BS EN ISO 13079:2011

Overview

BS EN ISO 13079:2011 specifies the requirements for laboratory glass and plastics ware, specifically designed for the measurement of the erythrocyte sedimentation rate (ESR) using the Westergren method. This standard is essential for ensuring the accuracy and reliability of ESR testing, which is a critical diagnostic tool in clinical laboratories.

Key Requirements

The standard outlines several key requirements that must be adhered to when manufacturing and using ESR tubes. These include:

• Material Specifications: The tubes must be made from glass or plastic that meets specific chemical and physical properties to ensure compatibility with blood samples.
• Dimensions: Precise dimensions are specified to ensure consistency in measurements and results.
• Calibration: Tubes must be calibrated to ensure accurate sedimentation rate readings.
• Labeling: Clear labeling is required to identify the purpose of the tubes and any relevant safety information.

Implementation Benefits

Implementing BS EN ISO 13079:2011 in laboratory practices offers numerous benefits:

• Enhanced Accuracy: By adhering to the specifications, laboratories can ensure that their ESR measurements are accurate, leading to better patient outcomes.
• Standardisation: Compliance with this standard promotes uniformity across laboratories, facilitating the comparison of results and improving inter-laboratory reliability.
• Quality Assurance: The standard provides a framework for quality control, helping laboratories to maintain high standards in testing procedures.
• Regulatory Compliance: Following this standard aids in meeting regulatory requirements, thereby reducing the risk of non-compliance penalties.

Compliance Value

Compliance with BS EN ISO 13079:2011 is crucial for laboratories involved in ESR testing. It not only ensures that the tubes used are fit for purpose but also enhances the credibility of the laboratory's testing processes. Laboratories that implement this standard can demonstrate their commitment to quality and reliability, which is essential for gaining trust from healthcare providers and patients alike.

Furthermore, adherence to this standard can facilitate smoother accreditation processes, as it aligns with international best practices in laboratory testing. By maintaining compliance, laboratories can also mitigate risks associated with inaccurate testing, which can lead to misdiagnosis and inappropriate treatment plans.

In conclusion, BS EN ISO 13079:2011 serves as a vital reference for laboratories engaged in the measurement of erythrocyte sedimentation rates. Its implementation not only enhances the quality of testing but also supports compliance with regulatory frameworks, ultimately contributing to improved healthcare outcomes.