BS EN ISO 4307:2021 - Molecular in vitro diagnostic examinations

Standard Number: BS EN ISO 4307:2021

Pages: 22

Released: 2021-11-04

ISBN: 978 0 539 14124 5

Name: Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA

Status: Standard

Overview

The BS EN ISO 4307:2021 standard is a comprehensive guideline designed to ensure the highest quality and consistency in molecular in vitro diagnostic examinations, specifically focusing on the pre-examination processes for saliva and isolated human DNA. This standard is essential for laboratories, research institutions, and healthcare providers who are involved in the collection, handling, and analysis of saliva samples for diagnostic purposes.

Key Features

• Comprehensive Guidelines: This standard provides detailed specifications for the pre-examination processes, ensuring that all steps from saliva collection to DNA isolation are performed with the highest level of accuracy and consistency.
• Quality Assurance: By adhering to the guidelines set forth in this standard, laboratories can ensure the reliability and reproducibility of their diagnostic results, which is crucial for patient care and research outcomes.
• International Standard: As an ISO standard, BS EN ISO 4307:2021 is recognized globally, making it a valuable resource for international collaborations and studies.
• Up-to-Date Information: Released on November 4, 2021, this standard incorporates the latest advancements and best practices in the field of molecular diagnostics.

Benefits

Implementing the BS EN ISO 4307:2021 standard in your laboratory or research facility offers numerous benefits:

• Enhanced Accuracy: The detailed guidelines help minimize errors and variability in the pre-examination processes, leading to more accurate diagnostic results.
• Improved Efficiency: Standardized procedures streamline the workflow, reducing the time and resources required for sample processing.
• Regulatory Compliance: Adhering to this internationally recognized standard helps ensure compliance with regulatory requirements, facilitating smoother audits and inspections.
• Increased Credibility: Following a well-established standard enhances the credibility and reliability of your laboratory's diagnostic services.

Who Should Use This Standard?

The BS EN ISO 4307:2021 standard is designed for a wide range of professionals and organizations involved in molecular diagnostics, including:

• Clinical laboratories
• Research institutions
• Healthcare providers
• Biotechnology companies
• Academic researchers

Detailed Specifications

This standard covers various aspects of the pre-examination processes for saliva and isolated human DNA, including:

• Sample Collection: Guidelines for the proper collection of saliva samples to ensure the integrity and quality of the DNA.
• Sample Handling: Procedures for the safe and effective handling of saliva samples to prevent contamination and degradation.
• DNA Isolation: Detailed steps for the isolation of high-quality human DNA from saliva samples.
• Quality Control: Recommendations for quality control measures to monitor and maintain the consistency of the pre-examination processes.

Why Choose BS EN ISO 4307:2021?

Choosing the BS EN ISO 4307:2021 standard for your molecular diagnostic examinations ensures that you are following the most up-to-date and internationally recognized guidelines. This not only enhances the quality and reliability of your diagnostic results but also positions your laboratory or research facility as a leader in the field of molecular diagnostics.

Conclusion

The BS EN ISO 4307:2021 standard is an invaluable resource for any organization involved in molecular in vitro diagnostic examinations. By providing comprehensive guidelines for the pre-examination processes for saliva and isolated human DNA, this standard helps ensure the highest level of accuracy, consistency, and reliability in diagnostic results. Whether you are a clinical laboratory, research institution, or healthcare provider, implementing this standard will enhance the quality of your diagnostic services and support better patient care and research outcomes.

BS EN ISO 4307:2021

This standard BS EN ISO 4307:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA 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. 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. Dedicated measures that need to be taken for saliva collected on absorbing materiasl or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.