Health Care Technology Official British Standard

BS EN ISO 19980:2021

Discover BS EN ISO 19980:2021, the essential standard for health care technology. Ensure quality, safety, and compliance in medical devices and services.

BS EN ISO 19980:2021 - Comprehensive Standards for Health Care Technology

The BS EN ISO 19980:2021 standard is a pivotal document within the health care technology sector, ensuring that medical equipment and its related services uphold the highest levels of quality and safety. Published on June 25, 2021, this standard is aimed at organizations involved in the procurement, design, and manufacture of medical devices, as well as those providing health care services that rely on these technologies.

This standard, which is identical to ISO 19980:2021, offers detailed guidelines for the effective management of health care technology, including processes for assessment, lifecycle management, and risk mitigation. It emphasizes the importance of a systematic approach to integrating health care technology into clinical settings, promoting both patient safety and operational efficiency.

Key Features and Specifications

  • ISBN: 978 0 539 01154 8
  • Price: £308.00
  • Format: Available in PDF and hardcopy
  • Draft Type: European Standards (EN)
  • Sector: Health Care Technology

By adhering to the guidelines set forth in BS EN ISO 19980:2021, health care organizations can not only comply with regulatory requirements but also enhance the effectiveness of their technologies. This is vital for delivering optimal health outcomes and increasing patient satisfaction while minimizing potential hazards.

Benefits of Adoption

  • Quality Assurance: Establishes a framework for maintaining the highest quality standards in health care technology.
  • Enhanced Safety: Focuses on risk assessment and management strategies that ensure patient safety.
  • Lifecycle Management: Provides guidance on managing medical technology throughout its lifecycle, from inception to decommissioning.
  • Regulatory Compliance: Helps health care providers adhere to local and international regulatory requirements.

The landscape of health care technology is evolving rapidly, and it is essential for organizations to stay ahead of these changes. Implementing BS EN ISO 19980:2021 equips professionals with the tools necessary for informed decision-making and effective resource management in a health care environment. By leveraging this standard, organizations can foster innovation while safeguarding patient interests and maintaining operational excellence.

Technical Information

Health Care Technology
BSI Group
978 0 539 01154 8
Specification Details
  • Ophthalmic instruments
  • Corneal topographers
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