BS EN ISO 5840-2:2021 Cardiovascular Implants: Cardiac Valve Prostheses

Introducing the BS EN ISO 5840-2:2021, a comprehensive standard that sets the benchmark for cardiovascular implants, specifically focusing on surgically implanted heart valve substitutes. This standard is an essential resource for professionals in the medical device industry, healthcare providers, and researchers dedicated to advancing cardiac care.

Overview

The BS EN ISO 5840-2:2021 standard provides detailed guidelines and specifications for the design, testing, and evaluation of cardiac valve prostheses. These prostheses are critical components in the treatment of heart valve diseases, offering life-saving solutions for patients requiring valve replacement surgery.

Key Features

• Standard Number: BS EN ISO 5840-2:2021
• Pages: 60
• Released: February 8, 2021
• ISBN: 978 0 539 02791 4
• Status: Standard

Importance of the Standard

This standard is crucial for ensuring the safety, efficacy, and quality of cardiac valve prostheses. It provides a framework for manufacturers to develop products that meet rigorous international standards, thereby enhancing patient outcomes and reducing the risk of complications associated with heart valve surgeries.

Comprehensive Guidelines

The BS EN ISO 5840-2:2021 encompasses a wide range of topics, including:

• Design and material specifications for cardiac valve prostheses
• Preclinical testing requirements to assess durability and performance
• Clinical evaluation protocols to ensure safety and effectiveness
• Post-market surveillance to monitor long-term outcomes

Who Should Use This Standard?

This standard is indispensable for:

• Medical Device Manufacturers: Ensuring that products meet international quality and safety standards.
• Healthcare Providers: Understanding the specifications and performance criteria of cardiac valve prostheses to make informed decisions for patient care.
• Regulatory Bodies: Establishing guidelines for the approval and monitoring of cardiovascular implants.
• Researchers: Advancing the development of innovative heart valve technologies.

Advancing Cardiac Care

The BS EN ISO 5840-2:2021 plays a pivotal role in advancing cardiac care by setting high standards for the development and evaluation of heart valve prostheses. By adhering to these guidelines, manufacturers can ensure that their products provide reliable and effective solutions for patients with heart valve disorders.

Commitment to Quality and Safety

With a focus on quality and safety, this standard helps to minimize the risks associated with heart valve surgeries. It ensures that cardiac valve prostheses are designed and tested to withstand the physiological demands of the human body, providing patients with durable and effective treatment options.

Conclusion

The BS EN ISO 5840-2:2021 is an essential standard for anyone involved in the development, regulation, or use of cardiac valve prostheses. By providing comprehensive guidelines and specifications, it supports the creation of high-quality, safe, and effective heart valve substitutes that improve patient outcomes and advance the field of cardiovascular medicine.

For those committed to excellence in cardiac care, the BS EN ISO 5840-2:2021 is an invaluable resource that ensures the highest standards are met in the design and implementation of heart valve prostheses.

BS EN ISO 5840-2:2021

This standard BS EN ISO 5840-2:2021 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 heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.

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

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

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

For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.