BS EN ISO 15002:2008+A1:2019 - A Comprehensive Standard for Healthcare Technology

The BS EN ISO 15002:2008+A1:2019 standard is an essential document for professionals working in the realm of healthcare technology. This standard outlines the requirements for the safe and effective use of medical devices, ensuring that they meet performance specifications while maintaining a high standard of patient safety.

Originally published in August 2008, this updated version integrates amendments made in 2019, ensuring that the standard stays relevant in the evolving landscape of healthcare. The document serves as a guideline for manufacturers, developers, and users of healthcare technologies, providing a framework to evaluate and enhance medical device performance and usability.

With a comprehensive approach, this standard addresses critical aspects such as risk management, usability engineering, and performance requirements. It ensures that medical devices not only comply with regulatory standards but also meet the expectations of healthcare professionals and patients alike.

This document is essential for organizations involved in the lifecycle of healthcare technology—from research and development to production and post-market surveillance. It allows stakeholders to assess the quality and efficacy of medical devices, fostering a commitment to continuous improvement in healthcare delivery.

Acquiring the BS EN ISO 15002:2008+A1:2019 standard is an investment in ensuring compliance and maintaining a high standard of care within healthcare facilities. Priced at £220.00, the document is available in both PDF and hardcopy formats, catering to diverse preferences among healthcare professionals.

In summary, BS EN ISO 15002:2008+A1:2019 is a critical resource for any organization aiming to enhance the safety and effectiveness of its medical devices. By adhering to this standard, stakeholders can contribute to advancing healthcare technology and improving patient outcomes.