BS EN ISO 5840-3:2021 Cardiovascular Implants: Cardiac Valve Prostheses

Welcome to the world of advanced cardiovascular solutions with the BS EN ISO 5840-3:2021 standard. This comprehensive document is an essential resource for professionals involved in the design, testing, and implementation of cardiac valve prostheses, specifically those heart valve substitutes that are implanted using transcatheter techniques.

Overview

The BS EN ISO 5840-3:2021 standard is a pivotal document that provides detailed guidelines and specifications for cardiovascular implants, focusing on cardiac valve prostheses. Released on February 8, 2021, this standard is a testament to the latest advancements in medical technology and practices. It is a crucial tool for ensuring the safety, efficacy, and quality of heart valve substitutes that are implanted via transcatheter techniques.

Key Features

• Standard Number: BS EN ISO 5840-3:2021
• Pages: 66
• ISBN: 978 0 539 02794 5
• Status: Standard

Why Choose BS EN ISO 5840-3:2021?

This standard is indispensable for professionals in the field of cardiovascular medicine and medical device manufacturing. Here are some reasons why this document is a must-have:

• Comprehensive Guidelines: The standard provides exhaustive guidelines that cover all aspects of cardiac valve prostheses, from design and testing to clinical evaluation and post-market surveillance.
• Focus on Transcatheter Techniques: With the growing popularity of minimally invasive procedures, this standard specifically addresses heart valve substitutes implanted by transcatheter techniques, ensuring that practitioners have the most relevant and up-to-date information.
• International Recognition: As part of the ISO standards, this document is recognized globally, making it a valuable resource for international collaborations and compliance.
• Quality Assurance: Adhering to this standard ensures that the cardiac valve prostheses meet the highest quality and safety standards, providing peace of mind to both healthcare providers and patients.

Applications

The BS EN ISO 5840-3:2021 standard is applicable to a wide range of stakeholders in the cardiovascular field, including:

• Medical Device Manufacturers: Ensures that products meet international safety and performance standards.
• Healthcare Providers: Provides guidelines for the safe and effective use of cardiac valve prostheses.
• Regulatory Bodies: Offers a benchmark for evaluating the compliance of cardiovascular implants.
• Research Institutions: Serves as a foundation for further research and development in the field of cardiovascular implants.

Content Highlights

The document spans 66 pages and is meticulously structured to cover various critical aspects of cardiac valve prostheses. Some of the key sections include:

• Design and Manufacturing: Detailed specifications for the design and manufacturing processes to ensure the highest quality of heart valve substitutes.
• Testing and Evaluation: Comprehensive testing protocols to assess the performance and safety of the implants.
• Clinical Considerations: Guidelines for clinical evaluation and the implementation of best practices in patient care.
• Post-Market Surveillance: Strategies for monitoring the performance of the implants after they have been introduced to the market.

Conclusion

The BS EN ISO 5840-3:2021 standard is an invaluable resource for anyone involved in the field of cardiovascular implants. Its comprehensive guidelines and international recognition make it a cornerstone document for ensuring the safety, efficacy, and quality of cardiac valve prostheses. By adhering to this standard, professionals can contribute to the advancement of cardiovascular medicine and improve patient outcomes worldwide.

Embrace the future of cardiovascular care with the BS EN ISO 5840-3:2021 standard, and ensure that your practices and products are aligned with the latest advancements in medical technology.

BS EN ISO 5840-3:2021

This standard BS EN ISO 5840-3:2021 Cardiovascular implants. Cardiac valve prostheses is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.

This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).