CLSI EP32 R : 1ED 2006
|
METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION |
CLSI H56 A : 1ED 2006
|
BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION |
CLSI GP37 P : 1ED 2011
|
QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
CSA ISO 15197 : 2015
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
CLSI MM7 A2 : 2ED 2013
|
FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES |
CLSI EP18 A2 : 2ED 2009
|
RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI EP26 A : 1ED 2013
|
USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION |
CLSI EP25 A : 1ED 2009
|
EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
CLSI MM3 P2 : 2ED 2005
|
MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
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 |
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 |
CLSI EP27 A : 1ED 2012
|
HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS |
CLSI EP29 A : 1ED 2012
|
EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
CLSI H60 A : 1ED 2014
|
LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT |
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 |
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 I/LA28 A2 : 2ED 2011
|
QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS |
CLSI EP18 P3 : 3ED 2009
|
RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI MM17 P : 1ED 2007
|
VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
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 |
CLSI C52 A2 : 2ED 2007
|
TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY |
PD ISO/TS 17822-1:2014
|
In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
BS EN ISO 15193:2009
|
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures |
CLSI EP17 A2 : 2ED 2012
|
EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES |
ISO/TS 17822-1:2014
|
In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions |
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) |
I.S. EN ISO 15193:2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
CLSI GP34 P : 1ED 2009
|
VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
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 EP30 A : 1ED 2010
|
CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
CLSI MM6 A2 : 2ED 2010
|
QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
CLSI EP15 A2 : 2ED 2006
|
USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
CLSI NBS04 A : 1ED 2010
|
NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
|
CLSI C51 P : 1ED 2010
|
EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
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 |
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 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 H20 A2 : 2ED 2007
|
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition
|
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 EP31 A : 1ED 2008
|
VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
CLSI NBS05 A : 1ED 2011
|
NEWBORN SCREENING FOR CYSTIC FIBROSIS |
CLSI C24 A3 : 3ED 2006
|
STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
CLSI H59 P : 1ED 2010
|
QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE |
CLSI MM10 P : 1ED 2005
|
GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION |
CLSI MM22 A : 1ED 2014
|
MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
CLSI H47 A2 : 2ED 2008
|
ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST |
CLSI I/LA32 P : 1ED 2009
|
NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY |
CLSI H57 P : 1ED 2007
|
PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
CLSI C50 P : 1ED 2007
|
MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE |
CLSI MM20 A : 1ED 2012
|
QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING |
CLSI MM3 A2 : 2ED 2006
|
MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
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 |
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) |
DIN EN ISO 15193:2009-10
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
CLSI C53 P : 1ED 2008
|
CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
CLSI MM19 A : 1ED 2011
|
ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
ISO 15193:2009
|
In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
ISO 18113-1:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
EN ISO 15193:2009
|
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) |
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 QMS01 A4 : 4ED 2011
|
QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
CLSI EP18 P2 : 2ED 2007
|
RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI GP34 A : 1ED 2010
|
VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
CLSI GP16-A3 : 2009
|
Urinalysis; Approved Guideline—Third Edition |
CLSI H56 P : 1ED 2005
|
BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION |
CLSI QMS13 A : 1ED 2011
|
QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
CLSI H59 A : 1ED 2011
|
QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE |
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 C40 A2 : 2ED 2013
|
MEASUREMENT PROCEDURES FOR THE DETERMINATION OF LEAD CONCENTRATIONS IN BLOOD AND URINE |
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 |
CLSI GP31 A : 1ED 2009
|
LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE |
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 |
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) |