Health Care Technology Official British Standard

BS EN ISO 18562-1:2020

Explore BS EN ISO 18562-1:2020 for comprehensive guidelines on assessing toxic emissions from medical devices, ensuring patient safety and compliance.

BS EN ISO 18562-1:2020 - Health Care Technology

The BS EN ISO 18562-1:2020 is a critical standard that addresses the assessment of the biocompatibility of healthcare technologies. This standard is an identical adoption of ISO 18562-1:2017 and serves as a comprehensive guideline for the evaluation of materials used in medical devices, specifically focusing on the determination of toxicological risks associated with gaseous compounds emitted from these devices. As the global healthcare landscape evolves, adherence to such standards becomes imperative in ensuring patient safety and regulatory compliance.

Key Features and Benefits

  • Comprehensive Assessment: The standard provides a structured approach to identifying potential toxic volatile substances and assessing their impact on patient health.
  • Enhanced Safety: By following the guidelines set forth in BS EN ISO 18562-1:2020, manufacturers can better mitigate risks associated with emissions, promoting safer healthcare practices.
  • Regulatory Compliance: Aligning with this standard ensures that medical devices meet essential safety requirements, facilitating smoother market entry across international borders.
  • Expert Insights: Developed through extensive collaboration with industry experts, the standard embodies best practices and the latest scientific knowledge in healthcare technology.

Who Should Use This Standard?

This standard is vital for manufacturers of medical devices, regulatory bodies, safety assessors, and quality assurance professionals involved in the healthcare sector. It serves as an essential resource for conducting evaluations and ensuring that products comply with established safety norms.

Specifications

Published under the Healthcare Technology designation, the BS EN ISO 18562-1:2020 edition was released on March 31, 2017. This document comprises 32 pages and is available in both PDF and hardcopy formats. Its adherence to previous standards and the identical nature to ISO 18562-1:2017 reinforces its relevance and importance in the current medical landscape.

Investment in Quality and Safety

Purchasing the BS EN ISO 18562-1:2020 standard for £220.00 is an investment in the safety and efficacy of medical devices. By integrating these specifications into your operational framework, you demonstrate a commitment to excellence, patient safety, and quality assurance within healthcare technology. Ensure that your practices meet the highest standards by acquiring this essential document today.

Technical Information

Health Care Technology
BSI Group
978 0 539 04505 5
Specification Details
  • Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process
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