BS EN ISO 20184-3:2021 - Molecular in vitro Diagnostic Examinations

Welcome to the world of precision and reliability in molecular diagnostics with the BS EN ISO 20184-3:2021 standard. This essential document is a cornerstone for laboratories and research facilities that focus on the pre-examination processes for frozen tissue isolated DNA. Released on June 1, 2021, this standard is a testament to the latest advancements and best practices in the field of molecular in vitro diagnostic examinations.

Overview

The BS EN ISO 20184-3:2021 standard provides comprehensive specifications for the pre-examination processes of frozen tissue isolated DNA. It is designed to ensure that the molecular diagnostic examinations are conducted with the highest level of accuracy and consistency. This standard is crucial for laboratories that aim to maintain the integrity of DNA samples and achieve reliable diagnostic results.

Key Features

• Standard Number: BS EN ISO 20184-3:2021
• Pages: 24
• Release Date: June 1, 2021
• ISBN: 978 0 539 12528 3
• Status: Standard

Why Choose BS EN ISO 20184-3:2021?

This standard is indispensable for any laboratory involved in molecular diagnostics. It provides a structured approach to handling frozen tissue samples, ensuring that the DNA remains intact and uncontaminated throughout the pre-examination process. By adhering to these specifications, laboratories can minimize errors and enhance the reliability of their diagnostic outcomes.

Benefits of Compliance

Compliance with the BS EN ISO 20184-3:2021 standard offers numerous benefits, including:

• Enhanced Accuracy: By following the specified pre-examination processes, laboratories can achieve higher accuracy in their diagnostic results.
• Consistency: The standard ensures that all procedures are consistent, reducing variability and improving the reliability of results.
• Quality Assurance: Adhering to the standard demonstrates a commitment to quality and excellence in molecular diagnostics.
• Global Recognition: As an internationally recognized standard, compliance can enhance a laboratory's reputation and credibility on a global scale.

Applications

The BS EN ISO 20184-3:2021 standard is applicable to a wide range of molecular diagnostic examinations involving frozen tissue samples. It is particularly beneficial for:

• Research laboratories conducting genetic studies and experiments.
• Clinical laboratories performing diagnostic tests for various diseases.
• Biotechnology companies involved in the development of diagnostic tools and technologies.

Structure and Content

Spanning 24 pages, the BS EN ISO 20184-3:2021 standard is meticulously structured to cover all aspects of the pre-examination process. It includes detailed guidelines on:

• Sample collection and handling procedures.
• Storage and transportation of frozen tissue samples.
• DNA isolation techniques and protocols.
• Quality control measures to ensure sample integrity.

Conclusion

In the rapidly evolving field of molecular diagnostics, the BS EN ISO 20184-3:2021 standard is an invaluable resource for ensuring the highest standards of accuracy and reliability. By implementing the specifications outlined in this standard, laboratories can enhance their diagnostic capabilities and contribute to the advancement of medical science.

Invest in the BS EN ISO 20184-3:2021 standard today and take a significant step towards excellence in molecular diagnostics.

BS EN ISO 20184-3:2021

This standard BS EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.