Health Care Technology Official British Standard

PD CEN/TS 17626:2021

Explore PD CEN/TS 17626:2021 - a vital standard for health care technology, ensuring safety and efficacy across medical devices and practices.

PD CEN/TS 17626:2021 - Comprehensive Standards for Health Care Technology

The PD CEN/TS 17626:2021 is an essential technical specification designed for professionals in the health care technology landscape. Published on May 10, 2021, this document is pivotal for ensuring alignment with contemporary standards and safety protocols in healthcare practices. As healthcare technology rapidly evolves, the need for rigorous specifications such as these becomes paramount.

This standard serves multiple purposes, including the assessment of medical devices, the facilitation of interoperability among different technologies, and the enhancement of overall patient safety. It provides a structured framework for evaluating health care technologies against established benchmarks that reflect both efficacy and safety.

With its comprehensive guidelines, the PD CEN/TS 17626:2021 addresses various aspects of health care technology, including but not limited to:

  • Technical requirements for device management.
  • Quality assurance procedures for technology vendors.
  • Compliance with European and international health regulations.

This specification is particularly valuable for manufacturers, service providers, and regulatory bodies who are tasked with developing or overseeing health care technologies. By adhering to the guidelines established in this document, stakeholders can enhance the reliability and performance of medical devices, ultimately leading to improved patient outcomes.

Moreover, the PD CEN/TS 17626:2021 provides insights into best practices for mitigating risks associated with health technologies. It outlines a comprehensive approach to risk management, ensuring that potential hazards are identified, evaluated, and mitigated effectively.

Available in both PDF and hardcopy formats, this standard is priced at £258.00, a worthwhile investment for any organization involved in health care technology. The document is easily accessible and offers the clarity and detail necessary for successful implementation of its provisions.

In summary, the PD CEN/TS 17626:2021 is not just a guideline; it is a critical tool for ensuring that health care technologies meet the demands of modern medical environments. By adopting these specifications, organizations can promote safer, more effective health care solutions that are aligned with the latest industry standards.

Technical Information

Health Care Technology
BSI Group
978 0 539 06269 4
Specification Details
  • Molecular in vitro diagnostic examinations
  • Specifications for pre-examination processes for human specimen
  • Isolated microbiome DNA
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