Package: Initial Validation + Commissioning · On site in Germany
Commissioning and initial validation — all from a single source.
Professional commissioning of your new thermal disinfector and the standard-compliant initial validation in one go — on site by certified Steri24 technicians. Installation, connection, training of your team and audit-proof documentation: your WD is ready to go right away.
Germany
To EN ISO 15883 Manufacturer-independent On site in Germany
Manufacturer-independent
We validate thermal disinfectors from all manufacturers.
No matter which manufacturer your device comes from — our certified technicians validate it properly. You don't need a second point of contact for your WD.
Tecno-Gaz (AquaPlus)AtosMiele
Your model isn't listed? No problem — on request we also service devices from other manufacturers. Please state the model of your thermal disinfector in the comment field of your order.
Legal certainty
Why validation is mandatory in Germany
Requirements in Germany
MPBetreibV · KRINKO/BfArM
Medical Devices Operator Ordinance (MPBetreibV): reprocessing only with suitable, validated procedures.
KRINKO/BfArM recommendation: automated cleaning & disinfection in the WD is to be preferred.
DIN EN ISO 15883-1/-2: requirements for performance and validation.
Annual revalidation (performance qualification) recommended; deviations must be justified in writing.
Technically sound: Thermal disinfection typically takes place at 90–95 °C. For the safe reprocessing of surgical instruments, an A₀ value of 3000 (equivalent to 90 °C for 5 minutes) is the benchmark.
Scope of services
What our validation delivers
Three qualification stages to EN ISO 15883 — fully documented and audit-proof.
Installation Qualification (IQ)
Inspection of installation, water, power and waste-water connections as well as the correct dosing technology.
Operational Qualification (OQ)
Verification of temperature curves, holding times and sensor technology with calibrated reference probes.
Performance Qualification (PQ)
Proof of cleaning and disinfection performance with real-world load patterns and soiling control (A₀ value).
Validation report & label
Complete, standard-compliant documentation to present during an inspection — plus a test label on the device.
Commissioning & training
Installation, connection of water/power/waste water and training of your team in safe operation.
Process
How your appointment works
From first contact to the audit-proof protocol — we coordinate everything and come to you.
1
Delivery & installation
We commission your new device on site: installation, connection and function check.
Phone · Form
2
IQ & OQ on site
The technician checks installation and operating parameters with calibrated measuring equipment — without bringing your operations to a standstill.
On site
3
Performance qualification
Several measurement cycles with real load patterns, temperature probes and soiling control.
EN ISO 15883
4
Evaluation & report
You receive the complete validation report with all measurement protocols — archivable in an audit-proof manner.
Documentation
5
Release & label
If the test is passed, we mark your device with a test label including the due date.
Release
6
Training & reminder
We train your team and make a note of the next revalidation for you.
Service
On site & in person
No shipping. No downtime.
Your thermal disinfector stays where it is — our technician comes to you in Germany with calibrated measuring equipment. That keeps your reprocessing ready for use and the impact on day-to-day practice minimal.