BS EN ISO 20166-4:2021 - Standard for Health Care Technology

BS EN ISO 20166-4:2021 is a pivotal standard within the health care technology sector, specifically designed to provide a consistent framework for the evaluation and testing of various health care equipment. Released on July 28, 2021, this standard is identical to the internationally recognized ISO 20166-4:2021, reflecting its alignment with global best practices and methodologies.

This comprehensive document serves as a vital resource for manufacturers, regulatory bodies, and health care professionals seeking to ensure safety, reliability, and efficacy in health care technology. It addresses essential criteria that must be met during the design, production, and evaluation phases of health care devices, fostering innovation while maintaining stringent safety standards.

Key Features of BS EN ISO 20166-4:2021

• Standardization: Establishes a standardized approach to the assessment of health care technologies, facilitating a common understanding among stakeholders.
• Safety Assurance: Emphasizes the importance of safety assessments, ensuring that medical devices can be reliably and safely used in clinical settings.
• Comprehensive Guidelines: Provides detailed guidelines on testing methodologies, performance metrics, and reporting requirements.
• Global Compatibility: Being aligned with ISO standards, it supports global market access and harmonization of regulatory practices.

The implementation of BS EN ISO 20166-4:2021 not only enhances the credibility of health care technology products but also assures users of their quality and effectiveness. Health care organizations, regulatory agencies, and manufacturers benefit from the clarity and structured approach set forth in this standard.

Invest in Quality

At a price of £258.00, this standard is a worthy investment for all entities involved in the health care technology landscape. By acquiring BS EN ISO 20166-4:2021, you are equipping your organization with the necessary framework to develop products that meet both consumer expectations and regulatory requirements.

Whether you are involved in research, design, manufacturing, or quality assurance, this standard serves as an indispensable guide to elevating your practices. Ensure that your health care technology products are not only innovative but also compliant with the highest safety and performance standards.