BS EN ISO 17511:2021

Comprehensive Healthcare Technology Standard

BS EN ISO 17511:2021 is the essential standard for healthcare organizations and medical device manufacturers. This standard, identical to ISO 17511:2020, provides guidelines for the measurement of quantities in biological samples and for the preparation and use of calibrators and control materials in the in vitro diagnostic medical device industry.

Ensure Compliance and Quality

Adhering to the requirements outlined in BS EN ISO 17511:2021 is crucial for maintaining compliance, quality, and traceability in medical measurement and in vitro diagnostics. This standard helps organizations:

• Establish reliable and consistent measurement procedures
• Ensure the accuracy and comparability of measurement results
• Facilitate the traceability of measurement results to higher-order references
• Promote the standardization of in vitro diagnostic medical devices

Key Technical Specifications

BS EN ISO 17511:2021 covers a wide range of technical requirements and guidelines, including:

Measurement Procedures

• Principles and general requirements for measurement procedures
• Specific requirements for measurement procedures using calibrators and control materials
• Procedures for the preparation and use of calibrators and control materials

Traceability and Uncertainty

• Establishing traceability of measurement results to higher-order references
• Determining and reporting measurement uncertainty
• Procedures for the verification of traceability and measurement uncertainty

Quality Management

• Requirements for the quality management system of the manufacturer
• Procedures for the validation and verification of measurement procedures
• Guidance on the selection and use of calibrators and control materials

Benefits of Compliance

By implementing the requirements of BS EN ISO 17511:2021, healthcare organizations and medical device manufacturers can:

• Improve the reliability and accuracy of medical measurements
• Enhance the comparability of measurement results across different laboratories and devices
• Strengthen the traceability of measurement results to recognized references
• Demonstrate compliance with regulatory requirements and industry standards
• Enhance patient safety and the quality of healthcare services

Adopting BS EN ISO 17511:2021 is a crucial step towards ensuring the quality, reliability, and traceability of medical measurements and in vitro diagnostic devices. This standard is an essential resource for healthcare professionals, medical device manufacturers, and regulatory bodies in the industry.