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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 20166-4:2022

Status: VIGENTE / 2022-03-16

Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)

UNE-EN ISO 6717:2022

Status: VIGENTE / 2022-03-16

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

UNE-EN ISO 20184-3:2022

Status: VIGENTE / 2022-03-02

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

UNE-EN ISO 23118:2022

Status: VIGENTE / 2022-03-02

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)

UNE-ISO 15190:2022

Status: VIGENTE / 2022-03-02

Medical laboratories — Requirements for safety

UNE-EN ISO 17511:2022

Status: VIGENTE / 2022-03-02

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

UNE-CEN/TS 17688-1:2021 (Ratificada)

Status: VIGENTE / 2022-02-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-CEN/TS 17688-2:2021 (Ratificada)

Status: VIGENTE / 2022-02-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-CEN/TS 17688-3:2021 (Ratificada)

Status: VIGENTE / 2022-02-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-EN ISO 16256:2021 (Ratificada)

Status: VIGENTE / 2021-12-01

Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021) (Endorsed by Asociación Española de Normalización in December of 2021.)

UNE-ISO 35001:2021

Status: VIGENTE / 2021-03-17

Biorisk management for laboratorios and other related organisations

UNE-EN ISO 20776-1:2021

Status: VIGENTE / 2021-02-10

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)

UNE-EN ISO 22367:2020

Status: VIGENTE / 2020-10-21

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

UNE-EN ISO 20186-3:2020

Status: VIGENTE / 2020-09-23

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

UNE-EN 13641:2002

Status: VIGENTE / 2020-02-20

Elimination or reduction of risk of infection related to in vitro diagnostic reagents.

UNE-EN 13612:2002

Status: VIGENTE / 2020-02-20

Performance evaluation of in vitro diagnostic medical devices.

UNE-EN 13975:2003

Status: VIGENTE / 2020-02-20

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

UNE-EN 13532:2002

Status: VIGENTE / 2020-02-20

General requirements for in vitro diagnostic medical devices for self-testing.

UNE-EN 14136:2004

Status: VIGENTE / 2020-02-20

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

UNE-EN ISO 20186-2:2020

Status: VIGENTE / 2020-01-08

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)

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