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CLSI EP18 A : 1ED 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY MANAGEMENT FOR UNIT-USE TESTING

Superseded date

08-30-2007

Published date

01-12-2013

Covers quality management system for unit-use devices that will aid in the identification, understanding and management of sources of error and help to ensure correct results.

DevelopmentNote
Supersedes NCCLS EP18 P. (02/2003)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

DD CEN ISO/TS 22367:2010 Medical laboratories. Reduction of error through risk management and continual improvement
CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
CLSI POCT4 A2 : 2ED 2006 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
CLSI EP27 P : 1ED 2009 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS
CLSI POCT7 P : 1ED 2009 QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE
BS ISO 15198:2004 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
UNI CEN ISO/TS 22367 : 2010 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
DD ISO/TS 22367 : 2008 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
CLSI POCT13 A2 : 2ED 2005 GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT
S.R. CEN ISO TS 22367:2010 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement
CEN ISO/TS 22367:2010 Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)

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