BS EN ISO 80601-2-80:2019 - Essential Standard for Healthcare Technology

The BS EN ISO 80601-2-80:2019 is a pivotal standard in the realm of healthcare technology, specifically designed to provide essential guidelines for the safety and essential performance requirements of neonatal phototherapy equipment. This standard is crucial for manufacturers, healthcare providers, and regulatory bodies, ensuring that infants receive safe, effective treatment in critical settings.

This standard is an identical adoption of the ISO 80601-2-80:2018, reflecting its global relevance and alignment with international safety measures. Aimed at developers and manufacturers, it delineates the requirements for the design, construction, and performance of phototherapy devices, which are critical in the management of hyperbilirubinemia in neonates.

Key Features and Benefits

• Patient Safety: Establishes rigorous safety measures to minimize risks associated with phototherapy.
• Performance Standards: Sets clear performance criteria to ensure optimal efficacy in treatment.
• Compliance and Certification: Facilitates compliance with regulatory requirements, supporting market access and certification for manufacturers.
• Enhanced Understanding: Provides a comprehensive framework that fosters a deeper understanding of neonatal care technology.

Healthcare professionals can confidently implement devices that adhere to this standard, knowing they comply with best practices in safety and efficacy. Additionally, adherence to BS EN ISO 80601-2-80:2019 allows stakeholders to achieve accreditation with national and international regulatory bodies, thus investing in the future of neonatal healthcare.

How to Acquire this Standard

The standard is available for £330.00 and can be obtained in both PDF and hardcopy formats, catering to diverse operational needs of professionals and organizations within the healthcare sector. The ISBN for this important publication is 978 0 539 12003 5.

In an era where technological advancements dictate the quality of healthcare services, BS EN ISO 80601-2-80:2019 serves as an indispensable resource to help healthcare providers meet the growing demands of neonatal care while ensuring the safety and well-being of their youngest patients.