YY/T 0688.2-2010 Active Industry standards-Medicine

YY/T 0688.2-2010 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0688.2-2010

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 10 pages

Scope

This part of YY/T 0688 establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of antimicrobials against bacteria and/or to interpret the classification of bacteria as sensitive, intermediate, or resistant (SIR) to antimicrobials. This part specifies the requirements for AST equipment (including diffusion testing systems) and the procedures for evaluating the performance of these devices. The standard defines how the performance evaluation of AST equipment is conducted. This part is used to guide manufacturers in conducting performance evaluation studies.