Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems

Available format(s)

Hardcopy

Language(s)

English

Published date

01-01-2020

Publisher

Clinical Laboratory Standards Institute

This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)–cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use in diagnostic testing.

DocumentType	Standard
ISBN	1-56238-912-2
Pages	92
PublisherName	Clinical Laboratory Standards Institute
Status	Current
Supersedes	CLSI M52 : 1ED 2015

ISO 20776-2:2007	Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices
ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
CLSI EP23 A : 1ED 2011	LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
CLSI QMS01 A4 : 4ED 2011	QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
ISO/IEC Guide 63:2012	Guide to the development and inclusion of safety aspects in International Standards for medical devices
CLSI M50 A : 1ED 2008	QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS
ISO 17511:2003	In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO 9000:2005	Quality management systems Fundamentals and vocabulary
CLSI M2 A12 : 12ED 2015	PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS
CLSI LIS2 A2 : 2ED 2004	SPECIFICATION FOR TRANSFERRING INFORMATION BETWEEN CLINICAL INSTRUMENTS AND COMPUTER SYSTEMS
ISO 14971:2007	Medical devices Application of risk management to medical devices
CLSI QMS05 A2 : 2ED 2012	QUALITY MANAGEMENT SYSTEM: QUALIFYING, SELECTING, AND EVALUATING A REFERRAL LABORATORY
CLSI AUTO8 A : 1ED 2006	MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
CLSI M29 A4 : 4ED 2014	Protection of Laboratory Workers From Occupationally Acquired Infections<br>