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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 20186-1:2019

Status: VIGENTE / 2019-12-04

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)

UNE-EN ISO 20184-1:2019

Status: VIGENTE / 2019-10-23

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)

UNE-EN ISO 20184-2:2019

Status: VIGENTE / 2019-10-23

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)

UNE-EN ISO 20166-2:2019

Status: VIGENTE / 2019-10-23

Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)

UNE-EN ISO 20166-1:2019

Status: VIGENTE / 2019-10-23

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)

UNE-EN ISO 20166-3:2019

Status: VIGENTE / 2019-10-23

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)

UNE-EN ISO 15195:2019

Status: VIGENTE / 2019-10-23

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

UNE-EN 12322:1999

Status: VIGENTE / 2019-03-14

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

UNE-EN 1659:1997

Status: VIGENTE / 2019-03-14

In vitro diagnostic systems - Culture media for microbiology - Terms and definitions

UNE-EN ISO 6710:2018

Status: VIGENTE / 2018-06-06

Single-use containers for human venous blood specimen collection (ISO 6710:2017)

UNE-EN ISO 22870:2017

Status: VIGENTE / 2017-03-29

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

UNE-EN ISO 23640:2015

Status: VIGENTE / 2015-09-23

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

UNE-EN ISO 15197:2015

Status: VIGENTE / 2015-09-23

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

UNE-EN ISO 15189:2013

Status: VIGENTE / 2014-11-26

Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

UNE-EN ISO 15194:2009

Status: VIGENTE / 2014-09-03

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

UNE-EN 13612/AC:2003

Status: VIGENTE / 2014-04-09

Performance evaluation of in vitro diagnostic medical devices.

UNE-EN ISO 18153:2004

Status: VIGENTE / 2014-02-28

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

UNE-EN ISO 19001:2013

Status: VIGENTE / 2013-11-27

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

UNE-EN ISO 18113-1:2012

Status: VIGENTE / 2012-02-22

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 18113-2:2012

Status: VIGENTE / 2012-02-22

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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