BS ISO 14117:2019 - Active Implantable Medical Devices

Discover the essential standard for ensuring the electromagnetic compatibility of life-saving medical devices with the BS ISO 14117:2019. This comprehensive document is a must-have for professionals in the medical device industry, providing detailed EMC test protocols specifically designed for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.

Overview

The BS ISO 14117:2019 standard is a critical resource for manufacturers, engineers, and healthcare professionals involved in the development and deployment of active implantable medical devices. Released on September 4, 2019, this standard ensures that these devices operate safely and effectively in environments where electromagnetic interference (EMI) is a concern.

Key Features

• Standard Number: BS ISO 14117:2019
• Pages: 146
• Released: 2019-09-04
• ISBN: 978 0 580 99091 5
• Status: Standard

Why Electromagnetic Compatibility Matters

Electromagnetic compatibility (EMC) is crucial for the safe operation of medical devices, particularly those implanted in the human body. These devices must function reliably without interference from other electronic equipment, which can be a common occurrence in medical settings. The BS ISO 14117:2019 standard provides the necessary protocols to test and ensure that these devices can withstand and operate effectively in the presence of electromagnetic fields.

Comprehensive EMC Test Protocols

This standard outlines a series of rigorous test protocols that are essential for assessing the electromagnetic compatibility of implantable cardiac devices. These protocols are designed to simulate real-world conditions and ensure that devices can maintain their performance and safety standards in various electromagnetic environments. By adhering to these protocols, manufacturers can guarantee that their products meet the highest safety and performance standards.

Who Should Use This Standard?

The BS ISO 14117:2019 is indispensable for:

• Medical Device Manufacturers: Ensure your products meet international safety and performance standards.
• Biomedical Engineers: Design and test devices with confidence, knowing they will perform reliably in the field.
• Healthcare Providers: Gain assurance that the devices used in patient care are safe and effective.
• Regulatory Bodies: Use this standard as a benchmark for evaluating the compliance of medical devices.

Benefits of Compliance

Compliance with the BS ISO 14117:2019 standard offers numerous benefits, including:

• Enhanced Safety: Protect patients by ensuring devices are immune to electromagnetic interference.
• Improved Reliability: Devices that meet EMC standards are more likely to perform consistently and accurately.
• Regulatory Approval: Facilitate the approval process by demonstrating compliance with international standards.
• Market Access: Gain access to global markets by adhering to widely recognized standards.

Conclusion

The BS ISO 14117:2019 standard is an invaluable tool for anyone involved in the design, manufacture, or regulation of active implantable medical devices. By providing detailed EMC test protocols, this standard ensures that these critical devices can operate safely and effectively in a variety of electromagnetic environments. Whether you are a manufacturer, engineer, healthcare provider, or regulatory body, this standard is essential for ensuring the safety and reliability of implantable cardiac devices.

Invest in the BS ISO 14117:2019 standard today and ensure that your medical devices meet the highest standards of electromagnetic compatibility and patient safety.

BS ISO 14117:2019

This standard BS ISO 14117:2019 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics
• 33.100.01 Electromagnetic compatibility in general

1

This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems.

NOTE

This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:

• —

  0 Hz ?  ƒ < 385 MHz;

• —

  385 MHz ?  ƒ ? 3 000 MHz

This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.