What does testing according to EN ISO 17664 mean in practice?
HygCen Germany checks exclusively whether the procedures described by the manufacturer are validatable – not whether they are sensibly designed or optimally formulated from a regulatory perspective.
We evaluate, for example:
- Can the specified RDG programs actually be validated according to EN ISO 15883 1/-2/-5?
- Do the described cleaning processes provide the required cleanliness tests (TOC, protein, hemoglobin)?
- Do the sterilization methods (e.g. steam) comply with the requirements of EN ISO 17665 1, EN 13060, EN 285?
- Can packaging information in the IFU be validated with ISO 11607-2 / EN 868 6 / ASTM F1608?
- Can microbiological testing requirements according to ISO 11737-1/-2 be met?
- Are the implant-specific requirements according to ISO 19227 met?
HygCen Germany is therefore testing the process, not the document.
Standard criteria – at a glance
| Standard criterion | Requirements / Content | Notice |
|---|---|---|
| Process steps | full manufacturer's information | We are checking their validation. |
| Validability | Procedures must be validatable according to standards. | e.g. RDG validation, sterilization |
| Device purchase | RDG programs (ISO 15883), Steri programs (ISO 17665-1) | Validation attempts |
| Cleaning certificates | TOC, Protein, Hemoglobin, ISO 19227 | Laboratory tests |
| Sterile barrier | ISO 11607-2, EN 868 6, ASTM F1608 | Barrier & Integrity Checks |
| microbiology | ISO 11737-1/-2 | Bioburden and sterility tests |
| documentation | QES-signed test reports | neutral, without any advisory component |
This is how we check the validatability of your ISO 17664 processes – step by step
Analysis of the processes described by the manufacturer:
We compare the specified steps with the requirements:- ISO 15883-1/-2/-5 (Cleaning/Disinfection)
- ISO 17665‑1 / EN 13060 / EN 285 (sterilization)
- ISO 11607-2, EN 868-6, ASTM F1608 (Packaging & Barrier)
- ISO19227 (Implant purity)
No evaluation of the IFU formulations – only validation of the described process .
Test planning:
We define the tests required to demonstrate validation:- RDG validation according to ISO 15883
- Purification test (TOC / Protein / Hemoglobin, according to ISO 15883-5 and ST98)
- Implant purity test (ISO 19227)
- Sterilization validation (ISO 17665‑1, EN 13060, EN 285)
- Packaging/barrier validation (ISO 11607-2, EN 868-6, ASTM F1608)
- Bioburden/Sterility (ISO 11737-1/-2)
We do not recommend a process , but only specify how the specified process will be reviewed.
Laboratory tests under realistic conditions.
We conduct the validation tests exactly according to the standard:- RDG cycles
- Quantitative cleanliness tests (TOC / Protein / Hemoglobin)
- Sterilization (e.g. steam , EO, H₂O₂ /plasma )
- Packaging tests
- microbiological tests
- Possibly end-of-life simulation (maximum reprocessing cycles)
Result: Validatable / not validatable .
- QES-signed test report.
Our report contains:
- Description of the audited process
- Results of all laboratory tests
- Statement on validation
- No IFU consultation, no assistance with wording.
- fully MDR-compliant
- independent, DAkkS-accredited testing laboratory
- 30 years of expertise in reprocessing validation
- Strictly neutral role (no IFU advice)
- QES signed reports
- Complete coverage of all standard components (RDG, sterilization, packaging, microbiology, implant cleanliness)
- Referral to external preparation/regulatory consultants possible
No. HygCen Germany assesses solely whether the reprocessing procedures described by the manufacturer are methodically validatable. The content, wording, or optimization of the Intake Functional Guidelines (IFU) is the manufacturer's responsibility and falls within the scope of independent regulatory consulting. Our task is to demonstrate the technical verifiability of the specified steps in accordance with the relevant standards – without influencing the IFU itself.
This depends on the process described in the IFU. Typical requirements include washer-disinfector validations according to ISO 15883, cleaning verification via TOC, protein, or hemoglobin, sterilization validations according to ISO 17665-1 or EN 13060/EN 285, and, if applicable, packaging tests according to ISO 11607-2 and microbiological tests according to ISO 11737-1/-2. For implants, additional cleanliness requirements according to ISO 19227 apply.
In this case, we neutrally document which process parameters or steps do not meet the requirements of applicable standards or do not produce reproducible results in the laboratory. The adaptation or redefinition of the process is the responsibility of the manufacturer or independent external consultants. HygCen Germany does not make any substantive recommendations but provides the test results as an objective basis for decision-making.
These parameters serve as quantitative evidence of whether the specified cleaning process achieves the required level of purity. Protein and hemoglobin are particularly relevant markers for invasive products, according to ISO 15883-5 and ANSI/AAMI ST98. TOC can be used for general cleaning performance and is established for implants according to ISO 19227. HygCen Germany exclusively verifies whether the processes defined in the IFU meet these criteria.
Validation should be re-evaluated whenever safety-relevant changes occur – such as new materials, modified manufacturing or sterilization processes, adjustments to the IFU, or updated standards. Clinical feedback or test results from bioburden or cleanliness studies can also prompt a re-evaluation of validation. The goal is to ensure that the currently described process remains compliant with standards and reproducibly validatable.
Further links
ISO 15883 - Waste Disposal Device Validation, 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