What is EN ISO 10993-182021?

The field of medical device manufacturing and regulation is constantly evolving to ensure product safety for patients. One such standard that has garnered significant attention is EN ISO 10993-18:2021, which provides guidelines for the chemical characterization of medical devices.

Rationale and Scope

EN ISO 10993-18:2021 focuses on the evaluation of potentially harmful chemicals that can be released from a medical device and their potential impact on patient health. It aims to assess the biocompatibility of medical devices by investigating potential toxicological hazards associated with chemical substances present in these devices.

Key Requirements and Testing Methods

The standard mandates that manufacturers conduct an in-depth chemical characterization of their medical devices, covering both the materials used and any possible degradation products. This involves conducting a risk assessment to identify potentially hazardous chemical substances and selecting appropriate testing methods to assess their biological effects. The standard outlines various analytical techniques, such as gas chromatography and mass spectrometry, to determine the presence and levels of chemicals released from the device.

Additionally, the standard provides guidance on assessing the toxicological profile of identified substances and establishing acceptable exposure limits. This includes determining the mode of exposure (e.g., inhalation, ingestion, or contact) and evaluating toxicological endpoints, such as acute toxicity, genotoxicity, and carcinogenicity. The standard further emphasizes the importance of considering cumulative exposures to chemicals that may result from the use of multiple medical devices.

Application and Implications

Adherence to EN ISO 10993-18:2021 is crucial for medical device manufacturers to meet regulatory requirements and demonstrate the safety and efficacy of their products. Compliance with this standard helps ensure that potential risks associated with chemical substances released from medical devices are minimized and mitigated, ultimately safeguarding patient health.

For regulatory bodies, EN ISO 10993-18:2021 provides a benchmark for evaluating the biocompatibility of medical devices and setting guidelines for market approval. It enables them to establish comprehensive regulatory frameworks that address the potential risks posed by chemical substances in medical devices.