BS EN ISO 10993-11:1996 - Biological evaluation of medical devices - Tests for systemic toxicity
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BS EN ISO 10993-11:1996 is a standard within the ISO 10993 series that addresses the biological evaluation of medical devices. In particular, this standard focuses on tests for systemic toxicity related to medical devices.
Here are some key points regarding BS EN ISO 10993-11:1996:
The standard provides guidelines and methods for conducting tests to assess the potential systemic toxicity of medical devices. Systemic toxicity refers to the potential of a substance or material to cause adverse effects throughout the body when it is absorbed or distributed systemically.
Biological Evaluation: Assessing the systemic toxicity of a medical device is an essential component of the biological evaluation process. It helps ensure that the device does not release harmful substances or cause systemic reactions when used in a clinical setting.
Testing Methods: BS EN ISO 10993-11:1996 outlines specific testing methods and procedures for evaluating systemic toxicity. These methods may include in vivo tests conducted on animals, such as rodents, to assess the effects of the device or its extracts when introduced into the body.
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 pose risks to systemic health.
Risk Assessment: The results of systemic toxicity testing are used to assess the potential risks associated with the use of medical devices. Manufacturers rely on this information to design and produce devices that are safe for use and do not cause systemic harm.
Safety Assurance: The primary goal of this standard is to assure the safety of medical devices by evaluating their potential for systemic toxicity. This helps manufacturers make informed decisions about device materials, design, and usage to minimize these risks.
