BS EN ISO 10993-10:1996 - Biological evaluation of medical devices - Tests for irritation and sensitization
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BS EN ISO 10993-10:1996 is a standard that falls within the field of biological evaluation of medical devices. Specifically, this standard focuses on tests for irritation and sensitization related to medical devices.
Here are some key points regarding BS EN ISO 10993-10:1996:
The standard outlines guidelines and methods for conducting tests to evaluate the potential for medical devices to cause irritation and sensitization in living tissues. Irritation refers to the localized inflammatory response, while sensitization involves an allergic or immune response to a substance.
Biological Evaluation: Biological evaluation is a critical aspect of assessing the safety of medical devices before they are used on patients. Ensuring that medical devices do not cause irritation or sensitization is essential to prevent adverse reactions in individuals who come into contact with the devices.
Testing Methods: BS EN ISO 10993-10:1996 provides specific test methods for evaluating irritation and sensitization potential. These methods may include tests using animal models or in vitro (cell-based) testing to assess the effects of the device or its extracts on tissues.
Biocompatibility Assessment: The standard is part of a broader series of ISO 10993 standards that address various aspects of biocompatibility testing for medical devices. Biocompatibility assessments aim to ensure that medical devices are compatible with the human body and do not cause harm.
Risk Assessment: The results of irritation and sensitization testing are used to assess the potential risks associated with the use of medical devices. Manufacturers use this information to design and produce devices that are less likely to cause adverse reactions.
Safety Assurance: The primary goal of this standard is to ensure the safety of medical devices by evaluating their potential to cause irritation and sensitization in patients. It helps manufacturers make informed decisions about device materials and design to minimize these risks.
