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Homepage>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
immediate downloadReleased: 2004-05-26
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

BS EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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Standard number:BS EN 14136:2004
Pages:14
Released:2004-05-26
ISBN:0 580 43819 8
Status:Standard

BS EN 14136:2004 - Elevate Your Diagnostic Procedures with Unmatched Quality Assurance

In the ever-evolving world of medical diagnostics, ensuring the accuracy and reliability of in vitro diagnostic examination procedures is paramount. Introducing the BS EN 14136:2004, a comprehensive standard that provides a robust framework for the use of external quality assessment schemes in evaluating the performance of these critical procedures. Released on May 26, 2004, this standard is an essential tool for laboratories and healthcare facilities committed to maintaining the highest standards of diagnostic accuracy.

Key Features of BS EN 14136:2004

  • Standard Number: BS EN 14136:2004
  • Pages: 14
  • Release Date: 2004-05-26
  • ISBN: 0 580 43819 8
  • Status: Standard

Why Choose BS EN 14136:2004?

The BS EN 14136:2004 standard is meticulously designed to guide laboratories in implementing external quality assessment (EQA) schemes effectively. These schemes are crucial for verifying the performance of in vitro diagnostic tests, ensuring that results are both accurate and reliable. By adhering to this standard, laboratories can enhance their diagnostic capabilities, reduce errors, and ultimately improve patient outcomes.

Comprehensive Guidance

With 14 pages of detailed instructions, the BS EN 14136:2004 provides comprehensive guidance on the application of EQA schemes. It covers all aspects of quality assessment, from the selection of appropriate schemes to the interpretation of results. This ensures that laboratories have a clear roadmap to follow, minimizing the risk of errors and enhancing the overall quality of diagnostic procedures.

Internationally Recognized

As a part of the BS EN series, this standard is recognized internationally, making it a valuable asset for laboratories operating in a global context. Compliance with BS EN 14136:2004 not only demonstrates a commitment to quality but also facilitates international collaboration and benchmarking, as laboratories can compare their performance with peers worldwide.

Enhance Diagnostic Accuracy

In vitro diagnostic tests are critical tools in modern medicine, used for everything from routine screenings to complex disease diagnostics. The accuracy of these tests can significantly impact patient care, making quality assurance a top priority. By implementing the guidelines set forth in BS EN 14136:2004, laboratories can ensure that their diagnostic procedures meet the highest standards of accuracy and reliability.

Who Can Benefit from BS EN 14136:2004?

This standard is ideal for a wide range of stakeholders in the healthcare and diagnostics sectors, including:

  • Clinical Laboratories: Ensure the accuracy and reliability of diagnostic tests, enhancing patient care and safety.
  • Healthcare Facilities: Maintain high standards of diagnostic quality, supporting better clinical decision-making.
  • Regulatory Bodies: Use as a benchmark for evaluating the quality of diagnostic procedures in various settings.
  • Diagnostic Equipment Manufacturers: Align product development with international quality standards, ensuring market readiness.

Invest in Quality with BS EN 14136:2004

In the competitive field of medical diagnostics, quality is not just an advantage—it's a necessity. The BS EN 14136:2004 standard provides the tools and guidance needed to implement effective external quality assessment schemes, ensuring that your laboratory's diagnostic procedures are second to none. By investing in this standard, you are investing in the future of healthcare, where accurate diagnostics lead to better patient outcomes and enhanced trust in medical services.

Embrace the power of quality assurance with BS EN 14136:2004 and take your diagnostic capabilities to new heights. With its comprehensive guidance and international recognition, this standard is your key to achieving excellence in in vitro diagnostic examination procedures.

DESCRIPTION

BS EN 14136:2004


This standard BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organisation; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
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