BS ISO 7206-13:2016+A1:2022 - Implants for Surgery

Partial and Total Hip Joint Prostheses: Determination of Resistance to Torque of Head Fixation of Stemmed Femoral Components

Standard Number: BS ISO 7206-13:2016+A1:2022

Pages: 16

Released: 2022-06-17

ISBN: 978 0 539 19463 0

Status: Standard

Overview

The BS ISO 7206-13:2016+A1:2022 standard is an essential document for professionals in the field of orthopedic surgery and medical device manufacturing. This standard provides comprehensive guidelines for the determination of resistance to torque of head fixation of stemmed femoral components in partial and total hip joint prostheses. Ensuring the reliability and durability of hip joint prostheses is crucial for patient safety and long-term success of surgical implants.

Key Features

• Comprehensive Guidelines: This standard offers detailed procedures and methodologies for testing the resistance to torque of head fixation in femoral components, ensuring that the prostheses meet the highest standards of quality and safety.
• Updated Information: The 2022 amendment (A1:2022) includes the latest advancements and updates in the field, making sure that the standard remains relevant and up-to-date with current technologies and practices.
• International Recognition: As an ISO standard, it is recognized and respected globally, making it a valuable resource for international manufacturers and healthcare providers.
• Patient Safety: By adhering to this standard, manufacturers can ensure that their products provide reliable performance, reducing the risk of complications and improving patient outcomes.

Detailed Content

The document spans 16 pages and covers various aspects of the testing procedures, including:

• Scope and Field of Application: Defines the range of femoral components and head fixation methods covered by the standard.
• Test Apparatus and Materials: Specifies the equipment and materials required for conducting the tests.
• Test Procedures: Provides step-by-step instructions for performing the torque resistance tests, ensuring consistency and accuracy in results.
• Data Analysis and Reporting: Guidelines for analyzing the test data and reporting the results in a standardized format.
• Quality Control: Recommendations for quality control measures to ensure the reliability of the test results.

Importance for Manufacturers and Healthcare Providers

For manufacturers, adhering to the BS ISO 7206-13:2016+A1:2022 standard is crucial for gaining market approval and ensuring that their products meet the stringent requirements of regulatory bodies. It also helps in building trust with healthcare providers and patients by demonstrating a commitment to quality and safety.

Healthcare providers, on the other hand, can rely on this standard to select high-quality hip joint prostheses for their patients. By choosing products that comply with this standard, they can minimize the risk of implant failure and improve the overall success rate of hip replacement surgeries.

Conclusion

The BS ISO 7206-13:2016+A1:2022 standard is an indispensable resource for anyone involved in the design, manufacturing, and application of hip joint prostheses. Its comprehensive guidelines ensure that femoral components are tested rigorously for resistance to torque, thereby enhancing the safety and effectiveness of hip replacement surgeries. With its international recognition and up-to-date information, this standard is a must-have for maintaining the highest standards of quality in orthopedic implants.

BS ISO 7206-13:2016+A1:2022

This standard BS ISO 7206-13:2016+A1:2022 Implants for surgery. Partial and total hip joint prostheses is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics