CTN 129 - Clinical laboratory and in vitro diagnostic systems

Secretary:

FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA

Field of Activity:

Standardization of:

Clinical laboratory and in vitro diagnostic systems, this includes appropriate equipments in the field of haematology, haemotherapy, clinical chemistry, microbiology, immunology and anatomical pathology, concerning terms and definitions, general characteristics and performance, sterility, test methods, biocompatibility, and biological safety, good manufacturing practices, labelling, packaging and clinical trials.

Excluding:

Instruments, reagent materials or medical devices, which are within the scope of other technical committees.

Structure:

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

International Relations:

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: 104