Overview
SIST EN ISO 10993-17:2024/A1:2026 is the Slovenian adoption of Amendment 1 to the internationally recognized standard for medical device safety: ISO 10993-17, Part 17 - Toxicological risk assessment of medical device constituents. This standard, prepared by ISO Technical Committee 194 and CEN/TC 206, ensures consistent, harmonized approaches for assessing potential toxicological risks posed by materials and chemicals in medical devices. The amendment brings technical and editorial updates reflecting latest scientific knowledge and regulatory needs.
Biological evaluation of medical devices is central to device safety and compliance with regulatory frameworks, such as the European Regulation (EU) 2017/745 on medical devices. This standard is a critical reference for manufacturers, laboratories, and regulatory professionals involved in toxicological risk assessment and conformity with EU General Safety and Performance Requirements (GSPRs).
Key Topics
SIST EN ISO 10993-17:2024/A1:2026 focuses on:
- Toxicological Risk Assessment Process: Outlines systematic evaluation of chemicals in or on medical devices, assessing their potential for harm when used as intended.
- Identification of Hazardous Substances: Includes methodologies for identifying constituents, including those that may be carcinogenic, mutagenic, toxic to reproduction, or endocrine disruptors.
- Exposure Assessment: Provides requirements for determining how much of each chemical will contact the body, factoring in the duration and frequency of exposure.
- Use of Thresholds and Mathematical Models: Recommends applying toxicological screening limits (TSL), thresholds of toxicological concern (TTC), and relevant mathematical models for exposure estimation.
- Documentation and Record-Keeping: Emphasizes thorough reporting to support clinical evaluation, post-market surveillance, and regulatory compliance.
- Alignment with Regulatory Requirements: The amendment highlights harmonization with Regulation (EU) 2017/745, ensuring processes meet the General Safety and Performance Requirements.
Applications
SIST EN ISO 10993-17:2024/A1:2026 is practical and vital for organizations involved in the design, development, testing, and regulatory submission of medical devices. Key applications include:
- Medical Device Manufacturers: Ensuring that materials and processing aids used in medical devices do not pose unacceptable toxicological risk to patients or users.
- Regulatory Compliance: Demonstrating conformity with European MDR (EU 2017/745) requirements, particularly regarding the biological safety and toxicological profiles of device constituents.
- Risk Management Systems: Integrating toxicological risk evaluation within ISO 14971-based risk management systems for medical device lifecycle assurance.
- Clinical Safety: Supporting clinical evaluation by providing scientific justification for the absence or acceptability of toxicological risk from device constituents.
- Quality Assurance: Meeting the expectations of quality management and post-market surveillance processes mandated by regulatory authorities.
Related Standards
This amendment is part of a larger set of standards and closely references:
- ISO 10993-1:2018 / EN ISO 10993-1:2020: Biological evaluation of medical devices - Evaluation and testing within a risk management process.
- ISO 10993-18:2020 / EN ISO 10993-18:2020: Chemical characterization of medical device materials within a risk management process.
- ISO 14971:2019 / EN ISO 14971:2019: Application of risk management to medical devices.
- ISO/TS 21726:2019: Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC).
Implementing SIST EN ISO 10993-17:2024/A1:2026 supports compliance and market access within the European Union and internationally, fostering patient safety and device effectiveness through robust toxicological risk assessment of medical device constituents.
