BS EN ISO 10993-17:2023+A1:2025 - Biological Evaluation of Medical Devices

The BS EN ISO 10993-17:2023+A1:2025 is an essential standard for professionals in the medical device industry, focusing on the toxicological risk assessment of medical device constituents. This comprehensive document provides a framework for evaluating the biological safety of medical devices, ensuring they meet the highest standards of patient safety and regulatory compliance.

Key Features of the Standard

• Standard Number: BS EN ISO 10993-17:2023+A1:2025
• Pages: 82
• Release Date: January 7, 2026
• ISBN: 978 0 539 29311 1
• Status: Standard

Comprehensive Toxicological Risk Assessment

This standard is a critical tool for conducting a thorough toxicological risk assessment of medical device constituents. It provides detailed guidance on identifying potential toxicological hazards and evaluating the risks associated with exposure to various materials used in medical devices. By following the guidelines set forth in this standard, manufacturers can ensure that their products are safe for use and comply with international regulatory requirements.

Why Choose BS EN ISO 10993-17:2023+A1:2025?

Choosing this standard means committing to the highest level of safety and quality in medical device manufacturing. It is designed to help manufacturers:

• Identify and assess potential toxicological risks associated with device materials.
• Ensure compliance with international safety regulations and standards.
• Enhance the safety profile of medical devices, thereby increasing patient trust and satisfaction.
• Streamline the product development process by providing clear guidelines and methodologies.

Who Should Use This Standard?

The BS EN ISO 10993-17:2023+A1:2025 is indispensable for a wide range of professionals in the medical device industry, including:

• Regulatory Affairs Specialists
• Quality Assurance Managers
• Product Development Engineers
• Biomedical Researchers
• Compliance Officers

Enhancing Patient Safety

Patient safety is the cornerstone of medical device development, and this standard plays a pivotal role in safeguarding it. By providing a structured approach to toxicological risk assessment, it helps manufacturers identify and mitigate potential risks before they can impact patient health. This proactive approach not only protects patients but also enhances the reputation of manufacturers committed to delivering safe and effective medical devices.

Global Relevance and Compliance

As a globally recognized standard, BS EN ISO 10993-17:2023+A1:2025 ensures that medical devices meet international safety and quality benchmarks. Compliance with this standard is often a prerequisite for entering global markets, making it an essential component of any international regulatory strategy. By adhering to this standard, manufacturers can confidently expand their market reach and ensure their products are accepted worldwide.

Conclusion

The BS EN ISO 10993-17:2023+A1:2025 is more than just a standard; it is a commitment to excellence in the medical device industry. By providing a robust framework for toxicological risk assessment, it empowers manufacturers to create safer, more reliable products that meet the needs of patients and healthcare providers alike. Invest in this standard to ensure your medical devices are at the forefront of safety and innovation.

BS EN ISO 10993-17:2023+A1:2025

This standard BS EN ISO 10993-17:2023+A1:2025 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices