SN EN ISO 10993-17:2023 is a standard published by the International Organization for Standardization (ISO) that provides guidelines for toxicological risk assessment of medical device constituents as part of their biological evaluation process. This essential framework aids manufacturers in ensuring the safety and biocompatibility of their products.

Purpose and objectives

The purpose of SN EN ISO 10993-17:2023 is to establish a systematic approach to assessing the toxicological risks associated with the materials used in medical devices. The standard aims to provide a clear methodology for evaluating potential hazards, identifying hazardous substances, and estimating exposure levels. By adhering to these guidelines, manufacturers can ensure that their devices meet safety requirements outlined in ISO 10993-1, thereby facilitating regulatory compliance and protecting patient health. Ultimately, the objective is to ensure that medical devices are safe for use, minimizing any adverse effects on patients and users.

Scope: who must comply

SN EN ISO 10993-17:2023 applies to manufacturers and developers of medical devices across a variety of sectors, including pharmaceuticals, biotechnology, and medical technology. This standard is particularly relevant for organizations involved in the design, production, and distribution of devices that have direct or indirect contact with the human body, such as implants, surgical instruments, and diagnostic tools. Compliance is essential not only for product approval in regulated markets, such as the European Union under EU Regulation 2017/745, but also for maintaining industry credibility and ensuring patient safety in the healthcare technology context.

How SN EN ISO 10993-17:2023 relates to other standards

SN EN ISO 10993-17:2023 is closely related to several other ISO standards that focus on biocompatibility and risk assessment:

• ISO 10993-1: This standard outlines the general principles for biological evaluation of medical devices, establishing the framework within which toxicological risk assessments should be conducted.
• ISO 10993-18: Provides guidelines on chemical characterization of medical device materials, which is integral to the risk assessment process outlined in SN EN ISO 10993-17.
• ISO/TS 21726: Offers guidance on the establishment of a toxicological risk assessment strategy for medical devices, complementing the methodologies in SN EN ISO 10993-17.

Revision history and current status

The current revision of SN EN ISO 10993-17 was published in 2023, reflecting the latest advancements in toxicological science and risk assessment methodologies. Recent changes include updated criteria for risk evaluation, enhanced guidelines for the identification of hazardous constituents, and refined exposure assessment techniques. These revisions ensure that the standard remains relevant and effective in addressing contemporary challenges in medical device safety and compliance.