BS EN ISO 11380:1997 - Health Care Technology Standard

The BS EN ISO 11380:1997 standard serves as an essential guideline within the healthcare technology sector. It provides comprehensive criteria and requirements for the effectiveness and safety of medical equipment. This standard is an extension of ISO 11380:1994, reflecting the continuous efforts to enhance healthcare technology and ensure its alignment with best practices in patient care and device functionality.

Published on June 15, 1995, the BS EN ISO 11380:1997 standard is crucial for manufacturers, developers, and designers of medical devices and health technology systems. Its rigorous requirements are instrumental in both optimizing device performance and ensuring the safety of patients who rely on them. By adhering to the guidelines set forth in this document, stakeholders can reduce risks associated with medical technologies while facilitating compliance with international regulations.

This standard encompasses a variety of key components including: the evaluation of health technology, methodologies for systematic assessment, and protocols for continuous monitoring and improvement. It advocates for a standardized approach that not only reinforces compliance with safety regulations but also fosters innovation in device design and functionality.

BS EN ISO 11380:1997 emphasizes the importance of evidence-based practices in evaluating health technologies. It encourages stakeholders to utilize quantitative and qualitative data in the assessment processes, thus promoting informed decision-making that can lead to improved patient outcomes and operational efficiency.

In the ever-evolving landscape of healthcare technology, staying current with such standards is vital for any entity involved in the development, production, or implementation of medical devices. By investing in this standard, stakeholders equip themselves with a knowledge base that promotes not only regulatory compliance but also operational excellence.

This document is available for purchase in both PDF and hardcopy formats at a price of £134.00. Acquiring BS EN ISO 11380:1997 will furnish your organization with the insights necessary to navigate the complexities of healthcare technology effectively, ensuring that your devices meet critical safety and performance benchmarks.

For any organization seeking to enhance its capabilities in the healthcare sector, BS EN ISO 11380:1997 is an invaluable resource that stands as a benchmark for excellence in both safety and efficacy in health technology.