PD CEN/TS 17688-2:2021 - Molecular in vitro diagnostic examinations

Standard Number: PD CEN/TS 17688-2:2021

Pages: 30

Released: 2021-12-23

ISBN: 978 0 539 06268 7

Status: Standard

Overview

The PD CEN/TS 17688-2:2021 is a comprehensive standard that provides detailed specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated proteins in molecular in vitro diagnostic examinations. This standard is essential for laboratories and healthcare professionals who are involved in the collection, handling, and analysis of FNAs to ensure the accuracy and reliability of diagnostic results.

Key Features

• Comprehensive Guidelines: This standard offers thorough guidelines on the pre-examination processes, ensuring that all steps from collection to analysis are meticulously followed.
• Quality Assurance: By adhering to this standard, laboratories can maintain high-quality control and assurance, minimizing the risk of errors and ensuring reliable diagnostic outcomes.
• Up-to-Date Information: Released on 2021-12-23, this standard incorporates the latest advancements and best practices in the field of molecular diagnostics.
• Detailed Documentation: With 30 pages of in-depth information, this standard covers all aspects of pre-examination processes for FNAs, providing a valuable resource for professionals in the field.

Benefits

Implementing the PD CEN/TS 17688-2:2021 standard in your laboratory or healthcare facility offers numerous benefits:

• Enhanced Accuracy: By following the specified pre-examination processes, you can significantly improve the accuracy of your diagnostic results, leading to better patient outcomes.
• Consistency: Standardized procedures ensure consistency in sample handling and analysis, reducing variability and enhancing the reliability of your results.
• Compliance: Adhering to this standard helps you stay compliant with regulatory requirements and industry best practices, ensuring that your laboratory meets the highest standards of quality and safety.
• Efficiency: Clear and detailed guidelines streamline the pre-examination processes, making your workflow more efficient and reducing the time required for sample preparation and analysis.

Target Audience

The PD CEN/TS 17688-2:2021 standard is designed for a wide range of professionals involved in molecular in vitro diagnostic examinations, including:

• Clinical Laboratory Technicians
• Pathologists
• Biomedical Scientists
• Healthcare Providers
• Research Scientists

Why Choose PD CEN/TS 17688-2:2021?

Choosing the PD CEN/TS 17688-2:2021 standard ensures that you are utilizing the most current and comprehensive guidelines for pre-examination processes for FNAs isolated proteins. This standard is a valuable tool for enhancing the quality and reliability of your molecular diagnostic examinations, ultimately leading to better patient care and outcomes.

Conclusion

The PD CEN/TS 17688-2:2021 standard is an indispensable resource for any laboratory or healthcare facility involved in molecular in vitro diagnostic examinations. With its detailed guidelines and comprehensive coverage of pre-examination processes for FNAs isolated proteins, this standard helps ensure the highest levels of accuracy, consistency, and quality in your diagnostic procedures. Invest in the PD CEN/TS 17688-2:2021 standard to enhance your laboratory's performance and provide the best possible care for your patients.

PD CEN/TS 17688-2:2021

This standard PD CEN/TS 17688-2:2021 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 protein 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 examine proteins 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 20184-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins and EN ISO 20166-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.