BS EN ISO 20166-4:2021 - Molecular in vitro diagnostic examinations

Introducing the BS EN ISO 20166-4:2021, a comprehensive standard that sets the benchmark for molecular in vitro diagnostic examinations, specifically focusing on the preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue in situ detection techniques. This standard is an essential resource for laboratories and professionals involved in molecular diagnostics, ensuring the highest quality and consistency in preexamination processes.

Key Features and Benefits

The BS EN ISO 20166-4:2021 standard is meticulously designed to provide detailed specifications that enhance the reliability and accuracy of molecular diagnostic examinations. Here are some of the key features and benefits:

• Comprehensive Guidelines: This standard offers a complete set of guidelines for preexamination processes, ensuring that all steps are performed with precision and consistency.
• Enhanced Accuracy: By adhering to the specifications outlined in this standard, laboratories can achieve higher accuracy in their diagnostic results, leading to better patient outcomes.
• Quality Assurance: The standard provides a framework for quality assurance, helping laboratories maintain high standards in their diagnostic processes.
• International Recognition: As an ISO standard, it is recognized globally, facilitating international collaboration and standardization in molecular diagnostics.

Specifications

The BS EN ISO 20166-4:2021 standard is a detailed document that spans 36 pages, providing in-depth information and specifications. It was officially released on July 28, 2021, and carries the ISBN 978 0 539 01276 7. This standard is currently in effect and serves as a critical resource for professionals in the field.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals and organizations, including:

• Clinical Laboratories: Laboratories conducting molecular diagnostic examinations will find this standard invaluable for ensuring the accuracy and reliability of their processes.
• Research Institutions: Researchers working with FFPE tissue samples can utilize this standard to enhance the quality and consistency of their experimental results.
• Healthcare Providers: Healthcare facilities that rely on molecular diagnostics for patient care can benefit from the standardized processes outlined in this document.
• Regulatory Bodies: Organizations involved in the regulation and oversight of diagnostic processes can use this standard as a benchmark for compliance and quality assurance.

Why Choose BS EN ISO 20166-4:2021?

Choosing the BS EN ISO 20166-4:2021 standard means opting for a document that is at the forefront of molecular diagnostic standards. Here are some reasons why this standard is a must-have:

• Expertly Crafted: Developed by leading experts in the field, this standard reflects the latest advancements and best practices in molecular diagnostics.
• Comprehensive Coverage: It covers all aspects of preexamination processes, leaving no stone unturned in ensuring the highest quality standards.
• Future-Proof: With its focus on current and emerging techniques, this standard is designed to remain relevant as the field of molecular diagnostics evolves.

Conclusion

The BS EN ISO 20166-4:2021 standard is an essential tool for anyone involved in molecular in vitro diagnostic examinations. Its detailed specifications for preexamination processes for FFPE tissue in situ detection techniques ensure that laboratories and professionals can achieve the highest levels of accuracy and reliability in their work. By adopting this standard, you are not only enhancing the quality of your diagnostic processes but also contributing to the global standardization and improvement of molecular diagnostics.

Invest in the BS EN ISO 20166-4:2021 standard today and take a significant step towards excellence in molecular diagnostics.

BS EN ISO 20166-4:2021

This standard BS EN ISO 20166-4:2021 Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.

This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities.

This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1 , ISO 20166-2 and ISO 20166-3 , Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively.

Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively.