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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.20 Biological evaluation of medical devices>21/30425530 DC BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test Part 2. Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
immediate downloadReleased: 2021-04-30
21/30425530 DC BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test Part 2. Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

21/30425530 DC

BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test Part 2. Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

CURRENCY
LANGUAGE
English
Standard number:21/30425530 DC
Pages:25
Released:2021-04-30
Status:Draft for Comment
DESCRIPTION

21/30425530 DC


This standard 21/30425530 DC BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test is classified in these ICS categories:
  • 11.100.20 Biological evaluation of medical devices

This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories.

This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted.

This document has been developed to guide manufacturers in the conduct of performance evaluation studies.


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