BS EN ISO 14708-5:2022 - Implants for Surgery. Active Implantable Medical Devices Circulatory Support Devices

Introducing the BS EN ISO 14708-5:2022, the definitive standard for active implantable medical devices specifically designed for circulatory support. This comprehensive document is essential for professionals in the medical field, providing detailed guidelines and specifications to ensure the highest quality and safety of circulatory support devices.

Key Features and Benefits

The BS EN ISO 14708-5:2022 standard is meticulously crafted to cover all aspects of circulatory support devices, from design and manufacturing to testing and clinical evaluation. Here are some of the key features and benefits:

• Comprehensive Coverage: Spanning 80 pages, this standard provides in-depth information and guidelines to ensure the optimal performance and safety of circulatory support devices.
• Up-to-Date Information: Released on August 3, 2022, this standard reflects the latest advancements and best practices in the field of active implantable medical devices.
• Global Recognition: As an ISO standard, it is recognized and respected worldwide, ensuring that your devices meet international quality and safety benchmarks.
• ISBN: 978 0 539 00246 1 - Easily reference and cite this standard in your documentation and research.

Why Choose BS EN ISO 14708-5:2022?

Choosing the BS EN ISO 14708-5:2022 standard means committing to excellence and safety in the development and implementation of circulatory support devices. Here’s why this standard is indispensable:

Ensuring Patient Safety

Patient safety is paramount in the medical field. This standard provides rigorous guidelines to ensure that circulatory support devices are safe for implantation and use. By adhering to these guidelines, manufacturers can minimize risks and enhance patient outcomes.

Enhancing Device Performance

Performance is critical for circulatory support devices. The BS EN ISO 14708-5:2022 standard outlines the necessary performance criteria and testing methods to ensure that devices function effectively and reliably under various conditions.

Facilitating Regulatory Compliance

Compliance with international standards is often a prerequisite for regulatory approval. The BS EN ISO 14708-5:2022 standard helps manufacturers meet regulatory requirements, facilitating smoother approval processes and market entry.

Supporting Innovation

Innovation is at the heart of medical advancements. This standard provides a framework that supports the development of new and improved circulatory support devices, encouraging innovation while maintaining high safety and performance standards.

Who Should Use This Standard?

The BS EN ISO 14708-5:2022 standard is designed for a wide range of professionals in the medical device industry, including:

• Medical Device Manufacturers
• Quality Assurance and Regulatory Affairs Professionals
• Biomedical Engineers
• Clinical Researchers
• Healthcare Providers

Detailed Specifications

Standard Number	BS EN ISO 14708-5:2022
Pages	80
Released	2022-08-03
ISBN	978 0 539 00246 1
Name	Implants for surgery. Active implantable medical devices Circulatory support devices
Status	Standard

Conclusion

The BS EN ISO 14708-5:2022 standard is an invaluable resource for anyone involved in the design, manufacture, and regulation of circulatory support devices. By adhering to this standard, you can ensure that your devices meet the highest standards of safety and performance, ultimately improving patient outcomes and advancing the field of medical technology.

Invest in the BS EN ISO 14708-5:2022 standard today and take a significant step towards excellence in the development and implementation of circulatory support devices.

BS EN ISO 14708-5:2022

This standard BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: — ventricular assist devices (VAD), left or right heart support; — total artificial hearts (TAH); — biventricular assist devices (biVAD); — percutaneous assist devices; — paediatric assist devices.