BS ISO 11658:2012
Discover BS ISO 11658:2012, the standard for health care technology management, focusing on safety, efficiency, and risk management in medical devices.
BS ISO 11658:2012 - Health Care Technology Standard
BS ISO 11658:2012 is a comprehensive international standard designed to provide guidelines and protocols for healthcare technology, ensuring the safe and effective management of medical devices. Published on May 31, 2012, this standard aligns with the latest developments in health technology management, facilitating the integration of advanced healthcare solutions into clinical settings.
This standard addresses the critical aspects of health technology by focusing on various components including the life cycle management of medical devices, from procurement and usage to maintenance and decommissioning. It lays out essential requirements for the evaluation of healthcare technology systems, aiming to enhance patient safety and optimize operational efficiency.
One of the key features of BS ISO 11658:2012 is its emphasis on risk management. The standard guides healthcare professionals on identifying, assessing, and mitigating risks associated with medical devices, thus safeguarding patient wellbeing. It promotes a systematic approach to health technology assessment (HTA), which helps organizations make informed decisions regarding the adoption of new medical technologies.
Moreover, this standard encourages a collaborative environment involving all stakeholders, including healthcare providers, manufacturers, and regulatory bodies. By establishing a common framework for communication and reporting, it enhances the quality of service delivery within healthcare systems.
For organizations in the healthcare sector, adherence to BS ISO 11658:2012 not only ensures compliance with regulatory requirements but also elevates the standard of care provided to patients. It serves as an essential tool for quality assurance, driving continuous improvement and innovation in medical technology management.
The document is available in both PDF and hardcopy formats, making it accessible for various organizational needs. Pricing is set at £158.00, representing a valuable investment in the continued advancement of healthcare practices.
In summary, BS ISO 11658:2012 serves as a pivotal resource for healthcare professionals aiming to achieve excellence in technology management. By adhering to this standard, organizations can significantly enhance their operational performance and elevate the standard of care provided to patients.
Technical Information
Specification Details
- Cardiovascular implants and extracorporeal systems
- Blood/tissue contact surface modifications for extracorporeal perfusion systems