BS EN ISO 10993-17:2009

Overview

BS EN ISO 10993-17:2009 provides a framework for the biological evaluation of medical devices, specifically focusing on the establishment of allowable limits for leachable substances. This standard is essential for manufacturers and regulatory bodies to ensure that medical devices are safe for human use and do not pose a risk due to harmful substances that may leach from the device into the body.

Key Requirements

The standard outlines several key requirements that must be adhered to during the evaluation process:

• Identification of Leachable Substances: Manufacturers must identify all potential leachable substances from the medical device, which may include chemicals used in the manufacturing process, packaging materials, or sterilisation agents.
• Risk Assessment: A comprehensive risk assessment must be conducted to evaluate the potential health risks associated with the identified leachable substances. This includes toxicological assessments and exposure evaluations.
• Establishment of Allowable Limits: The standard provides guidance on how to establish allowable limits for leachable substances based on their toxicological profiles and potential exposure scenarios.
• Testing Protocols: Manufacturers are required to implement appropriate testing protocols to quantify the levels of leachable substances in their medical devices.

Implementation Benefits

Adopting BS EN ISO 10993-17:2009 can offer numerous benefits to manufacturers and stakeholders in the healthcare sector:

• Enhanced Safety: By identifying and controlling leachable substances, manufacturers can significantly reduce the risk of adverse health effects associated with medical devices.
• Regulatory Compliance: Compliance with this standard facilitates adherence to regulatory requirements, thus streamlining the approval process for medical devices.
• Market Confidence: Demonstrating compliance with BS EN ISO 10993-17:2009 can enhance market confidence in the safety and efficacy of medical devices, fostering trust among healthcare providers and patients.
• Improved Product Quality: The rigorous evaluation process encourages manufacturers to improve their product quality and safety profiles, leading to better patient outcomes.

Compliance Value

Compliance with BS EN ISO 10993-17:2009 is critical for manufacturers aiming to market their medical devices in Europe and beyond. Regulatory bodies often require evidence of biological safety, and adherence to this standard provides a clear pathway to demonstrate compliance. Furthermore, it aligns with the broader ISO 10993 series, which addresses various aspects of biological evaluation, ensuring a comprehensive approach to safety assessment.

In conclusion, BS EN ISO 10993-17:2009 serves as a vital resource for manufacturers of medical devices, guiding them through the complex landscape of biological evaluation and leachable substances. By following its guidelines, manufacturers can ensure the safety of their products, comply with regulatory requirements, and ultimately contribute to better health outcomes for patients.