclave this interval can usually be used in full. Larger devices or a high number of cycles may require earlier revalidation.
Must the initial validation always be carried out on site?
Yes, the validation must be carried out on site with your instruments as the load, because it tests the actual conditions at the place of use. Shipping the device to the factory for this is not possible.
How does a validation work?
During validation, the autoclave and reprocessing process are assessed on site: using measuring sensors, this includes a vacuum test, an empty-chamber profile and several sterilisation runs with your instruments. Afterwards you receive a validation report.
Can I carry out the validation myself?
No, the validation must be carried out by an approved validator, as special measuring equipment is required for this. However, according to the manual you may handle the setup and commissioning yourself.
How soon after purchase must the initial validation take place?
The initial validation should take place promptly after commissioning and is carried out at a separate on-site appointment. You can already use the device after delivery; the initial validation can also be done later.
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 done later at any time.
Does the autoclave have to be validated in the veterinary field?
In the purely veterinary field, validation is not required by law, as the obligation only applies to the reprocessing of instruments used on humans. A voluntary validation is of course possible.
Can you validate or service devices from other manufacturers?
As a rule, we cannot service third-party devices, but we can validate them. The prerequisite is that the prescribed maintenance was previously carried out by the manufacturer or an authorised partner. Send us the model and manufacturer and we will prepare a quote.
Can I buy the 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 later at any time.
Can validation also be done later, and is the device usable beforehand?
Yes. The initial validation is a process validation and can also be carried out after commissioning. The autoclave is therefore ready for use immediately after delivery.
Do you handle maintenance and validation of the device purchased from you?
Yes, we handle the maintenance and validation of devices purchased from us, including on-site installation and initial validation and, if desired, as part of a maintenance contract.
Do your technicians come on site for validation and service?
Yes, throughout the DACH region we have trained technicians and service partners who come on site for installation, validation, maintenance and repair. The call-out is free of charge.
Can sealing devices also be validated?
Yes, all our devices, including validatable sealing devices such as the CertoSeal, can be validated in accordance with the requirements that apply at national and federal-state level.
What documentation and validation obligations apply to the sealing device?
The requirements may vary depending on the responsible chamber, e.g. a daily seal seam test and an annual validation with a seal seam strength test. The seal seam test is only required if you seal critical medical devices for use on humans.
What is the MPBetreibV and who does it apply to?
The Medical Devices Operator Ordinance (MPBetreibV) governs the operation and use of medical devices. It applies to everyone who reprocesses instruments used on humans and requires, among other things, validated procedures and correct documentation.
How does instrument reprocessing according to RKI work step by step?
Reprocessing according to RKI takes place in several steps: first the risk assessment of the instruments, then preparation and pre-cleaning, cleaning, disinfection, drying, packaging, sterilisation and finally release. You will find details in the knowledge article on instrument reprocessing according to RKI.
How are instruments classified into risk classes according to RKI?
According to RKI and KRINKO, instruments are classified as non-critical, semi-critical and critical. Critical A refers to instruments without hard-to-reach areas, critical B to those with cavities or joints, critical C to special manufacturer requirements. A list from the responsible chamber helps with classification.
When is machine cleaning mandatory?
For non-critical and semi-critical instruments, manual or machine cleaning is possible. For critical instruments, machine cleaning is mandatory: for critical A an ultrasonic cleaner is sufficient, for critical B a thermal disinfector (washer-disinfector) is required.
Is a thermal disinfector mandatory in Germany?
A thermal disinfector is not generally mandatory in Germany, but in combination with the MPBetreibV and RKI recommendations it is in fact strongly recommended. For critical B instruments with cavities a washer-disinfector is required.
Do hot-air sterilisers meet the RKI requirements?
No, hot-air sterilisers can generally not be validated and do not meet the RKI recommendations for reprocessing critical instruments. A Class B steam steriliser is required for critical instruments.
How quickly must instruments be cleaned after use?
According to KRINKO and RKI, cleaning should take place as soon as possible after use to prevent blood and tissue from drying on. Place critical instruments directly after use in a closed transport box in the unclean area.
Do instruments have to be cleaned before sterilisation?
Yes, instruments must be cleaned before sterilisation and, depending on their classification, disinfected. Thorough cleaning is the basic prerequisite for safe sterilisation, as residues jeopardise its success.
Which instruments must be packaged for sterilisation?
Critical instruments that come into contact with blood or penetrate skin/mucous membranes must be sterilised packaged. Non-critical and semi-critical instruments may be sterilised unpackaged.
What documentation is required for sterilisation?
In addition to the steri protocol, you need documentation in accordance with RKI, with labelling and traceability for critical instruments. For sets and trays, illustrated tray lists with a sample load are also required.
How is batch release documented and what must it contain?
Batch release must be documented according to RKI, either by hand using a batch release form and a sterilisation pen, or digitally with SteriTrace. For critical instruments there is also a batch tracking and labelling obligation.
Where can I find templates and forms for documentation and batch release?
We provide free templates for documentation and batch release, e.g. a handwritten batch release form as well as a detailed knowledge document in the wiki at steri24.de. Alternatively, digital documentation via SteriTrace is possible.
How long must sterilisation and release records be kept?
The retention periods vary depending on the legal basis: at least 5 years according to RKI, up to 10 years under the StGB and up to 30 years under the BGB. We recommend keeping all documentation for 30 years, ideally digitally.
Must indicator and helix test strips be kept?
Indicator, batch and sterile strips, including helix test strips, no longer have to be kept long-term. However, the batch release itself must still be documented.
When must the batch number and sterilisation pouches be labelled?
Always after sterilisation. At least the batch number must be written on the packaged instruments, ideally with a sterilisation pen free of toxic chemicals. Tracing labels are also applied after sterilisation.
How is the batch number assigned?
The batch number is a consecutive number that increases by one with each program run of an autoclave, thermal disinfector or sealing device. The batches must remain traceable so that complete traceability is possible.
Is a helix test mandatory and when is it needed?
A helix test checks steam penetration for hollow-body instruments and is used for packaged critical instruments. For unpackaged semi-critical or critical A instruments, a Class 5 steam indicator is sufficient according to RKI and KRINKO.
Which indicator is sufficient for unpackaged instruments?
For unpackaged instruments of the semi-critical A or critical A category, a Class 5 steam indicator placed in with the load is sufficient according to RKI and KRINKO. A helix test is not required here.
What is a vacuum test and why is it important?
The vacuum test checks the tightness of the chamber and is a prerequisite for safe steam penetration. If it fails, this usually indicates a leaking door seal that needs to be readjusted or replaced.
May the loading and release of the batch be carried out by different people?
Yes, loading and release may be carried out by different people. The only important thing is that the release is performed by a trained and competent person, as recommended by KRINKO.
Does every staff member need expertise training?
If at least one person has completed the expertise training, this is usually sufficient for the entire practice. In your absence, a trained colleague may handle documentation and execution, provided she has the necessary knowledge.
Does the autoclave create the sterilisation records itself?
Yes, the autoclaves log every cycle automatically. On the Pro models the output is via an integrated printer or USB, on the Premium models digitally and paperless via SteriTrace.
What does paperless documentation mean?
Paperless documentation means that all relevant sterilisation data is recorded and stored digitally, without the need for a paper printout. The data is stored, for example, on the memory card, the USB stick or in the practice software.
What is SteriTrace and what is it used for?
SteriTrace is a digital tool for the complete, traceable documentation and batch tracking of sterilisation processes in accordance with the KRINKO recommendation. It enables the electronic recording and management of sterilisation data without printer paper.
Can I carry out the batch release directly on the autoclave?
Yes, with the Premium autoclave you can carry out and document the batch release according to RKI directly on the touchscreen, either by signature or password.
Can the autoclave be connected to my practice or hygiene software?
Yes, the Premium autoclaves in particular can be connected to common practice and documentation software via LAN/WLAN or a serial interface. The output protocol is compatible with common formats; our technician handles the setup.
Does the Steri24 autoclave meet the RKI requirements?
Yes, the Steri24 Class B autoclave complies with the applicable guidelines according to EN 13060 and can be validated in accordance with the MPBetreibV and RKI. All documents and certificates are available for download with the product in the shop.
How long is the warranty on the devices?
The standard warranty is 2 years. On autoclaves we grant up to 3 years of warranty, provided the prescribed maintenance is carried out at the specified interval. You will find the exact conditions with the respective product in the shop.
What does the warranty cover and what does it not?
The warranty covers material and functional defects and, depending on the variant, includes free repair as well as a loan device. Normal wear parts and damage caused by improper use are not covered. Please refer to the warranty conditions for details.
What is the prerequisite for extending the warranty?
The prerequisite for the extended warranty is that the prescribed maintenance is carried out at the specified interval. A free maintenance contract can secure this; we will gladly tell you the exact conditions.
What is the benefit of a maintenance contract with regard to obligations?
A maintenance contract secures the prescribed maintenance work and can extend the warranty. We remind you of deadlines in good time, arrange the appointment and take care of the work, spare parts and report, so that you keep track of all obligations.
Do you offer documentation and advice on reprocessing?
As part of validation and maintenance you receive the associated documentation, e.g. the validation report. For the ongoing documentation of reprocessing, we are happy to advise you on suitable solutions such as SteriTrace.
How do I pass a hygiene inspection by the authorities?
For an inspection you need a validated procedure, a correct risk classification of your instruments and complete, audit-proof documentation of every batch. With paperless documentation and full validation you can demonstrate all obligations; we are happy to support you with this.
How does Steri24 differ from established expensive manufacturers when it comes to law and obligations?
Our Class B autoclaves according to EN 13060 meet the same regulatory requirements as significantly more expensive devices from established providers, but at fairer prices and with a large on-site service network throughout the DACH region for validation and maintenance.