Committee:
SC 1 Terminology
SC 2 Quality systems. Reference methods and materials
SC 3 Labelling, containers and packaging. Technical and instrumentation handbooks
SC 4 General techniques for clinical laboratory
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
CEN/TC 140 In vitro diagnostic medical devices
Standards developed by the committee: CTN 129: 107
Status: ANULADA / 2018-07-01
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
Status: ANULADA / 2016-06-01
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
Status: ANULADA / 2016-04-01
IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
Status: ANULADA / 2015-12-01
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
Status: ANULADA / 2014-11-01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
Status: ANULADA / 2013-04-03
Status: ANULADA / 2013-01-01
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE.
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.
Instructions for use for in vitro diagnostic instruments for self-testing.
Instructions for use for in vitro diagnostic instruments for professional use.
Status: ANULADA / 2012-05-01
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials.
IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.
Status: ANULADA / 2012-04-18
Stability testing of in vitro diagnostic reagents.
Status: ANULADA / 2007-09-05
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2003)
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