Chemical Characterisation & TRA
Chemical Characterisation Test (ISO 10993-18) and Toxicological Risk Assessment (ISO 10993-17) are important steps in evaluating the safety and compatibility of medical devices with the human body. These processes are outlined in international standards to ensure that devices do not pose harmful risks to patients.
Chemical Characterisation Test (ISO 10993-18):
ISO 10993-18 provides guidelines for assessing the chemical composition of a medical device and its potential impact on human health. This involves identifying and quantifying the substances present in the device's materials and evaluating their potential to leach or interact with the body. By performing chemical characterisation tests, manufacturers can gain insights into any potential risks arising from chemical exposure.
Toxicological Risk Assessment (ISO 10993-17):
ISO 10993-17 outlines the process of assessing the toxicological risks associated with medical devices. This assessment involves analyzing the potential harmful effects of the materials and substances used in the device on biological systems. It considers factors such as exposure pathways, dosage, and the body's responses. The goal is to determine whether the device's materials are safe for the intended use and to establish appropriate exposure limits.
Together, these tests and assessments play a critical role in ensuring the safety and biocompatibility of medical devices. By adhering to ISO 10993-18 and ISO 10993-17, manufacturers demonstrate their commitment to producing devices that are free from harmful chemicals and materials, ultimately safeguarding patient health and well-being.
In summary, Chemical Characterisation Test (ISO 10993-18) evaluates a medical device's chemical composition, while Toxicological Risk Assessment (ISO 10993-17) assesses potential risks associated with device materials. These processes contribute to producing safe and biocompatible medical devices that prioritize patient safety and regulatory compliance.
We provide technical support to assist Chemical characterisation tests and TRA for compliance with ISO 10993-18 and ISO 10993-17.
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