BS EN 17387:2021 - Standard for Health Care Technology

The BS EN 17387:2021 is a pivotal British Standard that establishes a technical framework for health care technology. Published on August 18, 2021, this standard provides comprehensive specifications and guidelines tailored to enhance the safety and efficiency of health care technologies, ensuring optimal performance in various medical environments.

This publication offers vital insights into the essential requirements for the implementation and utilization of health care technologies. Aimed at manufacturers, healthcare professionals, and regulatory bodies, it bridges the gap between innovation and safety, emphasizing the need for robust testing, validation, and compliance with European norms.

The standard outlines critical parameters that health care devices must meet to ensure reliability and efficacy. It addresses various facets including operational performance, safety regulations, and risk management processes. By adhering to BS EN 17387:2021, stakeholders can significantly reduce the likelihood of adverse incidents associated with medical device usage.

Key components of the standard include detailed descriptions of the performance evaluation criteria, which are essential for demonstrating conformity with regulatory requirements. The clear guidelines on risk assessment emphasize the importance of identifying potential hazards related to medical technology, thus ensuring proactive measures are in place to mitigate risks.

In addition, BS EN 17387:2021 is formatted for convenience, available in both PDF and hardcopy versions, making it accessible for various users. Priced at £258.00, the investment in this standard represents a commitment to adhering to best practices in healthcare technology management and implementation.

This document is not only a tool for compliance but also acts as a resource for ongoing quality improvement initiatives. By following the structured approach outlined in BS EN 17387:2021, organizations can not only meet regulatory expectations but also advance patient care and operational excellence. Adopting this standard is crucial in today's rapidly evolving health care landscape, where technological advancements require equally sophisticated frameworks for safety and effectiveness.