BS EN ISO 11117:2019 - Essential Standard for Healthcare Technology

The BS EN ISO 11117:2019 is a pivotal standard within the healthcare technology sector, developed to establish a robust framework for the requirements and testing methods related to the safety and performance of medical electrical equipment. Released on April 17, 2020, this standard is designed to ensure that medical devices meet stringent guidelines to uphold the highest levels of patient safety and technological reliability.

Adhering to this standard is crucial for manufacturers and stakeholders involved in the creation, distribution, and regulation of healthcare technology. The ISO 11117:2019 framework, recognized globally, provides the basis for compliance with essential safety requirements and performance characteristics that modern medical devices must fulfill. This ensures that healthcare practitioners can rely on technology that enhances patient care and minimizes risks.

The standard outlines essential specifications, including detailed criteria for risk management, usability, and design verification. Emphasis is placed on the need for a comprehensive assessment of electrical equipment, highlighting the significance of rigorous testing protocols to verify that each device can perform safely and effectively in real-world settings. Additionally, the document serves as a guide for quality assurance processes aimed at safeguarding both clinical outcomes and patient welfare.

Professionals in the field of healthcare technology will find this standard invaluable, providing key insights into internationally recognized practices. Moreover, it aids manufacturers in aligning their products with current regulatory requirements, thereby fostering innovation while ensuring adherence to safety standards.

By investing in the BS EN ISO 11117:2019, healthcare organizations and manufacturers not only improve their compliance status but also enhance their competitive edge in a rapidly evolving market. Priced at £220.00, this essential document is available in both PDF and hard copy formats, ensuring accessibility for all stakeholders.

In summary, the BS EN ISO 11117:2019 standard is a necessity for those involved in the healthcare technology domain. It empowers organizations to design, manufacture, and deliver reliable medical devices that adhere to international safety laws, ultimately contributing to improved patient health outcomes and the advancement of medical technology.