CLSI EP6 A : 1ED 2003
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
Available format(s)
Hardcopy , PDF
Superseded date
10-06-2023
Superseded by
Language(s)
English
Published date
12-01-2013
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.Covers guidelines for characterizing the linearity of a method during a method evaluation: for checking linearity as part of routine quality assurance: and for determining and stating a manufacture's claim for linear range.
| DevelopmentNote |
Supersedes NCCLS EP6 P2 (05/2003)
|
| DocumentType |
Miscellaneous Product
|
| Pages |
62
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI GP31 P : 1ED 2007 | LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE |
| CLSI EP32 R : 1ED 2006 | METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION |
| CLSI H56 A : 1ED 2006 | BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI GP37 P : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| CLSI H48 : 2ED 2016 | DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY |
| CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| CLSI EP22 P : 1ED 2010 | PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES |
| CLSI C58 A : 1ED 2011 | ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT |
| CLSI MM19 A : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI EP29 A : 1ED 2012 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI H60 A : 1ED 2014 | LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT |
| 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 POCT17 : 1ED 2016 | USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS |
| CLSI EP18 P3 : 3ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI C51 P : 1ED 2010 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI MM17 P : 1ED 2007 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| 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 MM10 A : 1ED 2006 | GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION |
| CLSI EP14 A3 : 2014 | EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES |
| 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) |
| CLSI MM5 A2 : 2ED 2012 | NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
| CLSI C24 : 4ED 2016 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| 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 EP30 A : 1ED 2010 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| CLSI I/LA34 P : 1ED 2010 | DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI I/LA20 : 3ED 2016 | ANALYTICAL PERFORMANCE CHARACTERISTICS, QUALITY ASSURANCE, AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E ANTIBODIES OF DEFINED ALLERGEN SPECIFICITIES |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI NBS04 A : 1ED 2010 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br> |
| CLSI C34 A3 : 3ED 2009 | SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| CLSI C53 P : 1ED 2008 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| 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 EP17 A2 : 2ED 2012 | EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| 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 MM19 P : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| CLSI NBS05 A : 1ED 2011 | NEWBORN SCREENING FOR CYSTIC FIBROSIS |
| CLSI I/LA20 A2 : 2ED 2009 | ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES |
| CLSI MM10 P : 1ED 2005 | GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION |
| CLSI C57 : 1ED 2015 | MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| CLSI EP36 : 1EDE 2015 | HARMONIZATION OF SYMBOLOGY AND EQUATIONS |
| CLSI C50 P : 1ED 2007 | MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| 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 EP18 P2 : 2ED 2007 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI H56 P : 1ED 2005 | BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION |
| CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| CLSI EP9 A3 : 3ED 2013 | MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI MM16 A : 1ED 2006 | USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS |
| 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 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 |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| CLSI C43 A2 : 2ED 2010 | GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
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