Why HygCen?
Accredited testing laboratory (EN ISO/IEC 17025) – with lists available for flexible scope. All claims from a single source – including special requirements (MRSA,…
What does the cycle "from patient to patient" mean?
The term "from patient to patient" describes the idea that a medical device should be at least as safe to use after each reprocessing cycle as it…
Overview of Our Projects
Development of sustainable testing methods in the “Green Laboratory” Studies on the effectiveness of innovative disinfection processes Collaborations within the framework of…
What does ISO 10993-5 cytotoxicity testing mean in practice?
Cytotoxicity according to ISO 10993-5 is the earliest and most fundamental biological safety indicator within the ISO 10993 testing…
What does the biological evaluation under ISO 10993-1 mean in practice?
Biological evaluation according to ISO 10993-1 is not a single test, but a risk-based process in which chemical, biological,…
What does ISO 10993-11 systemic toxicity testing mean in practice?
ISO 10993‑11 evaluates systemic toxicological effects and is a key component of the ISO 10993‑1 Biological Evaluation. While…
What does ISO 10993-4 hemocompatibility testing mean in practice?
ISO 10993‑4 assesses how a medical device interacts with blood and whether hemolytic, coagulation‑related or immunological reactions…
What does ISO 10993-3 genotoxicity testing mean in practice?
ISO 10993‑3 assesses potential genotoxic risks of a medical device and forms a key component of the ISO 10993‑1 Biological Evaluation.…
What does ISO 10993-23 irritation testing mean in practice?
ISO 10993-23 assesses the irritant potential of a medical device and is therefore a key component of biosafety. Modern irritation tests…
What does ISO 10993-10 skin sensitization testing mean in practice?
Skin sensitization according to ISO 10993-10 assesses whether materials, additives, or extractable substances of a medical device…
