BS IEC 60747-14-10:2019 - Semiconductor Devices: Performance Evaluation Methods for Wearable Glucose Sensors

In the rapidly evolving world of medical technology, the need for precise and reliable performance evaluation methods is paramount. The BS IEC 60747-14-10:2019 standard provides a comprehensive framework for assessing the performance of semiconductor sensors, specifically designed for wearable glucose monitoring devices. Released on November 22, 2019, this standard is an essential resource for manufacturers, researchers, and healthcare professionals who are involved in the development and implementation of glucose monitoring technologies.

Overview of the Standard

The BS IEC 60747-14-10:2019 standard, with the ISBN 978 0 580 96651 4, is a meticulously crafted document that spans 36 pages. It outlines the methodologies and criteria necessary for evaluating the performance of semiconductor sensors used in wearable glucose sensors. This standard is crucial for ensuring that these devices meet the high standards required for medical applications, providing accurate and reliable glucose readings for users.

Key Features and Benefits

• Comprehensive Evaluation Methods: The standard provides detailed methods for assessing various performance aspects of wearable glucose sensors, including accuracy, reliability, and sensitivity.
• Industry Relevance: As a recognized standard, it aligns with global industry practices, ensuring that devices meet international quality and safety benchmarks.
• Facilitates Innovation: By providing a clear framework for performance evaluation, the standard encourages innovation and development in the field of wearable medical devices.
• Enhanced User Safety: Ensures that wearable glucose sensors provide accurate readings, which is critical for the safety and well-being of users who rely on these devices for managing their health.

Importance in the Medical Device Industry

Wearable glucose sensors are a vital component of modern diabetes management, offering users the ability to monitor their glucose levels continuously and non-invasively. The BS IEC 60747-14-10:2019 standard plays a crucial role in the medical device industry by setting the benchmark for the performance of these sensors. By adhering to this standard, manufacturers can ensure that their products are not only effective but also safe for consumer use.

Moreover, the standard supports regulatory compliance, helping manufacturers navigate the complex landscape of medical device regulations. This is particularly important in a field where precision and reliability can significantly impact patient outcomes.

Who Should Use This Standard?

The BS IEC 60747-14-10:2019 standard is an invaluable resource for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: Companies involved in the design and production of wearable glucose sensors can use this standard to guide their development processes and ensure product quality.
• Researchers: Academic and industry researchers can leverage the methodologies outlined in the standard to conduct studies and develop new technologies in glucose monitoring.
• Healthcare Professionals: Medical practitioners and healthcare providers can use the standard to better understand the capabilities and limitations of wearable glucose sensors, aiding in patient education and device selection.

Conclusion

In conclusion, the BS IEC 60747-14-10:2019 standard is a critical document for anyone involved in the development, production, or use of wearable glucose sensors. By providing a robust framework for performance evaluation, it ensures that these devices meet the highest standards of accuracy and reliability, ultimately enhancing the quality of care for individuals managing diabetes. As the demand for wearable medical technology continues to grow, adherence to this standard will be essential for maintaining trust and efficacy in the healthcare industry.

BS IEC 60747-14-10:2019

• 31.080.01 Semiconductor devices in general

This part of IEC 60747-14 specifies the terms, definitions, symbols, tests, and performance evaluation methods used to determine the performance characteristics of wearable electrochemical-glucose sensors for practical use. This document is applicable to all wearable electrochemical-glucose sensors for consumers and manufacturers, without any limitations on device technology and size.