CLSI EP9 A2 : 2ED 2002

Name: CLSI EP9 A2 : 2ED 2002
Brand: CLSI
Availability: InStock

Superseded

Add to Watchlist

METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES

Published date

01-12-2013

Publisher

Clinical Laboratory Standards Institute

Superseded date

08-30-2013

Superseded by

CLSI EP09c ED3:2018
CLSI EP9 A3 : 3ED 2013

Add to Watchlist

Sorry this product is not available in your region.

Addresses procedures for determining the bias between two clinical methods or devices, and for the design of a method comparison experiment using split patient samples and data analysis.

DevelopmentNote	Supersedes NCCLS EP9 A (09/2002) Interim Revision of 2ED 2002 issued on 30/07/2010. (01/2011)
DocumentType	Miscellaneous Product
PublisherName	Clinical Laboratory Standards Institute
Status	Superseded
SupersededBy	CLSI EP09c ED3:2018 CLSI EP9 A3 : 3ED 2013
Supersedes	CLSI EP9 A : 1995

Standards	Relationship
CLSI EP09c ED3:2018	Identical

CLSI EP32 R : 1ED 2006	METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
CLSI H56 A : 1ED 2006	BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
CLSI GP29 A2 : 2ED 2008	ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
CLSI MM10 P : 1ED 2005	GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
CLSI EP18 A2 : 2ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
CLSI EP25 A : 1ED 2009	EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
CLSI C58 A : 1ED 2011	ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT
CLSI EP27 A : 1ED 2012	HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS
CLSI POCT4 A2 : 2ED 2006	POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
CLSI MM19 A : 1ED 2011	ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
CLSI EP29 A : 1ED 2012	EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
CLSI POCT12 A3 : 3ED 2013	Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br>
CLSI POCT9 A : 1ED 2010	SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
CLSI MM1 A3 : 3ED 2012	MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
CLSI GP34 P : 1ED 2009	VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
CLSI H47 A2 : 2ED 2008	ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST
CLSI EP18 P3 : 3ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
CLSI EP7 A2 : 2ED 2005	INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI H26 P2 : 2ED 2009	VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
CLSI EP27 P : 1ED 2009	HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS
CLSI H57 A : 1ED 2008	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
CLSI MM10 A : 1ED 2006	GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
I.S. EN ISO 15197:2015	IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
CLSI MM5 A2 : 2ED 2012	NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
CLSI POCT9 P : 1ED 2009	SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
CLSI I/LA32 P : 1ED 2009	NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
CLSI EP15 A2 : 2ED 2006	USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI C51 P : 1ED 2010	EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
ISO 15197:2013	In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 18113-1:2011	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
CLSI GP16-A3 : 2009	Urinalysis; Approved Guideline—Third Edition
CLSI QMS01 A4 : 4ED 2011	QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI H26 A2 : 2ED 2010	VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
CLSI EP31 A : 1ED 2008	VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
CLSI MM19 P : 1ED 2011	ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
CLSI C28 P3 : 3ED 2008	DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
CLSI C24 A3 : 3ED 2006	STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI NBS05 A : 1ED 2011	NEWBORN SCREENING FOR CYSTIC FIBROSIS
CLSI GP37 P : 1ED 2011	QUALITY MANAGEMENT SYSTEM: EQUIPMENT
CLSI H57 P : 1ED 2007	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
CLSI MM6 A2 : 2ED 2010	QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
CLSI C50 P : 1ED 2007	MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
CLSI POCT5 P : 1ED 2008	PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING
CLSI NBS04 A : 1ED 2010	NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br>
11/30208525 DC : 0	BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
ISO 17593:2007	Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
I.S. EN ISO 18113-1:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
CLSI EP28 A3 : 3ED 2010	DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
CLSI I/LA25 A2 : 2011	MATERNAL SERUM SCREENING
ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
BS EN ISO 15197:2015	In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 15197:2015	In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
CLSI H56 P : 1ED 2005	BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
CLSI EP18 P2 : 2ED 2007	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
CLSI QMS13 A : 1ED 2011	QUALITY MANAGEMENT SYSTEM: EQUIPMENT
CLSI H2 A5 : 5ED 2011	PROCEDURES FOR THE ERYTHROCYTE SEDIMENTATION RATE TEST
CLSI EP22 P : 1ED 2010	PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
DIN EN ISO 18113-1:2013-01	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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
BS EN ISO 18113-1:2011	In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
CLSI C50 A : 1ED 2007	MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
CLSI C43 A2 : 2ED 2010	GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS
PREN ISO 15197 : DRAFT 2011	IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
UNE-EN ISO 15197:2015	In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE-EN ISO 18113-1:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)