BS ISO 12891-2:2020 - Retrieval and Analysis of Surgical Implants

Standard Number: BS ISO 12891-2:2020

Pages: 34

Released: 2024-05-08

ISBN: 978 0 539 12108 7

Status: Standard

Overview

The BS ISO 12891-2:2020 is an essential standard for professionals involved in the field of surgical implants. This comprehensive document provides detailed guidelines and methodologies for the retrieval and analysis of surgical implants, ensuring that the processes are conducted with precision and accuracy. As a critical resource, it aids in the understanding and improvement of implant performance and patient outcomes.

Purpose and Importance

Surgical implants play a vital role in modern medicine, offering solutions for a variety of medical conditions. However, the performance and longevity of these implants are crucial for patient safety and satisfaction. The BS ISO 12891-2:2020 standard addresses the need for systematic retrieval and analysis of these implants, providing a framework that helps in identifying potential issues and areas for improvement.

By adhering to this standard, healthcare professionals and researchers can ensure that the data collected from retrieved implants is reliable and useful for further research and development. This, in turn, contributes to the advancement of implant technology and enhances the quality of care provided to patients.

Key Features

• Comprehensive Guidelines: The standard offers a detailed approach to the retrieval and analysis of surgical implants, covering various aspects such as handling, documentation, and evaluation.
• Internationally Recognized: As part of the ISO standards, it is recognized globally, making it a valuable resource for professionals across different countries and regions.
• Up-to-Date Information: Released in 2024, this standard reflects the latest advancements and best practices in the field of surgical implants.
• Enhances Patient Safety: By following the guidelines, healthcare providers can improve the safety and effectiveness of surgical implants, ultimately benefiting patients.

Who Should Use This Standard?

The BS ISO 12891-2:2020 is designed for a wide range of professionals involved in the healthcare and medical device industries. This includes:

• Surgeons and Clinicians: To ensure the implants they use meet the highest standards of safety and performance.
• Biomedical Engineers: For designing and developing new implant technologies based on reliable data.
• Quality Assurance Professionals: To maintain compliance with international standards and improve product quality.
• Researchers: For conducting studies and analyses that contribute to the advancement of medical science.

Benefits of Compliance

Adhering to the BS ISO 12891-2:2020 standard offers numerous benefits, including:

• Improved Implant Design: By analyzing retrieved implants, manufacturers can identify design flaws and make necessary improvements.
• Enhanced Patient Outcomes: Better implant performance leads to improved patient satisfaction and reduced risk of complications.
• Regulatory Compliance: Meeting international standards helps organizations comply with regulatory requirements, avoiding potential legal issues.
• Competitive Advantage: Companies that adhere to high standards are often viewed more favorably by customers and stakeholders.

Conclusion

The BS ISO 12891-2:2020 standard is an invaluable tool for anyone involved in the field of surgical implants. By providing a structured approach to the retrieval and analysis of these devices, it ensures that the highest levels of safety and performance are maintained. Whether you are a healthcare provider, engineer, or researcher, this standard will help you achieve excellence in your work and contribute to the ongoing improvement of medical technology.

BS ISO 12891-2:2020

This standard BS ISO 12891-2:2020 Retrieval and analysis of surgical implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies methods for the analysis of retrieved surgical implants.

This document describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.

This document can also be applied to other materials, e.g. animal tissue implants.