BS ISO 19213:2017

Overview

BS ISO 19213:2017 specifies the test methods for materials intended for use as a cortical bone model in surgical implants. This standard is essential for ensuring that materials used in medical implants mimic the properties of human cortical bone, thereby enhancing the safety and effectiveness of surgical procedures. The standard outlines rigorous testing protocols that assess the mechanical and physical properties of these materials, ensuring they meet the necessary requirements for clinical applications.

Key Requirements

The standard provides detailed methodologies for evaluating various characteristics of materials used in cortical bone models. Key requirements include:

• Mechanical Testing: Assessment of tensile strength, compressive strength, and elasticity to ensure the material can withstand physiological loads.
• Physical Properties: Evaluation of density, porosity, and surface characteristics to replicate the natural bone environment.
• Biocompatibility: Testing to confirm that the materials do not elicit adverse biological responses when implanted.
• Durability: Long-term performance assessments to ensure materials maintain their integrity over time under physiological conditions.

Implementation Benefits

Adhering to BS ISO 19213:2017 provides numerous benefits for manufacturers and healthcare providers:

• Enhanced Safety: By ensuring that materials closely mimic the properties of natural bone, the risk of implant failure is significantly reduced.
• Improved Patient Outcomes: High-quality materials contribute to better integration with the host bone, leading to faster recovery and improved functionality.
• Regulatory Compliance: Compliance with this standard facilitates meeting the requirements set forth by regulatory bodies, streamlining the approval process for new implants.
• Market Competitiveness: Adopting established standards can enhance a manufacturer's reputation and credibility in the healthcare market.

Compliance Value

Compliance with BS ISO 19213:2017 is crucial for any organisation involved in the development and production of surgical implants. This standard not only helps in achieving regulatory approval but also fosters trust among healthcare professionals and patients. By implementing the testing protocols outlined in the standard, manufacturers can ensure that their products are safe, effective, and reliable.

In summary, BS ISO 19213:2017 serves as a vital framework for the evaluation of materials used in cortical bone models. Its rigorous testing methods help ensure that surgical implants meet the highest standards of safety and performance, ultimately benefiting patient care and advancing healthcare technology.