What is ISO 20776?

ISO 20776 is officially titled:

"Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices"

It is divided into two parts:

  1. ISO 20776-1:2019 โ€“ AST by broth micro-dilution method
  2. ISO 20776-2:2007 โ€“ Evaluation of performance of AST devices

These standards ensure consistency in the methods used to test how effective antibiotics are against specific bacteria or infectious agents. They are used in:

  1. ๐Ÿงช Clinical microbiology laboratories
  2. ๐Ÿฅ Hospitals and diagnostic centers
  3. ๐Ÿงซ Research labs and antimicrobial R&D
  4. ๐Ÿงฌ Medical device and IVD manufacturers


Why is ISO 20776 important?

Antimicrobial resistance is a global crisis. Inaccurate or inconsistent AST results can lead to:

  1. โŒ Incorrect antibiotic prescriptions
  2. ๐Ÿฆ  Increased resistance and treatment failures
  3. ๐Ÿ’ธ Higher healthcare costs
  4. โš ๏ธ Non-compliance with clinical and regulatory standards

ISO 20776 ensures that AST results are:

  1. โœ… Standardized and reproducible
  2. ๐Ÿ“ˆ Clinically relevant and evidence-based
  3. ๐Ÿ”„ Comparable across laboratories and testing systems

This leads to more informed treatment decisions, optimized patient outcomes, and better control of AMR.

What are the benefits of ISO 20776?

Implementing ISO 20776 in your lab or diagnostic workflow offers multiple scientific and clinical benefits:

  1. ๐Ÿ“‹ Standardized Testing Methods

Use internationally accepted broth micro-dilution procedures.

  1. ๐Ÿงช Reliable Evaluation of AST Devices

Verify performance claims for commercial testing systems.

  1. ๐Ÿ” Reproducible and Comparable Results

Ensure consistency across instruments, laboratories, and regions.

  1. ๐Ÿง  Support for Evidence-Based Prescribing

Deliver accurate MIC (Minimum Inhibitory Concentration) data to guide therapy.

  1. ๐Ÿ“Š Integration with Clinical Guidelines

Align results with standards from CLSI, EUCAST, and WHO.


What kind of businesses can benefit from ISO 20776?

With GMCโ€™s guidance, implementing ISO 20776 helps your organization achieve measurable improvements:

  1. โœ… Compliance with Regulatory and Accreditation Standards

Support ISO 15189, ISO 13485, and IVDR requirements for diagnostic systems.

  1. โœ… Increased Diagnostic Accuracy

Reduce the risk of false susceptibility or resistance results.

  1. โœ… Support Product Validation for AST Devices

Strengthen documentation and validation for IVD manufacturers.

  1. โœ… Boost Laboratory Credibility and Trust

Improve confidence in reported results from clinicians and regulators.

  1. โœ… Enable Participation in Surveillance Networks

Standardized data supports reporting to national AMR surveillance programs.

  1. โœ… Better Patient Outcomes

Accurate AST results ensure timely, targeted treatment, reducing patient harm


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