BS EN ISO 15193:2009

Comprehensive Healthcare Technology Standard

BS EN ISO 15193:2009 is the essential standard for healthcare technology professionals. This comprehensive guideline covers the critical requirements and best practices for in vitro diagnostic medical devices, ensuring quality, safety, and regulatory compliance across the industry.

Detailed Technical Specifications

Developed by leading experts, BS EN ISO 15193:2009 provides in-depth technical specifications for in vitro diagnostic medical devices, including:

• Sampling procedures and requirements
• Analytical performance characteristics
• Metrological traceability of calibrator and control material values
• Validation of examination procedures
• Estimation of measurement uncertainty

Ensure Regulatory Compliance

Adhering to the guidelines set forth in BS EN ISO 15193:2009 is crucial for healthcare organizations to demonstrate compliance with industry regulations and standards. This standard is:

• ISO Identical - Fully aligned with the latest ISO 15193:2009 standard
• EN Identical - Harmonized with European Union regulations
• Mandatory - Required for organizations operating in the healthcare technology sector

Improve Quality and Patient Safety

By implementing the best practices outlined in BS EN ISO 15193:2009, healthcare providers can:

• Enhance the reliability and accuracy of in vitro diagnostic medical devices
• Minimize the risk of errors and improve patient outcomes
• Streamline operations and increase efficiency
• Demonstrate a commitment to quality and safety to regulators and stakeholders

Obtain Your Copy Today

Stay ahead of the curve and ensure your organization's compliance with the latest healthcare technology standards. Order your copy of BS EN ISO 15193:2009 now for £220.00.