Package: Revalidation + Maintenance · On site in Germany
Revalidation and maintenance — in a single appointment.
The complete package for your washer-disinfector (WD): revalidation and maintenance in a single on-site appointment. Less downtime, one point of contact, one appointment — and your thermal disinfector stays standard-compliant and reliably in service.
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 professionally. You need no second point of contact for your WD.
Tecno-Gaz (AquaPlus)AtosMiele
Available for Tecno-Gaz (AquaPlus), Atos, and Miele thermal disinfectors. Your model is not listed? No problem — on request we also service devices from other manufacturers. Please specify the model of your thermal disinfector in the order comments field.
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: machine 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 correct dosing technology.
Operational Qualification (OQ)
Verification of temperature curves, holding times and sensor technology with calibrated reference probes.
Performance Qualification (PQ)
Evidence of cleaning and disinfection performance with realistic load patterns and soiling control (A₀ value).
Validation report & label
Complete, standard-compliant documentation to present during inspections — plus a test label on the device.
Maintenance included
Safety- and wear-relevant components are checked in the same appointment in accordance with the manufacturer's specifications — less downtime.
Process
How your appointment works
From the first contact to the audit-proof protocol — we coordinate everything and come to you.
1
Arrange the appointment
You tell us the device, manufacturer and typical load. We coordinate revalidation and maintenance in a single visit.
Phone · Form
2
IQ & OQ on site
The technician checks the installation and operating parameters with calibrated measuring equipment — without bringing your operation 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 records — 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
Reminder for the next appointment
We get in touch in good time before the next due date — so you never miss a deadline.
Service
On site & personal
No shipping. No downtime.
Your thermal disinfector stays where it is — our technician comes to you directly in Germany with calibrated measuring equipment. This keeps your reprocessing ready for use and the impact on your daily practice routine minimal.