What is being tested?
HygCen Germany tests all components required for standards-compliant validation in a neutral and reproducible manner.
Cleaning performance
- Quantitative tests:
Protein, hemoglobin, TOC - Additionally: visual assessment, residual load analysis
- defined soiling according to ASTM F3208-20, AAMI methods, EN requirements
- Examination of machine and manual steps
Effectiveness of disinfection
- bactericidal, fungicidal/yeasticid, virucidal, possibly sporicidal
- Reduction values according to EN 14885 (e.g. ≥ 4 lg reduction depending on the area of application)
- Thermal effectiveness according to ISO 15883 (A₀ assessment )
- chemical / chemothermal processes according to standard
methods
- Process simulation under realistic conditions
- machine cycles (cleaning/disinfection)
- manual cleaning steps according to AAMI TIR12 / ST98
- quantitative laboratory analyzes (protein/Hb/TOC)
- Validation of the reduction performance
Interfaces to ISO 17664
- We check whether the steps specified by the manufacturer in the IFU have been followed:
- technically verifiable,
- feasible under practical conditions
- can be validated according to standards .
Standard criteria – at a glance
| Standard criterion | Requirements / Content | HygCen test |
|---|---|---|
| ISO 15883-5 | Requirements for cleaning and machine disinfection | RDG validation, cleaning certificates, process simulation |
| EN 14885 | Efficacy requirements for chemical disinfection | Proof of ≥ 4 lg reduction (depending on spectrum of activity) |
| AAMI TIR12 | Manual cleaning & disinfection | manual process simulation, quantitative cleanliness checks |
| AAMI ST98 | Cleaning Validation | Worst case contamination, protein/Hb/TOC detection |
| ASTM F3208 20 | Standard Soil for cleaning tests | defined soiling for reproducible tests |
Test procedure – step by step
- Process analysis
Comparison of manufacturer's specifications with:
ISO 15883 (RDG), EN 14885 (disinfection), AAMI TIR12 / ST98 (manual cleaning), ASTM F3208-20 (soiling). - Selection of test methods
Definition of the necessary tests for cleaning and disinfection:
- quantitative cleanliness parameters (protein/Hb/TOC)
- manual / machine testing cycles
- Efficacy evidence according to EN 14885
- Cleaning tests (machine & manual)
- RDG cleaning tests according to ISO 15883
- manual cleaning according to AAMI TIR12 / ST98
- Assessment via quantitative residual contamination analysis
- Worst-case simulations
- Disinfection effectiveness
- thermal effectiveness (A₀)
- chemical and chemothermal processes
- Reduction verifications according to EN 14885 (e.g. ≥ 4 lg reduction )
- Testing realistic stress conditions
- QES-signed test report
- Description of the audited process
- Laboratory results of all tests
- Statement on validatability (validable / not validatable)
- neutral, without any advisory component
- MDR-compliant and testable
Why HygCen?
- DAkkS-accredited testing laboratory (DIN EN ISO/IEC 17025) and GLP-compliant processes
- Risk-based test planning tailored to contact type, exposure duration, and application
- Testing in original condition – including relevant process, sterilization, or reprocessing influences
- Digital, QES-signed test report with expert classification for technical documentation/MDR
No. HygCen Germany solely assesses whether the cleaning and disinfection process specified by the manufacturer is methodically validatable . We do not optimize parameters, select chemicals, or provide recommendations for process design. These tasks remain entirely with the manufacturer or external consultants. Our role is strictly neutral.
The relevant standards (ISO 15883, AAMI ST98, AAMI TIR12) require quantitative residual contamination testing. This includes, in particular:
- protein
- hemoglobin
- TOC
- Visual assessment and additional analysis may be required.
The tests demonstrate whether the manufacturer's specified process reproducibly achieves the required purity limits. HygCen Germany tests exclusively for testability , not process optimization.
The assessment is based on the requirements of EN 14885 and the associated efficacy standards. Depending on the spectrum of activity, a minimum reduction of ≥ 4 lg (bactericidal, fungicidal, virucidal) or higher reduction values are required. For thermal processes, efficacy is assessed according to ISO 15883 using A₀ values. We conduct an independent review to determine whether the specified process meets these requirements.
In this case, we document the following in the QES report:
- which steps do not meet the standard requirements,
- which reduction or purity values were not achieved in the laboratory,
- Which parameters prevent reproducibility?
The manufacturer bears full responsibility for process adjustments. HygCen Germany does not offer any suggestions or alternatives.
ISO 17664 specifies which reprocessing steps the manufacturer must describe.
The validation of the cleaning and disinfection process checks whether these steps are technically validatable.
We test the process – not the IFU (Inspection Unit).
A repeat visit is necessary if:
- materials change
- Cleaning/disinfecting agents should be changed.
- Devices or parameters can be adjusted.
- Standards have been updated
- Anomalies may occur during clinical use. The goal is to ensure that the process remains reproducibly validatable
under current conditions .
Further links
ISO 17664 - Validation of manufacturer's specifications, ISO 17665-1 / EN 13060 / EN 285 - Sterilization Validation, Cleanliness Verification - TOC / Protein / Hemoglobin / ISO 19227, End of Life - Material and Functional Durability, Bioburden & Sterility - ISO 11737-1/-2, Type Testing of Reprocessing Equipment, Packaging & sterile barrier – ISO11607-2, Reprocessing of medical devices