Laboratory testing services
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Biological testingBiological evaluation plan (BEP)
ISO 10993-1
A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, …
Face mask tests according to EN 14683 for type II and type IIR masks
EN 14683, ISO 10993-10, ISO 10993-5, …
We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN …
Genotoxicity - Bacterial reverse mutation test (AMES)
ISO 10993-3, OECD 471
The bacterial reverse mutation (AMES) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is …
Home compostability
ISO 11268-1, ISO 11268-2, ISO 14855, …
Home composting provides an effective way to manage organic waste on a small scale or within a household setting, involving the transformation of organic matter into compost through the activity …
Cytotoxicity testing by ISO 10993-5
ISO 10993-5
Cytotoxicity assessment is a crucial part of biocompatibility testing, which ensures that medical devices do not cause adverse reactions when in contact with the body. The assessment is required for new medical devices to be …
Irritation testing by ISO 10993-23
ISO 10993-23
ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed …
Pyrogenicity testing by ISO 10993-11
ISO 10993-11
Pyrogenicity assessment by ISO 10993-11 to evaluate the material-mediated pyrogenic (i.e., fever-inducing) potential of medical devices. Material-mediated pyrogenicity tests focus on non-endotoxin-related substances, …
Skin sensitization testing by ISO 10993-10
ISO 10993-10
Sensitization assessment by ISO 10993-10 is a crucial part of biocompatibility testing and one of the most common tests required to ensure the safety and compliance of medical devices. The goal is to show that …
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