What does the exam mean in practice?
Type testing assesses whether a device meets the minimum design and functional requirements of its standards. This includes, for example:
Cleaning and…
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 10993-10 skin sensitization testing mean in practice?
Skin sensitization according to ISO 10993-10 assesses whether materials, additives, or extractable substances of a medical device…
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 10993-12 sample preparation mean in practice?
ISO 10993-12 defines the methodological foundation for all biocompatibility-related testing. It determines how samples must be selected,…
What does ISO 10993-18 chemical characterization mean in practice?
Chemical characterization under ISO 10993‑18 provides the analytical foundation for toxicological risk assessment. It determines…
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 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…
