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Committee

Committee:

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

UNE-EN ISO 18113-3:2012

Status: VIGENTE / 2012-02-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

UNE-EN ISO 18113-4:2012

Status: VIGENTE / 2012-02-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

UNE-EN ISO 18113-5:2012

Status: VIGENTE / 2012-02-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

UNE-EN ISO 15193:2009

Status: VIGENTE / 2009-11-25

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)

UNE-EN 12322/A1:2002

Status: VIGENTE / 2002-04-30

In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.

UNE 129002:2000 IN

Status: VIGENTE / 2000-10-27

Glossary of recommended terms in clinical laboratory sciences.

UNE 129003:2000 EX

Status: VIGENTE / 2000-03-31

Nomenclature, syntax and expression of the values of biological quantities.

UNE 129001:1997

Status: VIGENTE / 1997-01-16

CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.

UNE-EN ISO 20776-2:2008

Status: ANULADA / 2025-02-01

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007)

UNE-EN ISO 16256:2013

Status: ANULADA / 2024-11-01

Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)

UNE-EN 14254:2004

Status: ANULADA / 2024-10-01

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

UNE-EN ISO 17511:2004

Status: ANULADA / 2024-07-01

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

UNE-EN ISO 20776-1:2007

Status: ANULADA / 2023-08-01

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

UNE-EN ISO 15195:2004

Status: ANULADA / 2022-03-01

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)

UNE-EN 14820:2005

Status: ANULADA / 2020-10-01

Single-use containers for human venous blood specimen collection

UNE-EN ISO 22870:2007

Status: ANULADA / 2019-12-01

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)

UNE-ISO/TR 22869:2007 IN

Status: ANULADA / 2018-11-22

Medical laboratories. Guidance on laboratory implementation of ISO 15189: 2003. (ISO/TR 22869:2005)

UNE-EN ISO 23640:2013

Status: ANULADA / 2018-07-01

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

UNE-EN ISO 15197:2013

Status: ANULADA / 2018-07-01

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

UNE-EN ISO 15197:2004

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)

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