Health Care Technology Official British Standard

18/30384670 DC

Explore British Standard 18/30384670 DC for health care technology compliance, detailing IEC 60118-16 Ed.1.0. Enhance safety and efficacy in medical devices.

British Standard 18/30384670 DC: IEC 60118-16 Ed.1.0

The British Standard 18/30384670 DC, published in November 2018, defines critical specifications for health care technology, focusing on the high standards necessary for ensuring the safety and efficacy of medical devices. This document serves as a vital resource for professionals involved in the design, manufacture, and quality assurance processes within the medical technology sector.

Grounded in the international standard IEC 60118-16, this edition offers an identical replication of the standards that govern hearing aids and similar devices. It is designed to streamline compliance with both national and international regulatory requirements, thereby enhancing the reliability and quality of health care technology across various applications.

Healthcare professionals and technology developers will find that adherence to these guidelines not only facilitates improved patient outcomes but also supports innovations in hearing assistive technologies. The document is structured to provide detailed technical specifications that address the performance, testing methods, and quality assurance measures essential for modern medical devices.

Key areas of focus within this standard include:

  • Performance Requirements: Addresses the vital performance benchmarks that must be met to ensure device efficacy.
  • Testing Methodologies: Outlines standardized methods for evaluating device performance, durability, and safety.
  • Quality Control Measures: Provides a framework for ongoing quality assurance processes, ensuring devices remain compliant throughout their lifecycle.

By investing in the British Standard 18/30384670 DC document, stakeholders gain access to vital information that can enhance their product offerings and ensure compliance with the latest industry standards.

The document is available in both PDF and hardcopy formats, making it accessible for a variety of professional environments. For a price of £20.00, this reference guide is an indispensable tool for organizations that prioritize quality in health care technology.

In summary, the British Standard 18/30384670 DC offers a comprehensive framework for the evaluation and assurance of hearing assistance devices, supporting the continued advancement of health care technologies in line with global best practices.

Technical Information

Health Care Technology
BSI Group
Specification Details
  • BS IEC 63219
  • Definition and verification of hearing aid features
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