ISO 22196 (formerly JIS Z 2801) testing is essential to independently demonstrate the antibacterial activity of products such as surface materials, medical devices, packaging and household…
What does packaging validation mean in practice?
Packaging must be suitable for use throughout the entire life cycle of the product:
sterility-preserving mechanically stable thermally, chemically…
Type testing under realistic test conditions
A type test is more than a formal standard check. The crucial factor is whether a processing device delivers the required performance under defined,…
What does an End of Life test mean in practice?
An end-of-life test simulates the complete life cycle of a product from a reprocessing perspective:
repeated cleaning (manual/washer-disinfector)…
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…
What is being tested?
HygCen Germany tests all components required for standards-compliant validation in a neutral and reproducible manner.
Cleaning performance
Quantitative tests: …
What does validation according to ISO 17665-1 mean in practice?
Validation describes whether a sterilization process:
the required sterilization effectiveness is achieved (e.g. via defined…
What does cleaning validation mean in practice?
In practice, cleaning validation answers the question of whether the described cleaning process—manual or washer-disinfector-assisted—reproduces…
What does testing according to ISO 11737 1/-2 mean in practice?
In practice, the combination of bioburden and sterility tests answers several key questions:
What is the initial microbiological…
What does ISO 10993-12 sample preparation mean in practice?
ISO 10993-12 defines the methodological foundation for all biocompatibility-related testing. It determines how samples must be selected,…
