BS EN ISO 14708-6:2022 - Implants for Surgery: Active Implantable Medical Devices

Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia (Including Implantable Defibrillators)

Standard Number: BS EN ISO 14708-6:2022

Pages: 76

Released: 2022-08-03

ISBN: 978 0 580 94685 1

Status: Standard

Overview

The BS EN ISO 14708-6:2022 standard is a comprehensive guideline for the design, testing, and implementation of active implantable medical devices specifically intended to treat tachyarrhythmia, including implantable defibrillators. This standard is essential for manufacturers, healthcare providers, and regulatory bodies to ensure the safety, efficacy, and reliability of these life-saving devices.

Key Features

• Comprehensive Coverage: Spanning 76 pages, this standard provides detailed requirements and guidelines for the entire lifecycle of active implantable medical devices, from design and development to clinical evaluation and post-market surveillance.
• Latest Release: Published on August 3, 2022, this standard incorporates the latest advancements and best practices in the field of medical implants.
• International Recognition: As an ISO standard, it is recognized and adopted globally, ensuring consistency and harmonization across different regions and markets.
• Specific Focus: Tailored specifically for devices intended to treat tachyarrhythmia, including implantable defibrillators, ensuring that the unique challenges and requirements of these devices are thoroughly addressed.

Why This Standard is Important

Tachyarrhythmia, a condition characterized by an abnormally fast heart rate, can be life-threatening if not properly managed. Implantable defibrillators are critical in detecting and correcting these irregular heartbeats, thereby preventing sudden cardiac arrest. The BS EN ISO 14708-6:2022 standard ensures that these devices meet stringent safety and performance criteria, providing peace of mind to both patients and healthcare providers.

Detailed Requirements

This standard outlines specific requirements for various aspects of active implantable medical devices, including:

• Design and Construction: Guidelines on the materials, components, and overall design to ensure durability and biocompatibility.
• Performance Testing: Rigorous testing protocols to validate the device's functionality, reliability, and safety under different conditions.
• Clinical Evaluation: Requirements for clinical trials and studies to assess the device's effectiveness and identify any potential risks.
• Labeling and Documentation: Clear instructions and information for both healthcare providers and patients to ensure proper use and maintenance of the device.
• Post-Market Surveillance: Ongoing monitoring and reporting requirements to track the device's performance and address any issues that may arise after it has been implanted.

Who Should Use This Standard?

The BS EN ISO 14708-6:2022 standard is an invaluable resource for a wide range of stakeholders, including:

• Manufacturers: To ensure their products meet the highest standards of safety and performance.
• Healthcare Providers: To understand the capabilities and limitations of the devices they are implanting and managing.
• Regulatory Bodies: To establish and enforce regulations that protect patient safety and promote innovation in medical technology.
• Researchers: To guide the development of new and improved devices for treating tachyarrhythmia.

Conclusion

The BS EN ISO 14708-6:2022 standard is a critical document for anyone involved in the development, regulation, or use of active implantable medical devices intended to treat tachyarrhythmia. By adhering to the guidelines and requirements set forth in this standard, stakeholders can ensure that these life-saving devices are safe, effective, and reliable, ultimately improving patient outcomes and quality of life.

BS EN ISO 14708-6:2022

This standard BS EN ISO 14708-6:2022 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 that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply. Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2. NOTE 1 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 some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.