Standardization in the field of bacteriology relating to the performance of antimicrobial susceptibility devices which are used for testing the
susceptibility of bacteria to antibiotics in most medical laboratories. These devices should allow the categorization of bacteria as Susceptible, Intermediary or Resistant to an antibiotic given in therapy. This standard should specify requirements for antimicrobial susceptibility devices, and procedures for checking performance of such devices. The standard could be used by manufacturers as a guidance for performing a comparative evaluation with a reference method. It should allow to qualify an antimicrobial susceptibility
device and validate the transferability of the results given by the device. A bacteria which is defined as Resistant to an antibiotic by a reference method should not be defined as Susceptibility by the device. This is absolutely a fundamental point, firstly to care the infected patient, and secondly to ensure epidemiological surveillance (in this context "European" epidemiological surveillance).
Registration number (WIID)
23416
Scope
Standardization in the field of bacteriology relating to the performance of antimicrobial susceptibility devices which are used for testing the
susceptibility of bacteria to antibiotics in most medical laboratories. These devices should allow the categorization of bacteria as Susceptible, Intermediary or Resistant to an antibiotic given in therapy. This standard should specify requirements for antimicrobial susceptibility devices, and procedures for checking performance of such devices. The standard could be used by manufacturers as a guidance for performing a comparative evaluation with a reference method. It should allow to qualify an antimicrobial susceptibility
device and validate the transferability of the results given by the device. A bacteria which is defined as Resistant to an antibiotic by a reference method should not be defined as Susceptibility by the device. This is absolutely a fundamental point, firstly to care the infected patient, and secondly to ensure epidemiological surveillance (in this context "European" epidemiological surveillance).
