BS EN 12353:2021

BS EN 12353:2021 - Comprehensive Guidelines for Health Care Technology

The BS EN 12353:2021 standard is an essential document for professionals in the health care technology sector. Published on September 1, 2021, this standard provides a cohesive framework for the management and assessment of medical devices and health technologies, ensuring their safety, efficacy, and performance.

With the ISBN 978 0 539 02999 4, this standard represents the latest consensus in health care technology protocols, particularly in relation to device validation and verification processes. BS EN 12353:2021 is designed to align with international best practices, facilitating harmonization across regulatory frameworks and promoting operational efficiencies.

The document is a necessary reference for various stakeholders including manufacturers, regulatory bodies, and healthcare providers, all of whom are required to meet stringent compliance guidelines. The definitive specifications within this standard guide users through critical evaluations and assessments that impact the entirety of health care service delivery.

Key sections of BS EN 12353:2021 address:

• Risk Management: Detailed methodologies for identifying, analyzing, and mitigating risks associated with medical devices.
• Clinical Evaluation: Frameworks to assess medical device performance and outcomes in real-world settings.
• Post-Market Surveillance: Guidance for ongoing monitoring and evaluation of devices post-deployment to ensure continued safety and efficacy.

This comprehensive standard stands as a cornerstone document that not only aids in regulatory compliance but also contributes to enhanced patient safety and improved health outcomes. Available in both hardcopy and PDF formats, BS EN 12353:2021 is priced competitively at £362.00. This investment is a pragmatic step towards upholding the highest standards of health care technology.

In summary, BS EN 12353:2021 is not merely an academic resource; it is a practical guide that empowers health care technology stakeholders to operate within globally accepted frameworks. By implementing the guidelines outlined in this standard, organizations can significantly enhance their operational procedures, align with regulatory expectations, and ultimately, ensure better health care delivery.