BS ISO 19233-1:2017

Overview

BS ISO 19233-1:2017 specifies a procedure for producing parametric 3D bone models from computed tomography (CT) data of the knee. This standard is crucial for the development and manufacturing of orthopaedic joint prostheses, ensuring that surgical implants are tailored to the anatomical requirements of individual patients.

Key Requirements

• Data Acquisition: The standard outlines the necessary protocols for acquiring CT data, including imaging parameters and patient positioning.
• Model Generation: It details the processes for converting CT data into parametric 3D models, including software requirements and validation methods.
• Accuracy and Precision: BS ISO 19233-1:2017 establishes criteria for the accuracy and precision of the generated models to ensure they meet clinical needs.
• Documentation: Comprehensive documentation practices are mandated to support traceability and reproducibility of the modelling process.

Implementation Benefits

Implementing BS ISO 19233-1:2017 provides numerous benefits for healthcare professionals and manufacturers:

• Enhanced Patient Outcomes: By utilising patient-specific 3D models, surgeons can plan and execute procedures with greater precision, leading to improved surgical outcomes.
• Streamlined Production: The standard facilitates a more efficient workflow in the production of orthopaedic implants, reducing lead times and costs.
• Innovation in Design: The parametric modelling approach allows for greater flexibility in implant design, accommodating a wider range of anatomical variations.

Compliance Value

Adhering to BS ISO 19233-1:2017 is essential for compliance with regulatory requirements in the healthcare sector. Compliance with this standard ensures that:

• Regulatory Approval: Manufacturers can demonstrate that their processes for creating 3D models meet international standards, facilitating smoother regulatory approvals.
• Quality Assurance: The standard promotes consistent quality in the production of orthopaedic implants, reducing the risk of complications associated with poorly fitted devices.
• Market Competitiveness: Companies that comply with BS ISO 19233-1:2017 can differentiate themselves in the marketplace by showcasing their commitment to quality and innovation.

In conclusion, BS ISO 19233-1:2017 is a pivotal standard for the healthcare technology sector, particularly in the field of orthopaedics. By following its guidelines, manufacturers and healthcare providers can enhance patient care, ensure regulatory compliance, and foster innovation in implant design.