CLSI M52:2010(R2020)
Current
The latest, up-to-date edition.
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
Hardcopy
English
01-01-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.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 |
| 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> |
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