BS EN ISO 20776-2:2021 - Clinical Laboratory Testing and In Vitro Diagnostic Test Systems

Standard Number: BS EN ISO 20776-2:2021

Pages: 26

Released: 2022-01-21

ISBN: 978 0 539 15112 1

Status: Standard

Overview

The BS EN ISO 20776-2:2021 standard is an essential document for clinical laboratories and professionals involved in in vitro diagnostic testing. This standard provides comprehensive guidelines for the susceptibility testing of infectious agents and the evaluation of the performance of antimicrobial susceptibility test devices. It specifically focuses on the evaluation of these devices against reference broth micro-dilution, ensuring that the testing methods are accurate, reliable, and standardized across different laboratories.

Key Features

• Comprehensive Guidelines: This standard offers detailed instructions and protocols for conducting susceptibility testing of infectious agents, ensuring that laboratories can perform these tests with high accuracy and consistency.
• Performance Evaluation: It includes methodologies for evaluating the performance of antimicrobial susceptibility test devices, providing a benchmark for laboratories to assess the effectiveness of their testing equipment.
• Reference Broth Micro-Dilution: The standard emphasizes the use of reference broth micro-dilution as a gold standard for susceptibility testing, ensuring that results are comparable and reliable.
• International Standard: As an ISO standard, it is recognized and adopted globally, facilitating international collaboration and standardization in clinical laboratory testing.

Benefits

Adopting the BS EN ISO 20776-2:2021 standard in your laboratory can bring numerous benefits:

• Enhanced Accuracy: By following the standardized protocols, laboratories can achieve more accurate and reliable results in susceptibility testing.
• Improved Consistency: The standard ensures that testing methods are consistent across different laboratories, making it easier to compare and interpret results.
• Regulatory Compliance: Adhering to this ISO standard helps laboratories meet regulatory requirements and maintain high-quality testing practices.
• Global Recognition: Being an internationally recognized standard, it enhances the credibility and reputation of laboratories that implement it.

Who Should Use This Standard?

The BS EN ISO 20776-2:2021 standard is designed for a wide range of professionals and organizations involved in clinical laboratory testing and in vitro diagnostics, including:

• Clinical Microbiologists
• Laboratory Technicians
• In Vitro Diagnostic Device Manufacturers
• Regulatory Bodies
• Healthcare Institutions

Detailed Content

This 26-page standard is meticulously structured to cover all aspects of susceptibility testing and performance evaluation. Key sections include:

• Introduction: An overview of the purpose and scope of the standard.
• Normative References: A list of referenced documents that are indispensable for the application of the standard.
• Terms and Definitions: Clear definitions of terms used within the standard to ensure a common understanding.
• General Requirements: Fundamental requirements for conducting susceptibility testing and performance evaluation.
• Test Methods: Detailed descriptions of the test methods, including reference broth micro-dilution.
• Performance Criteria: Criteria for evaluating the performance of antimicrobial susceptibility test devices.
• Quality Control: Guidelines for maintaining quality control throughout the testing process.
• Reporting Results: Instructions on how to report and interpret test results.

Why Choose BS EN ISO 20776-2:2021?

The BS EN ISO 20776-2:2021 standard is a critical tool for ensuring the highest standards in clinical laboratory testing and in vitro diagnostics. By implementing this standard, laboratories can:

• Ensure Accuracy: Achieve precise and reliable results in susceptibility testing.
• Maintain Consistency: Standardize testing methods across different laboratories.
• Meet Regulatory Standards: Comply with international regulations and guidelines.
• Enhance Credibility: Gain recognition and trust from healthcare professionals and regulatory bodies.

Conclusion

The BS EN ISO 20776-2:2021 standard is an indispensable resource for any clinical laboratory or organization involved in in vitro diagnostic testing. With its comprehensive guidelines and performance evaluation criteria, it ensures that susceptibility testing of infectious agents is conducted with the highest level of accuracy and reliability. By adopting this standard, laboratories can enhance their testing capabilities, meet regulatory requirements, and contribute to the global effort in combating infectious diseases.

BS EN ISO 20776-2:2021

This standard BS EN ISO 20776-2:2021 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices