BS EN ISO 18113-2:2011
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In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
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CLSI GP29 A2 : 2ED 2008
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ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
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DIN EN ISO 18113-4:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
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CLSI H42 A2 : 2ED 2007
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ENUMERATION OF IMMUNOLOGICALLY DEFINED CELL POPULATIONS BY FLOW CYTOMETRY
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CLSI H54 A : 1ED 2005
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PROCEDURES FOR VALIDATION OF INR AND LOCAL CALIBRATION OF PT/INR SYSTEMS
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CLSI H45 A2 : 2ED 2005
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PERFORMANCE OF THE BLEEDING TIME TEST
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BS EN ISO 18113-4:2011
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In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
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UNE-EN ISO 18113-2:2012
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
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UNI EN ISO 18113-4 : 2012
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
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CLSI H21 A5 : 5ED 2008
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COLLECTION, TRANSPORT, AND PROCESSING OF BLOOD SPECIMENS FOR TESTING PLASMA-BASED COAGULATION ASSAYS AND MOLECULAR HEMOSTASIS ASSAYS
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CLSI I/LA2 A2 : 2ED 2006
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QUALITY ASSURANCE OF LABORATORY TESTS FOR AUTOANTIBODIES TO NUCLEAR ANTIGENS: (1) INDIRECT FLUORESCENCE ASSAY FOR MICROSCOPY AND (2) MICROTITER ENZYME IMMUNOASSAY METHODS
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CLSI H57 A : 1ED 2008
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PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
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UNE-EN ISO 18113-4:2012
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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UNE-EN ISO 18113-1:2012
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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DIN EN ISO 18113-2:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
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CLSI EP15 A2 : 2ED 2006
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USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
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CLSI H57 P : 1ED 2007
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PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
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UNI EN ISO 18113-2 : 2012
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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I.S. EN ISO 18113-1:2011
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
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I.S. EN ISO 18113-4:2011
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
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ISO 18113-2:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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BS EN 13612:2002
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Performance evaluation of in vitro diagnostic medical devices
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ISO 18113-4:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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ISO 18113-1:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
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EN ISO 18113-1:2011
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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DIN EN ISO 18113-1:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
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BS EN ISO 18113-1:2011
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In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
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I.S. EN ISO 18113-2:2011
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
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UNI EN ISO 18113-1 : 2012
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
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