BS ISO 14243-2:2016 - Overview

The BS ISO 14243-2:2016, published on September 30, 2016, is an essential standard for healthcare technology that outlines critical performance requirements for artificial hip joints. Utilizing a robust framework established by the International Organization for Standardization, this standard ensures the safety, effectiveness, and longevity of hip implant devices that are integral to modern orthopedic practices.

Purpose and Importance

The purpose of BS ISO 14243-2:2016 is to define a methodology for testing and measuring the wear of acetabular surfaces in total hip prostheses. This standard is pivotal for manufacturers, healthcare providers, and regulatory bodies as it provides precise guidelines for evaluating the tribological performance of materials used in hip implants. By ensuring that these devices meet strict wear resistance criteria, the standard helps mitigate failure rates and enhance patient outcomes.

Key Specifications

This standard entails comprehensive testing protocols, setting forth the parameters for both laboratory and clinical conditions, thereby ensuring consistent results across different testing environments. It also addresses factors such as:

• Material Selection: Guidelines on suitable materials for hip joint components, particularly focusing on wear resistance and biocompatibility.
• Testing Environment: Specifications for simulating physiological conditions during wear testing to ensure realistic evaluations of implant performance.
• Reporting Requirements: Standardized documentation for test results to facilitate comparability across various studies and evaluations.
• Durability Assessment: Techniques for assessing long-term performance under simulated use conditions.

Who Should Use This Standard?

BS ISO 14243-2:2016 is primarily designed for manufacturers of hip prostheses, engineers, researchers in medical technology, and regulatory agencies concerned with the development and approval of orthopedic devices. By adhering to this standard, these stakeholders can ensure that hip implants not only meet regulatory demands but also provide optimal performance and safety for patients.

Conclusion

Investing in BS ISO 14243-2:2016 is crucial for any entity involved in the design, manufacture, or regulation of hip joint implants. Priced at £188.00, this comprehensive standard is an invaluable resource that supports the advancement of orthopedic technology, striving toward enhanced patient care and improved quality of life.