99.60 Withdrawal effective Jan 19, 2022
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.20 Biological evaluation of medical devices
Published
ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.
WITHDRAWN
EN ISO 20776-2:2007
99.60
Withdrawal effective
Jan 19, 2022
PUBLISHED
EN ISO 20776-2:2022