PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations

Standard Number: PD CEN/TS 17688-1:2021

Pages: 42

Released: 2021-12-23

ISBN: 978 0 539 06270 0

Name: Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) Isolated cellular RNA

Status: Standard

Overview

Introducing the PD CEN/TS 17688-1:2021, a comprehensive standard that sets the benchmark for molecular in vitro diagnostic examinations. This document provides detailed specifications for pre-examination processes for Fine Needle Aspirates (FNAs) and isolated cellular RNA, ensuring the highest quality and reliability in diagnostic results.

Key Features

• Standard Number: PD CEN/TS 17688-1:2021
• Pages: 42
• Release Date: December 23, 2021
• ISBN: 978 0 539 06270 0
• Status: Standard

Why Choose PD CEN/TS 17688-1:2021?

The PD CEN/TS 17688-1:2021 standard is essential for laboratories and healthcare facilities that perform molecular in vitro diagnostic examinations. It provides a clear and concise framework for the pre-examination processes of Fine Needle Aspirates (FNAs) and isolated cellular RNA, ensuring that all procedures are carried out with precision and accuracy.

Ensuring Quality and Reliability

With the PD CEN/TS 17688-1:2021 standard, you can be confident that your diagnostic processes meet the highest standards of quality and reliability. This standard outlines the best practices for handling and processing FNAs and isolated cellular RNA, minimizing the risk of errors and ensuring consistent results.

Comprehensive Guidelines

This 42-page document provides comprehensive guidelines for the pre-examination processes of FNAs and isolated cellular RNA. It covers all aspects of the process, from sample collection and handling to storage and transportation, ensuring that every step is performed correctly and efficiently.

Up-to-Date Information

Released on December 23, 2021, the PD CEN/TS 17688-1:2021 standard contains the most up-to-date information and best practices for molecular in vitro diagnostic examinations. By adhering to this standard, you can ensure that your laboratory is using the latest techniques and methodologies.

Who Should Use This Standard?

The PD CEN/TS 17688-1:2021 standard is designed for use by a wide range of professionals in the healthcare and diagnostic industries, including:

• Laboratory technicians and scientists
• Healthcare providers and clinicians
• Diagnostic equipment manufacturers
• Quality assurance and regulatory professionals

Benefits of Using PD CEN/TS 17688-1:2021

By implementing the PD CEN/TS 17688-1:2021 standard in your laboratory or healthcare facility, you can enjoy a range of benefits, including:

• Improved Accuracy: Ensure that your diagnostic results are accurate and reliable by following the best practices outlined in this standard.
• Enhanced Efficiency: Streamline your pre-examination processes and reduce the risk of errors, saving time and resources.
• Compliance: Meet regulatory requirements and industry standards by adhering to the guidelines provided in this document.
• Quality Assurance: Maintain the highest standards of quality in your diagnostic processes, ensuring consistent and dependable results.

Conclusion

The PD CEN/TS 17688-1:2021 standard is an invaluable resource for any laboratory or healthcare facility involved in molecular in vitro diagnostic examinations. By providing clear and comprehensive guidelines for the pre-examination processes of Fine Needle Aspirates (FNAs) and isolated cellular RNA, this standard ensures that your diagnostic processes are carried out with the utmost precision and accuracy.

Invest in the PD CEN/TS 17688-1:2021 standard today and take the first step towards improving the quality and reliability of your diagnostic results.

PD CEN/TS 17688-1:2021

This standard PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems
• 11.100.10 In vitro diagnostic test systems

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine RNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA. This document is not applicable for RNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.