BS ISO 22679:2021 Cardiovascular Implants. Transcatheter Cardiac Occluders

Standard Number: BS ISO 22679:2021

Pages: 82

Released: 2021-12-01

ISBN: 978 0 580 51866 9

Name: Cardiovascular Implants. Transcatheter Cardiac Occluders

Status: Standard

Overview

The BS ISO 22679:2021 standard is a comprehensive guide dedicated to cardiovascular implants, specifically focusing on transcatheter cardiac occluders. Released on December 1, 2021, this standard is an essential resource for professionals in the medical device industry, healthcare providers, and regulatory bodies. With 82 pages of detailed information, it provides a thorough understanding of the requirements, testing, and performance criteria for these critical medical devices.

Key Features

• Comprehensive Coverage: The standard covers all aspects of transcatheter cardiac occluders, from design and manufacturing to testing and clinical evaluation.
• Up-to-Date Information: Released in December 2021, it includes the latest advancements and best practices in the field of cardiovascular implants.
• International Standard: As an ISO standard, it is recognized and respected globally, ensuring consistency and reliability in the quality of cardiac occluders.
• Detailed Guidelines: With 82 pages of content, it provides in-depth guidelines and specifications to ensure the safety and efficacy of transcatheter cardiac occluders.

Why Choose BS ISO 22679:2021?

The BS ISO 22679:2021 standard is an invaluable tool for anyone involved in the development, manufacturing, or regulation of cardiovascular implants. Here are some reasons why this standard is a must-have:

• Ensures Patient Safety: By adhering to the guidelines and requirements outlined in this standard, manufacturers can ensure that their products meet the highest safety standards, ultimately protecting patients.
• Facilitates Regulatory Compliance: Compliance with this ISO standard helps manufacturers meet regulatory requirements in various countries, simplifying the approval process for new devices.
• Promotes Innovation: The standard encourages innovation by providing a clear framework for the development of new and improved transcatheter cardiac occluders.
• Enhances Quality Control: Detailed testing and performance criteria help manufacturers maintain consistent quality in their products, reducing the risk of defects and recalls.

Who Should Use This Standard?

The BS ISO 22679:2021 standard is designed for a wide range of professionals and organizations, including:

• Medical Device Manufacturers: Companies involved in the design and production of cardiovascular implants will find this standard essential for ensuring their products meet international quality and safety standards.
• Healthcare Providers: Hospitals, clinics, and healthcare professionals can use this standard to evaluate the quality and safety of the transcatheter cardiac occluders they use in patient care.
• Regulatory Bodies: Government agencies and regulatory organizations can use this standard as a benchmark for evaluating and approving new cardiovascular implants.
• Research Institutions: Academic and research institutions involved in the study of cardiovascular implants can use this standard as a reference for their work.

Detailed Content

The BS ISO 22679:2021 standard is divided into several sections, each providing detailed information on different aspects of transcatheter cardiac occluders. Some of the key sections include:

• Design and Manufacturing: Guidelines on the design and manufacturing processes to ensure the safety and efficacy of the devices.
• Materials and Biocompatibility: Specifications for the materials used in the devices and their biocompatibility with human tissue.
• Testing and Performance: Detailed testing procedures and performance criteria to ensure the devices function as intended.
• Clinical Evaluation: Guidelines for the clinical evaluation of the devices, including clinical trials and post-market surveillance.
• Labeling and Documentation: Requirements for labeling and documentation to ensure clear communication of the device's intended use, risks, and benefits.

Conclusion

The BS ISO 22679:2021 standard is an essential resource for anyone involved in the field of cardiovascular implants. With its comprehensive coverage, up-to-date information, and detailed guidelines, it provides a solid foundation for the development, manufacturing, and regulation of transcatheter cardiac occluders. By adhering to this standard, manufacturers can ensure the safety and efficacy of their products, ultimately improving patient outcomes and advancing the field of cardiovascular medicine.

BS ISO 22679:2021

This standard BS ISO 22679:2021 Cardiovascular implants. Transcatheter cardiac occluders is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics