BS ISO 27186:2020 - Active Implantable Medical Devices

Welcome to the comprehensive guide on the BS ISO 27186:2020 standard, a pivotal document for professionals in the field of medical device engineering, particularly those involved with implantable cardiac rhythm management devices. This standard is essential for ensuring the safety, reliability, and performance of these critical medical devices.

Overview of BS ISO 27186:2020

The BS ISO 27186:2020 standard provides detailed specifications for a four-pole connector system used in implantable cardiac rhythm management devices. These devices are crucial for patients with cardiac arrhythmias, as they help regulate heartbeats and ensure proper cardiac function. The standard outlines the dimensional and test requirements necessary to ensure the connectors' compatibility and performance.

Key Features and Benefits

• Standard Number: BS ISO 27186:2020
• Pages: 90
• Release Date: December 1, 2020
• ISBN: 978 0 539 05230 5
• Status: Standard

This standard is a must-have for manufacturers and engineers who are involved in the design and production of implantable cardiac devices. It ensures that the devices meet international safety and performance benchmarks, thereby enhancing patient safety and device efficacy.

Dimensional and Test Requirements

The BS ISO 27186:2020 standard meticulously details the dimensional and test requirements for the four-pole connector system. These requirements are crucial for ensuring that the connectors are compatible with various implantable cardiac devices and can withstand the physiological conditions within the human body.

By adhering to these specifications, manufacturers can ensure that their devices are not only safe but also reliable over the long term. This is particularly important in the medical field, where device failure can have serious consequences for patient health.

Why Choose BS ISO 27186:2020?

Choosing the BS ISO 27186:2020 standard means choosing a commitment to quality and safety. This standard is recognized globally, making it an essential document for any company looking to market their implantable cardiac devices internationally. It provides a framework for ensuring that devices are manufactured to the highest standards, reducing the risk of device failure and improving patient outcomes.

Comprehensive Coverage

With 90 pages of detailed information, the BS ISO 27186:2020 standard offers comprehensive coverage of all aspects related to the four-pole connector system. From design specifications to testing protocols, this document serves as a complete guide for ensuring that your devices meet the necessary requirements.

Whether you are a seasoned professional or new to the field, this standard provides the guidance needed to navigate the complexities of implantable cardiac device manufacturing.

Global Recognition

The BS ISO 27186:2020 standard is recognized by regulatory bodies and industry professionals worldwide. By adhering to this standard, you demonstrate a commitment to quality and safety that is acknowledged across the globe. This can enhance your company's reputation and open up new markets for your products.

Conclusion

In conclusion, the BS ISO 27186:2020 standard is an indispensable resource for anyone involved in the design, production, or regulation of implantable cardiac rhythm management devices. Its detailed specifications and global recognition make it a cornerstone of quality assurance in the medical device industry.

Investing in this standard is an investment in the safety and efficacy of your products, ensuring that they meet the highest international standards and provide the best possible outcomes for patients worldwide.

BS ISO 27186:2020

This standard BS ISO 27186:2020 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.

This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).

This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.

This document does not specify all connector features.

This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.