PD CEN/TS 17811:2022 - Molecular in vitro Diagnostic Examinations

Specifications for Pre-examination Processes for Urine and Other Body Fluids - Isolated Cell Free DNA

Unlock the potential of molecular diagnostics with the PD CEN/TS 17811:2022 standard. This comprehensive document provides detailed specifications for pre-examination processes for urine and other body fluids, focusing on isolated cell-free DNA. Released on July 19, 2022, this standard is an essential resource for laboratories and healthcare professionals dedicated to ensuring the highest quality in molecular in vitro diagnostic examinations.

Key Features and Benefits

• Standard Number: PD CEN/TS 17811:2022
• Pages: 28
• Release Date: 2022-07-19
• ISBN: 978 0 539 06272 4
• Status: Standard

Comprehensive Coverage

This standard offers a thorough overview of the pre-examination processes required for the accurate and reliable analysis of isolated cell-free DNA from urine and other body fluids. It covers every aspect of the pre-examination phase, ensuring that laboratories can maintain the integrity and quality of their samples.

Why Choose PD CEN/TS 17811:2022?

The PD CEN/TS 17811:2022 standard is designed to meet the needs of modern molecular diagnostics. By adhering to these specifications, laboratories can:

• Ensure the highest quality and reliability of diagnostic results.
• Maintain consistency and reproducibility in pre-examination processes.
• Comply with international standards and best practices.
• Enhance the accuracy of molecular diagnostic examinations.

Detailed Specifications

The document provides detailed guidelines on various aspects of the pre-examination process, including:

• Sample collection and handling
• Storage and transportation conditions
• Processing and preparation techniques
• Quality control measures

Who Should Use This Standard?

The PD CEN/TS 17811:2022 standard is ideal for:

• Clinical laboratories
• Research institutions
• Healthcare professionals
• Diagnostic companies

Enhance Your Laboratory's Capabilities

By implementing the guidelines and specifications outlined in the PD CEN/TS 17811:2022 standard, laboratories can significantly enhance their diagnostic capabilities. This standard ensures that every step of the pre-examination process is meticulously followed, leading to more accurate and reliable results.

Stay Ahead with the Latest Standards

In the rapidly evolving field of molecular diagnostics, staying up-to-date with the latest standards is crucial. The PD CEN/TS 17811:2022 standard represents the latest advancements and best practices in the pre-examination processes for isolated cell-free DNA from urine and other body fluids.

Conclusion

Invest in the PD CEN/TS 17811:2022 standard to ensure your laboratory adheres to the highest quality and reliability standards in molecular in vitro diagnostic examinations. With its comprehensive guidelines and detailed specifications, this standard is an invaluable resource for any laboratory committed to excellence in molecular diagnostics.

Product Details

Standard Number	PD CEN/TS 17811:2022
Pages	28
Release Date	2022-07-19
ISBN	978 0 539 06272 4
Status	Standard

PD CEN/TS 17811:2022

This standard PD CEN/TS 17811:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.