CLSI MM19 P : 1ED 2011
|
ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
CLSI MM10 A : 1ED 2006
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GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION |
CLSI EP25 A : 1ED 2009
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EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
CLSI MM3 P2 : 2ED 2005
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MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
CLSI C58 A : 1ED 2011
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ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT |
BIS IS/ISO 15189 : 2012
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MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
CLSI MM19 A : 1ED 2011
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ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
I.S. EN ISO 15189:2012
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MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15) |
CLSI MM1 A3 : 3ED 2012
|
MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING |
CLSI MM17 P : 1ED 2007
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VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
CLSI H26 P2 : 2ED 2009
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VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
CLSI EP27 P : 1ED 2009
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HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS |
CLSI H57 A : 1ED 2008
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PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
CLSI C52 A2 : 2ED 2007
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TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY |
BS EN ISO 15193:2009
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In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures |
PREN ISO 15189 : DRAFT 2011
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MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
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) |
UNE-EN ISO 15189:2013
|
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
CLSI MM5 A2 : 2ED 2012
|
NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
CLSI I/LA32 P : 1ED 2009
|
NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY |
CLSI I/LA34 P : 1ED 2010
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DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
CLSI MM17 A : 1ED 2008
|
VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
11/30173018 DC : 0
|
BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
DIN EN ISO 15189:2014-11
|
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
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) |
UNI EN ISO 15189 : 2013
|
MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
CLSI I/LA34 A : 1ED 2011
|
DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
CLSI EP24 A2 : 2ED 2011
|
ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES |
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 QMS01 A4 : 4ED 2011
|
QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
CLSI MM6 A2 : 2ED 2010
|
QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
CLSI MM3 A2 : 2ED 2006
|
MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
CLSI POCT5 P : 1ED 2008
|
PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING |
CLSI C34 A3 : 3ED 2009
|
SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS |
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 |
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 |
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 15189:2012
|
Medical laboratories — Requirements for quality and competence |
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 15189:2012
|
Medical laboratories. Requirements for quality and competence |
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) |
CLSI GP16-A3 : 2009
|
Urinalysis; Approved Guideline—Third Edition |
CLSI H26 A2 : 2ED 2010
|
VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
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 C50 P : 1ED 2007
|
MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE |
CLSI EP22 P : 1ED 2010
|
PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES |
CLSI NBS04 A : 1ED 2010
|
NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
|
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 C43 A2 : 2ED 2010
|
GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS |
CLSI C46 A2 : 2ED 2009
|
BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS |
UNI EN ISO 18113-1 : 2012
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |