BS EN ISO 5840-1:2021 Cardiovascular Implants - Cardiac Valve Prostheses General Requirements

Introducing the BS EN ISO 5840-1:2021, a comprehensive standard that sets the benchmark for cardiovascular implants, specifically focusing on cardiac valve prostheses. This essential document provides the general requirements necessary for the design, testing, and evaluation of cardiac valve prostheses, ensuring safety, reliability, and performance in medical applications.

Key Features

• Standard Number: BS EN ISO 5840-1:2021
• Pages: 88
• Release Date: February 8, 2021
• ISBN: 978 0 539 02790 7
• Status: Standard

Overview

The BS EN ISO 5840-1:2021 standard is a pivotal document for professionals in the field of cardiovascular medicine and biomedical engineering. It provides a detailed framework for the development and assessment of cardiac valve prostheses, which are critical components in the treatment of heart valve diseases. This standard is designed to guide manufacturers, researchers, and healthcare providers in ensuring that these life-saving devices meet the highest quality and safety standards.

Comprehensive Coverage

Spanning 88 pages, this standard offers an in-depth exploration of the various aspects of cardiac valve prostheses. It covers a wide range of topics, including:

• Design and material specifications
• Performance requirements
• Testing methodologies
• Clinical evaluation procedures
• Risk management and safety considerations

Each section is meticulously crafted to provide clear and concise guidelines, ensuring that all stakeholders have a thorough understanding of the requirements and best practices in the field.

Why Choose BS EN ISO 5840-1:2021?

The BS EN ISO 5840-1:2021 standard is an invaluable resource for anyone involved in the development, testing, or use of cardiac valve prostheses. Here are some reasons why this standard is a must-have:

• Global Recognition: As an ISO standard, it is recognized and respected worldwide, providing a common language and framework for international collaboration.
• Up-to-Date Information: Released in 2021, it reflects the latest advancements and research in the field, ensuring that you have access to the most current information.
• Comprehensive Guidance: It offers detailed guidance on every aspect of cardiac valve prostheses, from design to clinical evaluation, making it a one-stop resource for all your needs.
• Enhanced Safety and Performance: By adhering to this standard, you can ensure that your products meet the highest safety and performance standards, ultimately improving patient outcomes.

Who Can Benefit?

The BS EN ISO 5840-1:2021 standard is designed for a wide range of professionals, including:

• Medical device manufacturers
• Biomedical engineers
• Clinical researchers
• Healthcare providers
• Regulatory bodies

Whether you are involved in the design, testing, or clinical application of cardiac valve prostheses, this standard provides the essential knowledge and guidelines needed to excel in your field.

Conclusion

In the rapidly evolving field of cardiovascular medicine, staying informed and compliant with the latest standards is crucial. The BS EN ISO 5840-1:2021 standard offers a comprehensive and authoritative resource for ensuring the quality, safety, and effectiveness of cardiac valve prostheses. By integrating this standard into your practices, you can contribute to the advancement of medical technology and the improvement of patient care worldwide.

BS EN ISO 5840-1:2021

This standard BS EN ISO 5840-1:2021 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 and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

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

ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a 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 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.

ISO 5840-1 defines operational conditions for heart valve substitutes.

ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.

ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.