Health Care Technology Official British Standard

PD IEC/TR 80001-2-9:2017

Discover PD IEC/TR 80001-2-9:2017, a vital guide for managing risks in healthcare technology integration, ensuring safety and efficacy.

PD IEC/TR 80001-2-9:2017 - Essential Guide for Healthcare Technology Management

In today’s rapidly evolving healthcare landscape, the integration of medical devices into hospital networks presents both opportunities and challenges. The PD IEC/TR 80001-2-9:2017 standard provides vital guidelines to ensure that healthcare technology is managed effectively and safely, paving the way for enhanced patient care while mitigating risks associated with interoperability.

This technical report is part of a comprehensive series dedicated to the application of risk management principles in the context of healthcare technology, particularly focusing on the risk associated with the deployment and integration of medical devices within healthcare IT networks. Released on February 28, 2017, this document caters to a diverse audience, including healthcare providers, system administrators, biomedical engineers, and healthcare technology managers.

The PD IEC/TR 80001-2-9:2017 standard outlines a framework for assessing and managing the risks linked to the use of networked medical devices. It emphasizes the importance of collaboration among stakeholders, detailing the responsibilities of medical device manufacturers, healthcare organizations, and other parties involved in healthcare technology management.

This standard delivers detailed guidance regarding:

  • Safety and effectiveness of networked medical devices
  • Risk management processes, including identification, assessment, and mitigation
  • Collaboration frameworks between IT and clinical staff
  • Implementation of best practices in device selection and integration

By adhering to the protocols established in the PD IEC/TR 80001-2-9:2017, healthcare organizations can significantly reduce the chances of adverse events caused by incompatibility or malfunction of network-integrated medical devices. The report also addresses the importance of ongoing monitoring and assessment of risk management processes to adapt to technological advancements and changing clinical needs.

Investing in this comprehensive resource, available in hardcopy and PDF formats, enables organizations to foster a safer, more efficient technology environment dedicated to improving patient outcomes. With a standard price of £258.00, the PD IEC/TR 80001-2-9:2017 is a critical addition to the libraries of healthcare facilities striving for excellence in technology management.

By setting a robust foundation for risk management in healthcare technology, this document not only aligns with regulatory requirements but also supports the advancement of integrated care solutions that are essential in today's connected health ecosystem.

Technical Information

Health Care Technology
BSI Group
978 0 580 91661 8
Specification Details
  • Application of risk management for it-networks incorporating medical devices - Application guidance
  • Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
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