BS EN ISO 7199:2016+A1:2020 - Comprehensive Standard for Cardiopulmonary Bypass Equipment

The BS EN ISO 7199:2016+A1:2020 standard provides essential guidelines for the design, safety, and performance of cardiopulmonary bypass (CPB) equipment. This critical component of health care technology ensures that medical professionals can effectively and safely manage blood circulation and oxygenation for patients undergoing cardiac surgery and other medical procedures requiring temporary support of the circulatory system.

Developed with the intent to enhance the quality of patient care, this standard stipulates rigorous testing procedures and operational requirements that CPB equipment must meet. The incorporation of the amendment A1:2020 signifies the commitment to continual improvement and adaptation in the rapidly evolving field of medical technology.

BS EN ISO 7199:2016+A1:2020 is an identical adoption of ISO 7199:2016/Amd.1:2020, ensuring alignment with international best practices and promoting global consistency in the healthcare sector. The comprehensive nature of this standard covers vital elements such as performance criteria, testing protocols, and safety mechanisms to avert risks associated with the use of CPB systems.

The document serves as an authoritative reference for manufacturers, healthcare providers, and regulatory bodies, facilitating compliance with regional and international health and safety regulations. By adhering to the standards outlined, manufacturers can demonstrate their commitment to producing high-quality, reliable equipment that meets the critical needs of cardiac surgery and emergency medical situations.

Investing in the BS EN ISO 7199:2016+A1:2020 standard is paramount for organizations aiming to enhance their operational effectiveness and ensure the highest standard of patient safety. The cost of £258.00 provides access to this essential document in both PDF and hardcopy formats, offering flexibility for various institutional needs.

This standard is not only a regulatory requirement but also a vital tool in fostering innovation and ensuring best practices in the design and application of CPB systems. By integrating the standards into their operations, healthcare providers can significantly contribute to improved patient outcomes and the overall efficiency of cardiac care.