BS ISO 17822:2020 - In vitro Diagnostic Test Systems

Standard Number: BS ISO 17822:2020

Pages: 48

Released: January 29, 2021

ISBN: 978 0 539 16842 6

Status: Standard

Overview

The BS ISO 17822:2020 is a comprehensive standard that provides a detailed guide for laboratory quality practices in the field of in vitro diagnostic test systems. This standard focuses on nucleic acid amplification-based examination procedures, which are crucial for the detection and identification of microbial pathogens. As a laboratory quality practice guide, it is an essential resource for laboratories aiming to maintain high standards of accuracy and reliability in their diagnostic processes.

Key Features

• Comprehensive Coverage: With 48 pages of detailed guidelines, this standard offers extensive coverage of nucleic acid amplification-based examination procedures.
• Up-to-Date Information: Released on January 29, 2021, this standard reflects the latest advancements and best practices in the field of in vitro diagnostics.
• International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that laboratories adhering to it meet international quality benchmarks.

Benefits of BS ISO 17822:2020

Implementing the guidelines provided in the BS ISO 17822:2020 standard offers numerous benefits to laboratories and healthcare facilities:

• Enhanced Accuracy: By following the standardized procedures, laboratories can achieve higher accuracy in the detection and identification of microbial pathogens.
• Improved Reliability: Consistent application of the guidelines ensures reliable results, which are critical for patient diagnosis and treatment.
• Quality Assurance: The standard serves as a benchmark for quality assurance, helping laboratories to maintain and improve their diagnostic capabilities.
• Global Compliance: Adhering to an internationally recognized standard facilitates compliance with global regulations and enhances the laboratory's reputation.

Who Should Use This Standard?

The BS ISO 17822:2020 standard is designed for a wide range of professionals and organizations involved in the field of in vitro diagnostics, including:

• Clinical Laboratories: Laboratories conducting diagnostic tests for microbial pathogens will find this standard invaluable for ensuring high-quality results.
• Healthcare Facilities: Hospitals and clinics can benefit from the standard by ensuring their diagnostic services meet international quality standards.
• Research Institutions: Organizations involved in research and development of diagnostic technologies can use the standard to guide their methodologies and ensure robust outcomes.
• Regulatory Bodies: Agencies responsible for overseeing laboratory practices can use the standard as a reference for evaluating compliance and quality.

Why Choose BS ISO 17822:2020?

Choosing the BS ISO 17822:2020 standard is a strategic decision for any laboratory or healthcare facility committed to excellence in diagnostic testing. Here are some reasons why this standard stands out:

• Expertly Developed: The standard is developed by experts in the field, ensuring that it incorporates the latest scientific knowledge and practical insights.
• Comprehensive Guidelines: It provides detailed, step-by-step guidelines that cover all aspects of nucleic acid amplification-based examination procedures.
• Focus on Quality: The standard emphasizes quality practices, helping laboratories to achieve and maintain high standards of diagnostic accuracy and reliability.
• International Applicability: As an ISO standard, it is applicable across different countries and regions, making it a versatile choice for global operations.

Conclusion

The BS ISO 17822:2020 standard is an indispensable resource for any laboratory or healthcare facility involved in the detection and identification of microbial pathogens. By providing a robust framework for nucleic acid amplification-based examination procedures, it ensures that laboratories can deliver accurate, reliable, and high-quality diagnostic results. Whether you are a clinical laboratory, healthcare provider, research institution, or regulatory body, this standard offers the guidance and assurance needed to excel in the field of in vitro diagnostics.

BS ISO 17822:2020

This standard BS ISO 17822:2020 In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide is classified in these ICS categories:

• 11.100.01 Laboratory medicine in general
• 01.040.19 Testing (Vocabularies)

This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT).

It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.